Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2026-01-02 @ 9:24 AM
Study NCT ID:
NCT07134894
Status:
COMPLETED
Last Update Posted:
2025-08-21
First Post:
2025-08-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intensive Bimanual Therapy Versus Conventional Physical Therapy in Quadriplegic Cerebral Palsy
Sponsor:
University of Lahore
Organization:
Study Overview
Official Title:
Intensive Bimanual Therapy Versus Conventional Physical Therapy in Quadriplegic Cerebral Palsy
Status:
COMPLETED
Status Verified Date:
2025-08
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:
None
Brief Summary:
Quadriplegic cerebral palsy (CP) is a severe neurological condition affecting motor control in all four limbs, often resulting in profound functional limitations in daily activities. Impaired upper limb function restricts children's ability to perform essential self-care, educational, and play tasks. Intensive Bimanual Therapy (IBT) is a rehabilitation approach that engages both hands in coordinated, repetitive, and task-specific activities to promote motor learning and functional independence. Conventional Physical Therapy (CPT), while widely used, primarily targets gross motor skills and may not fully address complex bilateral coordination needs.
This randomized controlled trial is designed to compare the effects of IBT and CPT on upper limb function in children with quadriplegic CP. Thirty children aged 2-6 years, classified at Gross Motor Function Classification System (GMFCS) levels III-IV, will be randomly assigned to either CPT alone or a combination of CPT and IBT. The Able Hand Questionnaire (ABL) will be used to measure functional bimanual use before and after an 8-week intervention period. The study aims to determine whether IBT offers additional benefits over standard therapy in enhancing bimanual coordination and functional independence in this population.
This randomized controlled trial is designed to compare the effects of IBT and CPT on upper limb function in children with quadriplegic CP. Thirty children aged 2-6 years, classified at Gross Motor Function Classification System (GMFCS) levels III-IV, will be randomly assigned to either CPT alone or a combination of CPT and IBT. The Able Hand Questionnaire (ABL) will be used to measure functional bimanual use before and after an 8-week intervention period. The study aims to determine whether IBT offers additional benefits over standard therapy in enhancing bimanual coordination and functional independence in this population.
Detailed Description:
Cerebral palsy is a non-progressive neurodevelopmental disorder caused by early brain injury, with quadriplegic CP representing one of the most severe forms. Children with this condition experience marked impairments in voluntary motor control, coordination, and postural stability. Functional use of the upper limbs is often significantly reduced, which impacts participation in self-care, education, and social activities.
Conventional Physical Therapy (CPT) typically focuses on improving gross motor performance, range of motion, strength, and mobility. While effective for some functional domains, it may not adequately target bilateral coordination, which is critical for everyday tasks. Intensive Bimanual Therapy (IBT) emphasizes the simultaneous use of both hands in structured, progressive, and meaningful activities such as dressing, feeding, and object manipulation. The intervention is based on neuroplasticity principles, incorporating high-repetition, task-specific practice, and active engagement to enhance motor control.
This study will be conducted at the University of Lahore Teaching Hospital. Eligible participants will be children aged 2-6 years with a diagnosis of quadriplegic CP, classified at GMFCS levels III-IV, with sufficient cognitive ability to follow simple instructions. Exclusion criteria include joint contractures limiting bimanual tasks, recent upper limb surgery, botulinum toxin injections within six months, or poor compliance potential.
Participants will be randomly allocated into two groups:
Group A (CPT only): Three 40-minute sessions per week for 8 weeks, including upper limb range of motion exercises, strengthening, balance activities, and functional mobility tasks.
Group B (CPT + IBT): Three 60-minute sessions per week for 8 weeks, combining CPT with 30 minutes of structured bimanual activities. These activities will progress from simple grasping and object transfer tasks to more complex functional activities such as buttoning, puzzle assembly, water pouring, and feeding with utensils. Home-based practice will be encouraged with parental guidance.
The primary outcome measure will be the Able Hand Questionnaire (ABL), which assesses functional use of the hands in daily activities. Assessments will be performed at baseline and after the 8-week intervention by a blinded assessor. Statistical analysis will be performed using non-parametric methods appropriate for the data distribution.
This trial is designed to provide evidence on whether the integration of IBT into standard therapy protocols can optimize functional upper limb outcomes for children with quadriplegic CP, ultimately informing best-practice rehabilitation strategies.
Conventional Physical Therapy (CPT) typically focuses on improving gross motor performance, range of motion, strength, and mobility. While effective for some functional domains, it may not adequately target bilateral coordination, which is critical for everyday tasks. Intensive Bimanual Therapy (IBT) emphasizes the simultaneous use of both hands in structured, progressive, and meaningful activities such as dressing, feeding, and object manipulation. The intervention is based on neuroplasticity principles, incorporating high-repetition, task-specific practice, and active engagement to enhance motor control.
This study will be conducted at the University of Lahore Teaching Hospital. Eligible participants will be children aged 2-6 years with a diagnosis of quadriplegic CP, classified at GMFCS levels III-IV, with sufficient cognitive ability to follow simple instructions. Exclusion criteria include joint contractures limiting bimanual tasks, recent upper limb surgery, botulinum toxin injections within six months, or poor compliance potential.
Participants will be randomly allocated into two groups:
Group A (CPT only): Three 40-minute sessions per week for 8 weeks, including upper limb range of motion exercises, strengthening, balance activities, and functional mobility tasks.
Group B (CPT + IBT): Three 60-minute sessions per week for 8 weeks, combining CPT with 30 minutes of structured bimanual activities. These activities will progress from simple grasping and object transfer tasks to more complex functional activities such as buttoning, puzzle assembly, water pouring, and feeding with utensils. Home-based practice will be encouraged with parental guidance.
The primary outcome measure will be the Able Hand Questionnaire (ABL), which assesses functional use of the hands in daily activities. Assessments will be performed at baseline and after the 8-week intervention by a blinded assessor. Statistical analysis will be performed using non-parametric methods appropriate for the data distribution.
This trial is designed to provide evidence on whether the integration of IBT into standard therapy protocols can optimize functional upper limb outcomes for children with quadriplegic CP, ultimately informing best-practice rehabilitation strategies.
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?: