Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-26 @ 1:15 AM
Study NCT ID:
NCT07238634
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-02
First Post:
2025-11-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of DMI vs Bobath on Neuromuscular Development in CP
Sponsor:
Lahore University of Biological and Applied Sciences
Organization:
Study Overview
Official Title:
Comparative Effects of Dynamic Movement Intervention and Bobath Approach on Neuromuscular Development in Spastic Cerebral Palsy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DMINDTSCP
Brief Summary:
The goal of this clinical trial is to provide the best intervention for the spastic cerebral palsy patients. In this study the participants included • Children aged 2-4 years.
* Diagnosed with spastic diplegic cerebral palsy.
* Gross Motor Function Measurement Scale (GMFC) level I to III.
* Children who have head control.
* Ability to understand and follow simple instructions.
Exclusion Criteria:
* Visual or hearing impairments (e.g., cataract, myopia, deafness).
* Cognitive problems impacting participation.
* Uncontrolled convulsions or recent seizure activity.
* Orthopedic surgeries of the lower limbs, such as dorsal rhizotomy within the last year.
Hypothesis:
Null Hypothesis:
There is no difference in the comparative effects of DMI and Bobath therapy on neuromuscular development in children with diplegic spastic CP.
Alternate Hypothesis:
There is difference in the comparative effects of DMI and Bobath therapy on neuromuscular development in children with diplegic spastic CP.
The DMI will be compared with Bobath approach to check if the DMI works to treat Neuromuscular disorders in CP.
* Two treatment groups will be formed: Group A and Group B.
* Group A will receive intervention based on the Dynamic Movement Intervention (DMI) technique, specifically targeting improvements in neuromuscular development.
* Group B will receive therapy based on the Bobath approach, a conventional neurodevelopmental treatment method.
* Baseline assessments will be conducted by a blinded assessor prior to the initiation of intervention, followed by a second evaluation at the 6-week midpoint and a final assessment upon completion of the 12-week treatment period.
* Both interventions will be delivered over 12 weeks, with 3 sessions per week, each lasting approximately 40 minutes.
* Comparisons between the two groups will be made using pre- and post-test results to determine the relative efficacy of each intervention approach in improving gross motor function and trunk control.
* Diagnosed with spastic diplegic cerebral palsy.
* Gross Motor Function Measurement Scale (GMFC) level I to III.
* Children who have head control.
* Ability to understand and follow simple instructions.
Exclusion Criteria:
* Visual or hearing impairments (e.g., cataract, myopia, deafness).
* Cognitive problems impacting participation.
* Uncontrolled convulsions or recent seizure activity.
* Orthopedic surgeries of the lower limbs, such as dorsal rhizotomy within the last year.
Hypothesis:
Null Hypothesis:
There is no difference in the comparative effects of DMI and Bobath therapy on neuromuscular development in children with diplegic spastic CP.
Alternate Hypothesis:
There is difference in the comparative effects of DMI and Bobath therapy on neuromuscular development in children with diplegic spastic CP.
The DMI will be compared with Bobath approach to check if the DMI works to treat Neuromuscular disorders in CP.
* Two treatment groups will be formed: Group A and Group B.
* Group A will receive intervention based on the Dynamic Movement Intervention (DMI) technique, specifically targeting improvements in neuromuscular development.
* Group B will receive therapy based on the Bobath approach, a conventional neurodevelopmental treatment method.
* Baseline assessments will be conducted by a blinded assessor prior to the initiation of intervention, followed by a second evaluation at the 6-week midpoint and a final assessment upon completion of the 12-week treatment period.
* Both interventions will be delivered over 12 weeks, with 3 sessions per week, each lasting approximately 40 minutes.
* Comparisons between the two groups will be made using pre- and post-test results to determine the relative efficacy of each intervention approach in improving gross motor function and trunk control.
Detailed Description:
1. Background \& Literature Review Cerebral palsy is one of the most common causes of motor disability in the pediatric population. It is defined as "a group of permanent disorders of the development of movement and posture, causing activity limitations that are attributed to non-progressive disturbances that occur in the developing fetal or infant brain."(1) The etiology of CP is multifactorial, with preterm birth and low birth weight identified as key risk factors. Data from European cohorts indicate that neonates weighing less than 1500 grams at birth have a 70-fold higher risk of developing CP compared to those with a birth weight greater than 2500 grams.(2) Spastic cerebral palsy, the most prevalent subtype, encompasses varying degrees of motor dysfunction depending on the extent and location of the brain lesion. Spastic diplegia, affecting 30-40% of individuals with CP, is characterized by bilateral lower limb involvement, spasticity, and impaired trunk control, resulting in persistent functional mobility limitations.(3) Clinical presentations vary, ranging from isolated motor impairments in cases of focal brain injury to more complex profiles involving sensory, cognitive, perceptual, communicative, and behavioral impairments in children with widespread brain pathology.(4) Recent meta-analyses indicate that the birth prevalence of cerebral palsy in high-income countries (HICs) has declined to 1.6 per 1,000 live births. In contrast, available data from low- and middle-income countries (LMICs) suggest a significantly higher prevalence, reaching up to 3.4 per 1,000 live births.(5) In Pakistan, a regional epidemiological study conducted in District Swabi, Khyber Pakhtunkhwa, reported a CP prevalence of 1.22 per 1000 live births, with a higher prevalence observed among males.(6) Beyond its clinical implications, CP imposes substantial economic burdens. The lifetime cost per individual is estimated at USD 862,762, encompassing direct healthcare expenditures, educational support services, and indirect costs related to loss of productivity.(7) Management of CP has evolved with a paradigm shift towards the International Classification of Functioning, Disability, and Health (ICF), which emphasizes enhancing functional capacity, minimizing activity limitations, and promoting participation across environments.(8) While early intervention has demonstrated benefits in cognitive development in preterm infants, its impact on long-term motor outcomes remains inconclusive, with gains often diminishing by school age.(9) Conventional approaches such as Neurodevelopmental Treatment (NDT), commonly known as the Bobath method, have historically focused on modulating tone and facilitating normative movement patterns.(10) However, systematic reviews have highlighted the limited empirical support for NDT, especially when compared with task-specific or goal-directed interventions. Novak et al. advocate for evidence-informed practices that yield meaningful, functional improvements and enhance quality of life.(11) Dynamic Movement Intervention (DMI) is a novel, task-oriented therapy that leverages principles of neuroplasticity. It involves structured, repetitive, and progressively challenging exercises designed to promote functional motor responses and support the acquisition of developmental milestones. Central to this approach is the repetition of activities across sessions until automaticity is achieved.(12) Given the proximal-to-distal sequence of motor development, trunk control is foundational for balance, coordinated limb movement, and functional mobility.(13) Trunk-specific interventions, particularly those performed on dynamic surfaces (e.g., therapy balls, wobble boards), have demonstrated superior efficacy in enhancing trunk muscle activation, postural control, and sensory integration compared to stable surfaces. Dynamic environments provide rich proprioceptive and vestibular input, facilitate adaptive motor responses, and contribute to improving balance and coordination.(14) Task-specific training, grounded in motor learning theory, involves repetitive practice of functional tasks. Empirical evidence underscores its effectiveness in improving motor performance, balance, and mobility in children with CP, especially when tasks are meaningful and practiced consistently.(15) This approach is believed to induce functional reorganization of motor pathways, resulting in sustainable improvements.(16) The therapeutic efficacy of dynamic surface exercises is attributed to three primary mechanisms: (i) vestibular feedback that modulates corrective postural responses based on head orientation deviations; (ii) proprioceptive input that informs body orientation relative to the support surface; and (iii) visual feedback that assists in stabilizing head and body position relative to the environment. These multimodal sensory systems synergistically facilitate postural adjustments and enhance trunk control.(12) A randomized controlled trial by Choi et al. (2023) investigated the efficacy of trunk-targeted NDT in children with spastic diplegic CP over 12 weeks. The intervention group demonstrated statistically significant improvements in gross motor function and trunk control, as measured by the Gross Motor Function Measure-88 (GMFM-88) and the Trunk Control Measurement Scale (TCMS), compared to conventional therapy.(17) In 2020, Reddy S and Balaji GK conducted a randomized controlled trial (RCT) and evaluated the effects of Dynamic Surface Exercise Training (DSET) in children with quadriplegic CP. Participants aged 4-12 underwent an 8-week DSET program incorporating unstable surface activities. Results indicated notable improvements in both gross motor function and trunk stability relative to conventional physiotherapy.(12) In 2023, a systematic review was conducted by Talgeri AJ, Nayak A et al. on the effect of trunk-targeted interventions on functional outcomes in children with cerebral palsy. Evidence supports that trunk-targeted interventions improve gross motor function, trunk control, and balance; hence should be incorporated in the conventional physical therapy program delivered to children with CP and would help in greater functional recovery.(18) In 2022, a systematic review and meta-analysis following the PRISMA guidelines with 1a level of evidence by Hotari, Sini-Pauliina et al assessed the effectiveness of physiotherapist-delivered task-oriented training on functional mobility and balance in children with cerebral palsy (CP). The results from the meta-analysis implicate a significant effect of task-oriented training in children with cerebral palsy when assessed in the Pediatric Balance Scale, Gross Motor Function Measure (GMFM) domains D \& E, and Timed Up \& Go test, when compared to other treatment methods used in the included trials. Improvements in functional mobility and balance in experimental and comparison groups were observed in all of the studies.(19) Despite growing interest in DMI, there is a paucity of randomized controlled trials directly comparing DMI to Bobath therapy in young children with spastic diplegic CP. Critically, the Trunk Impairment Scale (TIS)-a tool that explains up to 58% of variance in mobility-has seldom been employed as a primary outcome in such trials.(20)(21) Furthermore, there is an unmet need to establish age-specific, evidence-based protocols tailored to children aged 2-4 years within Gross Motor Function Classification System (GMFCS) levels I to III.
The present study aims to address these gaps by evaluating the comparative effectiveness of DMI and Bobath therapy on neuromuscular development in children with spastic diplegic CP. By utilizing validated outcome measures such as the GMFM-88, SSDT, and TIS, this study has the potential to inform clinical decision-making and refine early intervention paradigms in pediatric neurorehabilitation.
2. Problem Statement Spastic cerebral palsy (CP), particularly the diplegic subtype, represents one of the most prevalent pediatric neurological disorders, characterized by compromised motor function, impaired postural alignment, and deficient trunk control, ultimately hindering the attainment of functional mobility milestones. Conventional neurodevelopmental interventions, notably the Bobath approach, have long constituted a cornerstone of pediatric rehabilitation; however, emerging evidence has brought attention to innovative, task-oriented therapies such as Dynamic Movement Intervention (DMI). DMI emphasizes neuroplastic adaptation through structured, high-repetition, and intensity-based activities aimed at enhancing gross motor function and postural stability. Despite the theoretical and preliminary empirical support for DMI, there remains a paucity of rigorous comparative studies directly evaluating its clinical efficacy against traditional modalities like the Bobath technique. This lack of comparative evidence limits the ability of rehabilitation professionals to adopt evidence-informed treatment protocols. Consequently, there is a critical need for high-quality research that systematically examines and contrasts the therapeutic outcomes of DMI and Bobath approaches, particularly in terms of neuromuscular development, to inform clinical decision-making and optimize neuro-rehabilitative care for children with spastic cerebral palsy.
3. Research Objectives To compare the effects of DMI and Bobath approach on neuromuscular development in children with diplegic spastic CP.
4. Research Questions / Hypotheses
Research Questions:
* Does DMI improve neuromuscular development more effectively than Bobath therapy?
* What are the measurable outcomes of DMI after 12 weeks?
5. Hypothesis:
5.1. Null Hypothesis: There is no difference in the comparative effects of DMI and Bobath therapy on neuromuscular development in children with diplegic spastic CP.
5.2. Alternate Hypothesis: There is difference in the comparative effects of DMI and Bobath therapy on neuromuscular development in children with diplegic spastic CP.
6. Significance of the Study This study aims to generate robust evidence regarding the clinical utility of Dynamic Movement Intervention (DMI) in the rehabilitation of children with cerebral palsy (CP), thereby supporting clinicians in refining and individualizing therapeutic strategies. Enhancements in neuromuscular development, facilitated through effective intervention, have the potential to substantially improve the quality of life for children with CP by fostering greater independence and alleviating caregiver burden. Contemporary advances in pediatric neurorehabilitation underscore the efficacy of dynamic, task-specific interventions, particularly for children with diplegic or quadriplegic CP, where deficits in trunk stability markedly compromise functional performance. In contrast to traditional neurodevelopmental treatment (NDT), which primarily focuses on static postural alignment, emerging therapeutic paradigms emphasize active engagement in movement to facilitate neuromuscular adaptation and motor recovery. Supporting this perspective, Talgeri et al. (2023) conducted a comprehensive systematic review, concluding that trunk-targeted dynamic interventions confer superior improvements in gross motor function and trunk control compared to conventional static approaches, thus advocating for a paradigm shift in clinical practice.
7. Methodology 7.1. Research design
* Randomized Clinical Trial (RCT) 7.2. Study population and setting
* The target population includes children with spastic diplegic cerebral palsy aged between 2 to 4 years, exhibiting gross motor delays and impaired trunk control.
* The study will be conducted at a well-recognized rehabilitation center, Ghurki Trust Teaching Hospital, Lahore, Pakistan. This institution offers extensive pediatric neuro-rehabilitation services and ensures accessibility to the required pediatric population and intervention tools.
7.3. Sampling strategy and size Sampling technique
* Non-probability convenient sampling Randomization
* Randomization will be done using an online research randomizer tool (Computerized random number table) available at www.randomizer.org/. It requires information, including the number of groups and the sample size of the study.
Blinding
* Participants and outcome assessor will be blinded Sample size The sample size was calculated by G Power 3.1.9.7 software. Gross motor function measure (GMFM) between groups, posttest mean and standard deviation values of 81.21±16.83 and 70.97±14.99 were used with an effect size of 0.6365008. By using 80% power, the calculated sample size was 49. After including 20% attrition rate, the 58 patients will be recruited.(22) 7.4. Inclusion/Exclusion Criteria Inclusion Criteria
* Children aged 2-4 years.
* Diagnosed with spastic diplegic cerebral palsy.
* Gross Motor Function Measurement Scale (GMFC) level I to III.
* Children who have head control.
* Ability to understand and follow simple instructions.
Exclusion Criteria:
* Visual or hearing impairments (e.g., cataract, myopia, deafness).
* Cognitive problems impacting participation.
* Uncontrolled convulsions or recent seizure activity.
* Orthopedic surgeries of the lower limbs, such as dorsal rhizotomy within the last year.
7.5. Data collection tools
* GMFM-88
* Shoaib Sensorimotor Development tool (SSDT)
* Trunk Impairment Scale (TIS)
* CP-QOL-Child Questionnaire 7.5.1 The Gross Motor Function Measure (GMFM-88) It is a standardized observational assessment tool specifically developed to evaluate gross motor function in children with cerebral palsy and other conditions that impair motor performance. It is widely recognized for its clinical and research utility in tracking changes in motor abilities over time. The GMFM-88 consists of 88 items divided into five key dimensions of motor activity: Lying and Rolling (17 items), Sitting (20 items), Crawling and Kneeling (14 items), Standing (13 items), and Walking, Running, and Jumping (24 items).(23) Each item is scored using a 4-point ordinal scale, where 0 indicates that the child does not initiate the task, 1 indicates initiation of less than 10% of the task, 2 represents partial completion (10-99%), and 3 reflects complete execution of the task. Scores for each domain are converted into percentages, and a total score is calculated as the average of all dimensions. The GMFM-88 demonstrates high inter-rater reliability (Intraclass Correlation Coefficient = 0.97) and excellent test-retest reliability. It also possesses strong content, construct, and concurrent validity, making it a widely validated and trusted tool for assessing motor function in children aged 5 months to 16 years with cerebral palsy.(24) 7.5.2. Shoaib Sensorimotor Development tool (SSDT) The Shoaib Sensorimotor Development Tool is a clinical assessment instrument developed by Dr. Shoaib Waqas to evaluate sensorimotor development in children, particularly those with neurodevelopmental disorders such as cerebral palsy. The tool is designed to comprehensively assess various neuromotor components, including sensory integration, postural control, motor planning, coordination, and reflex activity. It is structured into multiple domains such as Gross motor development, Fine motor development, and social interaction, Tone, Balance, and Gait Development. Each item within these domains is scored based on the level of task completion. 0 indicates the child cannot do a task, while 0.5 indicates the child can do a task with assistance, and 1 indicates the child can do it without assistance. Preliminary studies have reported good internal consistency and inter-rater reliability, indicating its potential clinical utility. Content validity has been established through expert panel reviews.(25) 7.5.3 Trunk Impairment Scale (TIS) It is a standardized clinical assessment tool designed to evaluate motor impairment of the trunk, specifically focusing on static and dynamic sitting balance as well as trunk coordination. It is commonly used in individuals with neurological disorders such as stroke and cerebral palsy, where trunk control plays a critical role in postural stability and functional mobility. The scale is divided into three subscales: static sitting balance (maximum 7 points), dynamic sitting balance (maximum 10 points), and coordination (maximum 6 points), with a total possible score of 23. Higher scores indicate better trunk control and postural performance. The TIS has demonstrated excellent psychometric properties, with high inter-rater reliability (Intraclass Correlation Coefficient = 0.96) and strong intra-rater reliability. Its validity has also been well established, showing strong construct and discriminative validity across both adult and pediatric populations. It has been validated specifically for use in children with cerebral.(26)(27) 7.5.4 The Pediatric Quality of Life Inventory (PedsQL) It is a widely recognized and validated instrument designed to assess health-related quality of life (HRQoL) in children and adolescents aged 2 to 18 years. It evaluates four core domains of functioning: physical, emotional, social, and school functioning. The tool includes 23 items distributed across the following domains: Physical Functioning (8 items), Emotional Functioning (5 items), Social Functioning (5 items), and School Functioning (5 items). Each item is scored on a 5-point Likert scale, ranging from 0 (never a problem) to 4 (almost always a problem). The items are reverse-scored and linearly transformed to a 0-100 scale, where higher scores indicate better perceived quality of life. The tool has strong construct validity and discriminative capacity, having been validated in both general pediatric populations and children with chronic conditions, including cerebral palsy. It is applicable across all levels of the Gross Motor Function Classification System (GMFCS I-V).(28) 7.6. Data collection procedures
* Following the acquisition of informed consent, participants will be enrolled in the study based on the predetermined inclusion and exclusion criteria. Initial assessments will be conducted to establish baseline values. Participants will then be randomly allocated into two groups using a computer-generated method.
* Two treatment groups will be formed: Group A and Group B.
* Group A will receive intervention based on the Dynamic Movement Intervention (DMI) technique, specifically targeting improvements in neuromuscular development.
* Group B will receive therapy based on the Bobath approach, a conventional neurodevelopmental treatment method.
* Baseline assessments will be conducted by a blinded assessor prior to the initiation of intervention, followed by a second evaluation at the 6-week midpoint and a final assessment upon completion of the 12-week treatment period.
* Both interventions will be delivered over 12 weeks, with 3 sessions per week, each lasting approximately 40 minutes.
* Comparisons between the two groups will be made using pre- and post-test results to determine the relative efficacy of each intervention approach in improving gross motor function and trunk control.
7.7 Data analysis techniques
* Data analysis will be conducted using IBM SPSS Statistics version 26 for Windows. A significance level of p \< 0.05 will be considered statistically significant for all analyses. Descriptive statistics will be employed to summarize demographic and baseline characteristics of participants. Results will be presented using frequency tables, bar charts, and pie charts to provide a clear visual representation of the distribution of variables across the study groups and time points.
* For inferential statistics, the Shapiro-Wilk test will first be applied to assess the normality of the data. Appropriate statistical methods will be selected based on the normality test outcome. If the data is normally distributed, parametric tests (such as paired and independent t-tests) will be used for within-group and between-group comparisons, respectively. In the case of non-normal distribution, equivalent non-parametric tests (such as the Wilcoxon signed-rank test and Mann-Whitney U test) will be employed to analyze the differences.
7.8 Intervention Group A: Dynamic Movement Intervention (DMI) using task-specific, structured, repetitive, and progressively challenging dynamic exercises.
1. Rolling on a dynamic surface Goal: Facilitate trunk rotation, segmental control, and coordination between the upper and lower body
How to Perform:
* Use a soft therapy mat, an inflated air mattress, or a foam wedge as the dynamic surface.
* Place the child in supine position (lying on their back).
* The therapist gently guides the child to initiate rolling by encouraging them to turn the head, reach across midline with one arm, and bring the opposite leg over.
* Encourage segmental movement rather than a log roll to activate trunk muscles.
* Use visual or auditory cues (e.g., toys, sounds) to motivate movement.
* Progress to rolling from prone to supine and vice versa independently. Reps: 5-10 repetitions (depending on fatigue level), alternating sides.
2. Sitting:
How to Perform:
* Use a therapy ball, wobble cushion, or foam pad as the dynamic surface.
* The child sits upright with hips and knees at approximately 90°.
* Therapist ensures pelvis is in neutral alignment (no posterior tilt).
* Therapist applies gentle anterior-posterior and lateral perturbations to challenge balance.
* Child is encouraged to maintain an upright trunk using head and trunk righting responses.
* To progress: reach for objects in various directions or heights while maintaining sitting.
Reps: 3-5 sets of 1-2 minutes with brief rest between sets. 3. Trunk Stability (Quadruped, kneeling)
Crawling:
How to perform:
* Place a foam mat, balance beam with soft top, or unstable ramp on the floor.
* Child begins in quadruped position (hands and knees).
* The therapist facilitates movement by placing toys or targets ahead.
* Encourage the child to crawl forward, sideways, or over slightly uneven/dynamic surfaces.
* Increase challenge and repetitions gradually in a way that movement becomes automatic.
* Emphasize trunk rotation, alternating limb coordination, and proprioceptive feedback from limbs.
Reps: 3-4 trials per session with rest as needed.
Kneeling:
How to perform
* Child kneels on a foam surface, air cushion, or tumble form roll.
* Therapist supports pelvis if needed and encourages upright trunk posture.
* Child performs reaching activities to challenge balance (e.g., reaching across midline).
* Dynamic progression: shifting from tall kneeling to half-kneeling or kneeling-to-stand transitions.
Reps: 2-3 minutes of kneeling, repeated 3 times 4. Standing:
* Use a balance disc, BOSU ball (dome side up), or soft foam platform.
* Child stands with feet hip-width apart and knees slightly flexed.
* Therapist holds child at pelvis initially, progressing to minimal support.
* Ask child to perform small squats, weight shifts, or reach forward/sideways.
* Toys or visual stimuli can be added to make tasks goal-directed. Reps: 2-3 sets of 30-60 seconds, depending on endurance and response. 5. Walking:
* Use a soft foam mat, balance beam, tactile path, wooden boxes, and uneven surfaces to challenge walking.
* Begin with therapist-supported walking or holding onto a support rail.
* Encourage heel-to-toe walking, side-stepping, and multi-directional gait tasks to challenge different balance strategies.
* Incorporate variations such as:
* Walking while carrying a light object
* Stepping over small foam obstacles
* Walking with eyes on a visual target (to promote head-trunk coordination)
* Provide verbal feedback and manual cues as needed to maintain posture and step quality.
Reps: 3-5 walking trials per session, depending on endurance. Group B: Bobath Approach The Bobath approach focuses on facilitating normal movement patterns and improving postural control by inhibiting abnormal tone and promoting functional mobility.
In the early stages of development, rolling is facilitated by guiding the child's trunk and limbs to initiate segmental movements. The therapist encourages rolling by applying tactile input and assisting with weight shifting, helping the child dissociate the upper and lower body segments to achieve controlled trunk rotation.
For sitting, the child is initially supported in a stable seated position with proximal guidance at the pelvis or lower trunk. Through facilitation techniques, the therapist promotes upright alignment, midline orientation, and encourages reaching activities to develop dynamic balance and postural adjustments.
In crawling, the child is positioned in a quadruped posture, and the therapist provides hands-on facilitation at the pelvis and shoulders to guide coordinated limb movements. This enhances reciprocal motor patterns, weight shifting, and postural symmetry.
During kneeling activities, support is provided at the pelvis or trunk to help the child maintain a tall kneeling or half-kneeling position. The therapist may use toy placements to encourage reaching and activation of trunk stabilizers, improving proximal stability and preparing the child for transitions into standing. In standing, facilitation is provided to ensure proper foot alignment, symmetrical weight-bearing, and postural alignment. The child is supported at the hips or knees as needed, and weight-shifting activities are introduced to promote balance reactions and preparatory skills for gait.
In the standing phase, the Bobath approach emphasizes achieving upright posture through guided facilitation and alignment correction. The child is initially positioned in supported standing using external aids or therapist assistance, with key control at the pelvis, knees, or ankles to promote symmetrical weight-bearing and postural alignment. The therapist encourages active engagement of the lower limbs and trunk to maintain standing, dynamic weight shifts side-to-side or forward-backward to improve balance reactions and postural adjustments. Functional activities like reaching for toys placed at various heights are incorporated to make standing interactive and goal-oriented.
For walking, the Bobath approach involves hands-on facilitation to support proper gait patterns while minimizing abnormal synergies. The therapist provides support at the pelvis or trunk to guide stride initiation and facilitate reciprocal leg movements. Emphasis is placed on heel strike, knee extension, and toe-off phases to ensure functional gait cycles. Visual cues, toys, or auditory prompts are used to motivate forward stepping, and environmental adaptations such as parallel bars or a gait trainer may be introduced as needed. The approach prioritizes quality of movement, emphasizing efficient motor strategies and safety, rather than mere ambulation.
7.10 Ethical considerations Approval of the study has been obtained from the Institutional Review Board (IRB) to ensure adherence to ethical research standards. Additionally, institutional approval has also been granted by Ghurki Trust Teaching Hospital, the clinical setting where the intervention will be conducted. Before participation, informed written consent will be obtained from parents or legal guardians of all eligible children. They will be provided with comprehensive information about the study objectives, procedures, potential risks, and anticipated benefits to facilitate informed decision-making. Participant confidentiality will be strictly maintained throughout the research process. All personal and medical data will be securely stored and anonymized to protect privacy. The collected data will be used exclusively for academic and research purposes, and access will be restricted to the research team.
7.11 Limitations
* Despite careful planning, this study has some limitations. First, the use of a non-probability convenience sampling technique may introduce selection bias, limiting the generalizability of the findings to a broader population of children with spastic cerebral palsy.
* Variability in home support, compliance, and caregiver involvement might also influence the functional progress of participants and act as uncontrolled confounding factors.
8\. Expected Outcomes 8.1 Primary Outcome Measures
* Gross Motor Function Measure-88 (GMFM-88) A standardized observational tool used to assess changes in gross motor function across five dimensions, including lying, sitting, crawling, standing, and walking, specifically designed for children with cerebral palsy.
* Shoaib Sensorimotor Development Tool (SSDT) A specialized tool designed to assess sensorimotor development in children, including sensory integration, motor planning, and coordination. It provides insight into neuromotor function beyond gross motor skills.
* Trunk Impairment Scale (TIS) Evaluates trunk control through assessments of static sitting balance, dynamic sitting balance, and trunk coordination. It is essential for measuring core stability and postural control improvements.
8.2 Secondary Outcome Measure
• Cerebral Palsy Quality of Life Questionnaire for Children (CP QOL-Child) A validated caregiver-reported questionnaire that evaluates health-related quality of life in children with cerebral palsy. It covers emotional well-being, social participation, physical health, and overall life satisfaction.
The present study aims to address these gaps by evaluating the comparative effectiveness of DMI and Bobath therapy on neuromuscular development in children with spastic diplegic CP. By utilizing validated outcome measures such as the GMFM-88, SSDT, and TIS, this study has the potential to inform clinical decision-making and refine early intervention paradigms in pediatric neurorehabilitation.
2. Problem Statement Spastic cerebral palsy (CP), particularly the diplegic subtype, represents one of the most prevalent pediatric neurological disorders, characterized by compromised motor function, impaired postural alignment, and deficient trunk control, ultimately hindering the attainment of functional mobility milestones. Conventional neurodevelopmental interventions, notably the Bobath approach, have long constituted a cornerstone of pediatric rehabilitation; however, emerging evidence has brought attention to innovative, task-oriented therapies such as Dynamic Movement Intervention (DMI). DMI emphasizes neuroplastic adaptation through structured, high-repetition, and intensity-based activities aimed at enhancing gross motor function and postural stability. Despite the theoretical and preliminary empirical support for DMI, there remains a paucity of rigorous comparative studies directly evaluating its clinical efficacy against traditional modalities like the Bobath technique. This lack of comparative evidence limits the ability of rehabilitation professionals to adopt evidence-informed treatment protocols. Consequently, there is a critical need for high-quality research that systematically examines and contrasts the therapeutic outcomes of DMI and Bobath approaches, particularly in terms of neuromuscular development, to inform clinical decision-making and optimize neuro-rehabilitative care for children with spastic cerebral palsy.
3. Research Objectives To compare the effects of DMI and Bobath approach on neuromuscular development in children with diplegic spastic CP.
4. Research Questions / Hypotheses
Research Questions:
* Does DMI improve neuromuscular development more effectively than Bobath therapy?
* What are the measurable outcomes of DMI after 12 weeks?
5. Hypothesis:
5.1. Null Hypothesis: There is no difference in the comparative effects of DMI and Bobath therapy on neuromuscular development in children with diplegic spastic CP.
5.2. Alternate Hypothesis: There is difference in the comparative effects of DMI and Bobath therapy on neuromuscular development in children with diplegic spastic CP.
6. Significance of the Study This study aims to generate robust evidence regarding the clinical utility of Dynamic Movement Intervention (DMI) in the rehabilitation of children with cerebral palsy (CP), thereby supporting clinicians in refining and individualizing therapeutic strategies. Enhancements in neuromuscular development, facilitated through effective intervention, have the potential to substantially improve the quality of life for children with CP by fostering greater independence and alleviating caregiver burden. Contemporary advances in pediatric neurorehabilitation underscore the efficacy of dynamic, task-specific interventions, particularly for children with diplegic or quadriplegic CP, where deficits in trunk stability markedly compromise functional performance. In contrast to traditional neurodevelopmental treatment (NDT), which primarily focuses on static postural alignment, emerging therapeutic paradigms emphasize active engagement in movement to facilitate neuromuscular adaptation and motor recovery. Supporting this perspective, Talgeri et al. (2023) conducted a comprehensive systematic review, concluding that trunk-targeted dynamic interventions confer superior improvements in gross motor function and trunk control compared to conventional static approaches, thus advocating for a paradigm shift in clinical practice.
7. Methodology 7.1. Research design
* Randomized Clinical Trial (RCT) 7.2. Study population and setting
* The target population includes children with spastic diplegic cerebral palsy aged between 2 to 4 years, exhibiting gross motor delays and impaired trunk control.
* The study will be conducted at a well-recognized rehabilitation center, Ghurki Trust Teaching Hospital, Lahore, Pakistan. This institution offers extensive pediatric neuro-rehabilitation services and ensures accessibility to the required pediatric population and intervention tools.
7.3. Sampling strategy and size Sampling technique
* Non-probability convenient sampling Randomization
* Randomization will be done using an online research randomizer tool (Computerized random number table) available at www.randomizer.org/. It requires information, including the number of groups and the sample size of the study.
Blinding
* Participants and outcome assessor will be blinded Sample size The sample size was calculated by G Power 3.1.9.7 software. Gross motor function measure (GMFM) between groups, posttest mean and standard deviation values of 81.21±16.83 and 70.97±14.99 were used with an effect size of 0.6365008. By using 80% power, the calculated sample size was 49. After including 20% attrition rate, the 58 patients will be recruited.(22) 7.4. Inclusion/Exclusion Criteria Inclusion Criteria
* Children aged 2-4 years.
* Diagnosed with spastic diplegic cerebral palsy.
* Gross Motor Function Measurement Scale (GMFC) level I to III.
* Children who have head control.
* Ability to understand and follow simple instructions.
Exclusion Criteria:
* Visual or hearing impairments (e.g., cataract, myopia, deafness).
* Cognitive problems impacting participation.
* Uncontrolled convulsions or recent seizure activity.
* Orthopedic surgeries of the lower limbs, such as dorsal rhizotomy within the last year.
7.5. Data collection tools
* GMFM-88
* Shoaib Sensorimotor Development tool (SSDT)
* Trunk Impairment Scale (TIS)
* CP-QOL-Child Questionnaire 7.5.1 The Gross Motor Function Measure (GMFM-88) It is a standardized observational assessment tool specifically developed to evaluate gross motor function in children with cerebral palsy and other conditions that impair motor performance. It is widely recognized for its clinical and research utility in tracking changes in motor abilities over time. The GMFM-88 consists of 88 items divided into five key dimensions of motor activity: Lying and Rolling (17 items), Sitting (20 items), Crawling and Kneeling (14 items), Standing (13 items), and Walking, Running, and Jumping (24 items).(23) Each item is scored using a 4-point ordinal scale, where 0 indicates that the child does not initiate the task, 1 indicates initiation of less than 10% of the task, 2 represents partial completion (10-99%), and 3 reflects complete execution of the task. Scores for each domain are converted into percentages, and a total score is calculated as the average of all dimensions. The GMFM-88 demonstrates high inter-rater reliability (Intraclass Correlation Coefficient = 0.97) and excellent test-retest reliability. It also possesses strong content, construct, and concurrent validity, making it a widely validated and trusted tool for assessing motor function in children aged 5 months to 16 years with cerebral palsy.(24) 7.5.2. Shoaib Sensorimotor Development tool (SSDT) The Shoaib Sensorimotor Development Tool is a clinical assessment instrument developed by Dr. Shoaib Waqas to evaluate sensorimotor development in children, particularly those with neurodevelopmental disorders such as cerebral palsy. The tool is designed to comprehensively assess various neuromotor components, including sensory integration, postural control, motor planning, coordination, and reflex activity. It is structured into multiple domains such as Gross motor development, Fine motor development, and social interaction, Tone, Balance, and Gait Development. Each item within these domains is scored based on the level of task completion. 0 indicates the child cannot do a task, while 0.5 indicates the child can do a task with assistance, and 1 indicates the child can do it without assistance. Preliminary studies have reported good internal consistency and inter-rater reliability, indicating its potential clinical utility. Content validity has been established through expert panel reviews.(25) 7.5.3 Trunk Impairment Scale (TIS) It is a standardized clinical assessment tool designed to evaluate motor impairment of the trunk, specifically focusing on static and dynamic sitting balance as well as trunk coordination. It is commonly used in individuals with neurological disorders such as stroke and cerebral palsy, where trunk control plays a critical role in postural stability and functional mobility. The scale is divided into three subscales: static sitting balance (maximum 7 points), dynamic sitting balance (maximum 10 points), and coordination (maximum 6 points), with a total possible score of 23. Higher scores indicate better trunk control and postural performance. The TIS has demonstrated excellent psychometric properties, with high inter-rater reliability (Intraclass Correlation Coefficient = 0.96) and strong intra-rater reliability. Its validity has also been well established, showing strong construct and discriminative validity across both adult and pediatric populations. It has been validated specifically for use in children with cerebral.(26)(27) 7.5.4 The Pediatric Quality of Life Inventory (PedsQL) It is a widely recognized and validated instrument designed to assess health-related quality of life (HRQoL) in children and adolescents aged 2 to 18 years. It evaluates four core domains of functioning: physical, emotional, social, and school functioning. The tool includes 23 items distributed across the following domains: Physical Functioning (8 items), Emotional Functioning (5 items), Social Functioning (5 items), and School Functioning (5 items). Each item is scored on a 5-point Likert scale, ranging from 0 (never a problem) to 4 (almost always a problem). The items are reverse-scored and linearly transformed to a 0-100 scale, where higher scores indicate better perceived quality of life. The tool has strong construct validity and discriminative capacity, having been validated in both general pediatric populations and children with chronic conditions, including cerebral palsy. It is applicable across all levels of the Gross Motor Function Classification System (GMFCS I-V).(28) 7.6. Data collection procedures
* Following the acquisition of informed consent, participants will be enrolled in the study based on the predetermined inclusion and exclusion criteria. Initial assessments will be conducted to establish baseline values. Participants will then be randomly allocated into two groups using a computer-generated method.
* Two treatment groups will be formed: Group A and Group B.
* Group A will receive intervention based on the Dynamic Movement Intervention (DMI) technique, specifically targeting improvements in neuromuscular development.
* Group B will receive therapy based on the Bobath approach, a conventional neurodevelopmental treatment method.
* Baseline assessments will be conducted by a blinded assessor prior to the initiation of intervention, followed by a second evaluation at the 6-week midpoint and a final assessment upon completion of the 12-week treatment period.
* Both interventions will be delivered over 12 weeks, with 3 sessions per week, each lasting approximately 40 minutes.
* Comparisons between the two groups will be made using pre- and post-test results to determine the relative efficacy of each intervention approach in improving gross motor function and trunk control.
7.7 Data analysis techniques
* Data analysis will be conducted using IBM SPSS Statistics version 26 for Windows. A significance level of p \< 0.05 will be considered statistically significant for all analyses. Descriptive statistics will be employed to summarize demographic and baseline characteristics of participants. Results will be presented using frequency tables, bar charts, and pie charts to provide a clear visual representation of the distribution of variables across the study groups and time points.
* For inferential statistics, the Shapiro-Wilk test will first be applied to assess the normality of the data. Appropriate statistical methods will be selected based on the normality test outcome. If the data is normally distributed, parametric tests (such as paired and independent t-tests) will be used for within-group and between-group comparisons, respectively. In the case of non-normal distribution, equivalent non-parametric tests (such as the Wilcoxon signed-rank test and Mann-Whitney U test) will be employed to analyze the differences.
7.8 Intervention Group A: Dynamic Movement Intervention (DMI) using task-specific, structured, repetitive, and progressively challenging dynamic exercises.
1. Rolling on a dynamic surface Goal: Facilitate trunk rotation, segmental control, and coordination between the upper and lower body
How to Perform:
* Use a soft therapy mat, an inflated air mattress, or a foam wedge as the dynamic surface.
* Place the child in supine position (lying on their back).
* The therapist gently guides the child to initiate rolling by encouraging them to turn the head, reach across midline with one arm, and bring the opposite leg over.
* Encourage segmental movement rather than a log roll to activate trunk muscles.
* Use visual or auditory cues (e.g., toys, sounds) to motivate movement.
* Progress to rolling from prone to supine and vice versa independently. Reps: 5-10 repetitions (depending on fatigue level), alternating sides.
2. Sitting:
How to Perform:
* Use a therapy ball, wobble cushion, or foam pad as the dynamic surface.
* The child sits upright with hips and knees at approximately 90°.
* Therapist ensures pelvis is in neutral alignment (no posterior tilt).
* Therapist applies gentle anterior-posterior and lateral perturbations to challenge balance.
* Child is encouraged to maintain an upright trunk using head and trunk righting responses.
* To progress: reach for objects in various directions or heights while maintaining sitting.
Reps: 3-5 sets of 1-2 minutes with brief rest between sets. 3. Trunk Stability (Quadruped, kneeling)
Crawling:
How to perform:
* Place a foam mat, balance beam with soft top, or unstable ramp on the floor.
* Child begins in quadruped position (hands and knees).
* The therapist facilitates movement by placing toys or targets ahead.
* Encourage the child to crawl forward, sideways, or over slightly uneven/dynamic surfaces.
* Increase challenge and repetitions gradually in a way that movement becomes automatic.
* Emphasize trunk rotation, alternating limb coordination, and proprioceptive feedback from limbs.
Reps: 3-4 trials per session with rest as needed.
Kneeling:
How to perform
* Child kneels on a foam surface, air cushion, or tumble form roll.
* Therapist supports pelvis if needed and encourages upright trunk posture.
* Child performs reaching activities to challenge balance (e.g., reaching across midline).
* Dynamic progression: shifting from tall kneeling to half-kneeling or kneeling-to-stand transitions.
Reps: 2-3 minutes of kneeling, repeated 3 times 4. Standing:
* Use a balance disc, BOSU ball (dome side up), or soft foam platform.
* Child stands with feet hip-width apart and knees slightly flexed.
* Therapist holds child at pelvis initially, progressing to minimal support.
* Ask child to perform small squats, weight shifts, or reach forward/sideways.
* Toys or visual stimuli can be added to make tasks goal-directed. Reps: 2-3 sets of 30-60 seconds, depending on endurance and response. 5. Walking:
* Use a soft foam mat, balance beam, tactile path, wooden boxes, and uneven surfaces to challenge walking.
* Begin with therapist-supported walking or holding onto a support rail.
* Encourage heel-to-toe walking, side-stepping, and multi-directional gait tasks to challenge different balance strategies.
* Incorporate variations such as:
* Walking while carrying a light object
* Stepping over small foam obstacles
* Walking with eyes on a visual target (to promote head-trunk coordination)
* Provide verbal feedback and manual cues as needed to maintain posture and step quality.
Reps: 3-5 walking trials per session, depending on endurance. Group B: Bobath Approach The Bobath approach focuses on facilitating normal movement patterns and improving postural control by inhibiting abnormal tone and promoting functional mobility.
In the early stages of development, rolling is facilitated by guiding the child's trunk and limbs to initiate segmental movements. The therapist encourages rolling by applying tactile input and assisting with weight shifting, helping the child dissociate the upper and lower body segments to achieve controlled trunk rotation.
For sitting, the child is initially supported in a stable seated position with proximal guidance at the pelvis or lower trunk. Through facilitation techniques, the therapist promotes upright alignment, midline orientation, and encourages reaching activities to develop dynamic balance and postural adjustments.
In crawling, the child is positioned in a quadruped posture, and the therapist provides hands-on facilitation at the pelvis and shoulders to guide coordinated limb movements. This enhances reciprocal motor patterns, weight shifting, and postural symmetry.
During kneeling activities, support is provided at the pelvis or trunk to help the child maintain a tall kneeling or half-kneeling position. The therapist may use toy placements to encourage reaching and activation of trunk stabilizers, improving proximal stability and preparing the child for transitions into standing. In standing, facilitation is provided to ensure proper foot alignment, symmetrical weight-bearing, and postural alignment. The child is supported at the hips or knees as needed, and weight-shifting activities are introduced to promote balance reactions and preparatory skills for gait.
In the standing phase, the Bobath approach emphasizes achieving upright posture through guided facilitation and alignment correction. The child is initially positioned in supported standing using external aids or therapist assistance, with key control at the pelvis, knees, or ankles to promote symmetrical weight-bearing and postural alignment. The therapist encourages active engagement of the lower limbs and trunk to maintain standing, dynamic weight shifts side-to-side or forward-backward to improve balance reactions and postural adjustments. Functional activities like reaching for toys placed at various heights are incorporated to make standing interactive and goal-oriented.
For walking, the Bobath approach involves hands-on facilitation to support proper gait patterns while minimizing abnormal synergies. The therapist provides support at the pelvis or trunk to guide stride initiation and facilitate reciprocal leg movements. Emphasis is placed on heel strike, knee extension, and toe-off phases to ensure functional gait cycles. Visual cues, toys, or auditory prompts are used to motivate forward stepping, and environmental adaptations such as parallel bars or a gait trainer may be introduced as needed. The approach prioritizes quality of movement, emphasizing efficient motor strategies and safety, rather than mere ambulation.
7.10 Ethical considerations Approval of the study has been obtained from the Institutional Review Board (IRB) to ensure adherence to ethical research standards. Additionally, institutional approval has also been granted by Ghurki Trust Teaching Hospital, the clinical setting where the intervention will be conducted. Before participation, informed written consent will be obtained from parents or legal guardians of all eligible children. They will be provided with comprehensive information about the study objectives, procedures, potential risks, and anticipated benefits to facilitate informed decision-making. Participant confidentiality will be strictly maintained throughout the research process. All personal and medical data will be securely stored and anonymized to protect privacy. The collected data will be used exclusively for academic and research purposes, and access will be restricted to the research team.
7.11 Limitations
* Despite careful planning, this study has some limitations. First, the use of a non-probability convenience sampling technique may introduce selection bias, limiting the generalizability of the findings to a broader population of children with spastic cerebral palsy.
* Variability in home support, compliance, and caregiver involvement might also influence the functional progress of participants and act as uncontrolled confounding factors.
8\. Expected Outcomes 8.1 Primary Outcome Measures
* Gross Motor Function Measure-88 (GMFM-88) A standardized observational tool used to assess changes in gross motor function across five dimensions, including lying, sitting, crawling, standing, and walking, specifically designed for children with cerebral palsy.
* Shoaib Sensorimotor Development Tool (SSDT) A specialized tool designed to assess sensorimotor development in children, including sensory integration, motor planning, and coordination. It provides insight into neuromotor function beyond gross motor skills.
* Trunk Impairment Scale (TIS) Evaluates trunk control through assessments of static sitting balance, dynamic sitting balance, and trunk coordination. It is essential for measuring core stability and postural control improvements.
8.2 Secondary Outcome Measure
• Cerebral Palsy Quality of Life Questionnaire for Children (CP QOL-Child) A validated caregiver-reported questionnaire that evaluates health-related quality of life in children with cerebral palsy. It covers emotional well-being, social participation, physical health, and overall life satisfaction.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: