Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2025-12-29 @ 7:15 AM
Study NCT ID:
NCT07253857
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-23
First Post:
2025-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Hand and Arm Bimanual Intensive Therapy Including Lower Extremity in Spastic Cerebral Palsy
Sponsor:
Lahore University of Biological and Applied Sciences
Organization:
Study Overview
Official Title:
Effects of Hand and Arm Bimanual Intensive Therapy Including Lower Extremity on Motor Function and Cognition in Children With Spastic Cerebral Palsy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-12
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:
HABIT-ILE
Brief Summary:
Cerebral palsy (CP), particularly the spastic diplegic subtype, is characterized by motor impairments such as spasticity and mobility limitations. In addition to motor dysfunction, children with CP often experience cognitive impairments affecting decision-making, problem-solving, working memory, selective attention, and inhibitory control. These non-motor challenges contribute to reduced social interaction and quality of life.
Hand-Arm Bimanual Intensive Therapy Including Lower Extremity (HABIT-ILE) has demonstrated improvements in gross motor function among children with spastic CP. However, evidence regarding its impact on cognitive outcomes remains limited. This randomized controlled trial (RCT) aims to evaluate the effects of HABIT-ILE compared with conventional therapy on both motor and cognitive functions in children with spastic diplegic CP. By addressing both upper and lower limb the research seeks to provide a comprehensive therapeutic approach that may yield more significant developmental benefits. Ultimately, the findings could inform the interventions for improving outcomes in pediatric populations affected by diplegic cerebral palsy.
Participants will receive 90 hours of intervention, with assessments conducted at baseline, mid-intervention, and post-intervention. The study will investigate outcomes across motor domains and cognitive functions such as inhibitory control and working memory. Findings are expected to inform comprehensive therapeutic approaches to improve developmental outcomes and quality of life in pediatric populations affected by spastic diplegic CP.
Hand-Arm Bimanual Intensive Therapy Including Lower Extremity (HABIT-ILE) has demonstrated improvements in gross motor function among children with spastic CP. However, evidence regarding its impact on cognitive outcomes remains limited. This randomized controlled trial (RCT) aims to evaluate the effects of HABIT-ILE compared with conventional therapy on both motor and cognitive functions in children with spastic diplegic CP. By addressing both upper and lower limb the research seeks to provide a comprehensive therapeutic approach that may yield more significant developmental benefits. Ultimately, the findings could inform the interventions for improving outcomes in pediatric populations affected by diplegic cerebral palsy.
Participants will receive 90 hours of intervention, with assessments conducted at baseline, mid-intervention, and post-intervention. The study will investigate outcomes across motor domains and cognitive functions such as inhibitory control and working memory. Findings are expected to inform comprehensive therapeutic approaches to improve developmental outcomes and quality of life in pediatric populations affected by spastic diplegic CP.
Detailed Description:
Cerebral palsy is a group of permanent movement and posture disorder caused by damage to the developing brain typically before, during or after birth. It is one of the most common neurodevelopmental disorder in childhood. Spasticity accounts for the majority of cases (around 92%), followed by dyskinesia, hypotonia, ataxia, and mixed types. Within spastic CP, three subtypes are recognized: diplegia, quadriplegia, and hemiplegia. Spastic diplegia is defined by bilateral spasticity with greater involvement of the lower limbs than the upper limbs. It leads to the development of motor and non-motor impairments. The underlying pathology typically involves corticospinal tract damage occurring before, during, or shortly after birth, often linked to prematurity, hypoxic events, or neonatal infections. The motor functions limits functional independence in more extent that cognitive functions. The primary focus of cerebral palsy treatment has been on its motor impairments, particularly spasticity and mobility challenges. According to the recent evidence the individuals with spastic diplegia often experience cognitive impairments especially deficits in executive function. There is growing awareness about these cognitive impairments but interventions for managing executive dysfunction in cerebral palsy patients are still lacking.
The rehabilitation strategies for CP traditionally emphasize physical therapy approaches such as Bobath therapy, Rood's method and Task-oriented training. The task-oriented interventions focus on practicing real-life activities to improve functional independence. More recent evidence supports that activity based approaches such as constraint induced movement therapy and goal directed training, which have shown greater effectiveness than traditional neurodevelopmental therapy. These interventions often targets the specific areas such as upper limb function while neglecting broader impairments involving lower extremities and trunk coordination.
The intensive therapy, Hand-Arm Bimanual Intensive Therapy Including Lower Extremity (HABIT-ILE) was developed to address this limitation. HABIT-ILE integrates upper and lower limb training with trunk control in a structured rehabilitation program. It emphasizes playful, repetitive, and progressively shaped voluntary movements to enhance gross motor skills, postural control, and functional independence.
HABIT-ILE is a camp based intervention in which structured tasks are provided to the participants and the intensity of each task is progressed with time. The maximum of 8-12 participants is in included in one camp. Participants will be divided in 2 groups control group (n= 21) and intervention group (n=21) sample size consisting of 42 participants. The intervention will be provided for total of 90 hour for each group. As these children have limited attention span the typical 9 hour/day intervention is reduced to 3 hour/day for 6 weeks, 5 days a week for the intervention group. For the control group the intervention session will last for 1 hour in morning and 1 hour in evening home exercise plan per day for 9 weeks, 5 days a week.
The rehabilitation strategies for CP traditionally emphasize physical therapy approaches such as Bobath therapy, Rood's method and Task-oriented training. The task-oriented interventions focus on practicing real-life activities to improve functional independence. More recent evidence supports that activity based approaches such as constraint induced movement therapy and goal directed training, which have shown greater effectiveness than traditional neurodevelopmental therapy. These interventions often targets the specific areas such as upper limb function while neglecting broader impairments involving lower extremities and trunk coordination.
The intensive therapy, Hand-Arm Bimanual Intensive Therapy Including Lower Extremity (HABIT-ILE) was developed to address this limitation. HABIT-ILE integrates upper and lower limb training with trunk control in a structured rehabilitation program. It emphasizes playful, repetitive, and progressively shaped voluntary movements to enhance gross motor skills, postural control, and functional independence.
HABIT-ILE is a camp based intervention in which structured tasks are provided to the participants and the intensity of each task is progressed with time. The maximum of 8-12 participants is in included in one camp. Participants will be divided in 2 groups control group (n= 21) and intervention group (n=21) sample size consisting of 42 participants. The intervention will be provided for total of 90 hour for each group. As these children have limited attention span the typical 9 hour/day intervention is reduced to 3 hour/day for 6 weeks, 5 days a week for the intervention group. For the control group the intervention session will last for 1 hour in morning and 1 hour in evening home exercise plan per day for 9 weeks, 5 days a week.
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?: