Intensive Bimanual Therapy Versus Conventional Physical Therapy in Quadriplegic Cerebral Palsy

NCT ID: NCT07134894

Last Updated: 2025-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-15
• Study Completion Date: 2025-08-11

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.

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.

Conditions

Quadriplegic Cerebral Palsy; Cerebral Palsy (CP)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intensive Bimanual Therapy plus Conventional Physical Therapy

Participants in this arm will receive a combination of Intensive Bimanual Therapy (IBT) and Conventional Physical Therapy (CPT) for 8 weeks. Therapy will be delivered three times per week, with two supervised sessions and one home-based session. Each 60-minute session will consist of 30 minutes of CPT-focusing on upper limb range of motion, strengthening, balance, and mobility-and 30 minutes of IBT, incorporating structured bimanual activities such as grasping, object transfer, buttoning, puzzle assembly, water pouring, and feeding with utensils. Activities will progress in complexity every two weeks, with parental guidance provided for home-based practice.

Group Type: EXPERIMENTAL

Intensive Bimanual Therapy plus Conventional Physical Therapy

Intervention Type: BEHAVIORAL

A combined rehabilitation program delivered over 8 weeks, three sessions per week. Each 60-minute session includes 30 minutes of Conventional Physical Therapy (CPT) to improve range of motion, muscle strength, balance, and gross motor function, and 30 minutes of Intensive Bimanual Therapy (IBT) to enhance bilateral hand coordination and functional independence. IBT tasks progress from basic grasping and object transfer to complex daily activities such as buttoning, puzzle assembly, water pouring, and feeding with utensils. Two sessions are supervised by a physiotherapist and one is completed at home under caregiver guidance.

Conventional Physical Therapy Only

Participants in this arm will receive Conventional Physical Therapy (CPT) for 8 weeks, delivered three times per week, with two supervised sessions and one home-based session. Each 40-minute session will include upper limb range of motion exercises, strengthening activities, and gross motor training, incorporating movements such as crawling, assisted stretches, squats, heel raises, step-ups, and knee lifts. Additional activities such as yoga-based poses, animal walks, single-leg stance, and stair climbing will be included to promote flexibility, balance, and functional mobility. The program focuses on general upper and lower limb conditioning without targeted bimanual coordination training.

Group Type: ACTIVE_COMPARATOR

Conventional Physical Therapy

Intervention Type: BEHAVIORAL

A standard physiotherapy program delivered over 8 weeks, three sessions per week, each lasting 40 minutes. Sessions focus on upper limb range of motion, strengthening, postural control, and functional mobility without targeted bimanual training. Exercises include assisted stretches, squats, heel raises, step-ups, knee lifts, yoga-based poses, animal walks, single-leg stance, and stair climbing to promote flexibility, balance, and gross motor performance. Two sessions are supervised by a physiotherapist and one is performed at home with caregiver supervision.

Interventions

Intensive Bimanual Therapy plus Conventional Physical Therapy

A combined rehabilitation program delivered over 8 weeks, three sessions per week. Each 60-minute session includes 30 minutes of Conventional Physical Therapy (CPT) to improve range of motion, muscle strength, balance, and gross motor function, and 30 minutes of Intensive Bimanual Therapy (IBT) to enhance bilateral hand coordination and functional independence. IBT tasks progress from basic grasping and object transfer to complex daily activities such as buttoning, puzzle assembly, water pouring, and feeding with utensils. Two sessions are supervised by a physiotherapist and one is completed at home under caregiver guidance.

Intervention Type: BEHAVIORAL

Conventional Physical Therapy

A standard physiotherapy program delivered over 8 weeks, three sessions per week, each lasting 40 minutes. Sessions focus on upper limb range of motion, strengthening, postural control, and functional mobility without targeted bimanual training. Exercises include assisted stretches, squats, heel raises, step-ups, knee lifts, yoga-based poses, animal walks, single-leg stance, and stair climbing to promote flexibility, balance, and gross motor performance. Two sessions are supervised by a physiotherapist and one is performed at home with caregiver supervision.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Children with quadriplegic cerebral palsy.(Te Velde et al., 2021)
• The target population consisted of children aged 2-6 years (Horwood et al., 2019)
• Classified as level 3 and 4 in the GMFCS (Sogbossi et al., 2021)
• Muscle tone grade 2 at modified Ashwarth scale.(Sogbossi et al., 2021)
• Sufficient cognitive function to follow simple instructions and physically able to engage in sitting and standing exercises. (Chaovalit et al., 2021)

Exclusion Criteria

• Joint contractures that interfere with bimanual tasks.
• History of upper limb orthopedic surgery
• Within the last half a year or botulinum toxin injections.
• Poor compliance with therapy.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Lahore

OTHER

Sponsor Role: lead

Responsible Party

Shareen Mehak

Student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The University of Lahore Teaching Hospital

Lahore, , Pakistan

Countries

Pakistan

Other Identifiers

UOL/IREB/25/09/0052

Identifier Type: -

Identifier Source: org_study_id