Intensive Bimanual Therapy Versus Conventional Physical Therapy in Quadriplegic Cerebral Palsy

NCT07134894 | Completed DMC

• 1 other identifier: UOL/IREB/25/09/0052
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Quadriplegic Cerebral Palsy; Cerebral Palsy (CP)

Keywords

Cerebral Palsy; Quadriplegic CP; Conventional Physical Therapy; Bimanual Coordination; Intensive Bimanual Therapy; Neuroplasticity; Task-Specific Training

Outcome Measures

Primary Outcomes (1)

• Change in functional bimanual hand use as measured by the Able Hand Questionnaire (ABL)

  The Able Hand Questionnaire (ABL) is a validated assessment tool used to evaluate functional use of both hands in daily activities for children with motor impairments. It consists of 21 items, each scored on a 3-point scale (easy, difficult, impossible), with higher scores indicating greater functional ability. The measure will be administered by a blinded assessor at baseline and after the 8-week intervention period to determine the change in bimanual performance between groups.

  Baseline and 8 weeks post-intervention

Secondary Outcomes (3)

• Change in gross motor function classification (GMFCS level)

  Baseline and 8 weeks post-intervention

• Caregiver-reported independence in daily activities

  Baseline and 8 weeks post-intervention

• Adherence to home-based exercise program

  Throughout the 8-week intervention period

Study Arms (2)

Intensive Bimanual Therapy plus Conventional Physical Therapy

EXPERIMENTAL

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.

Behavioral: Intensive Bimanual Therapy plus Conventional Physical Therapy

Conventional Physical Therapy Only

ACTIVE COMPARATOR

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.

Behavioral: Conventional Physical Therapy

Interventions

Intensive Bimanual Therapy plus Conventional Physical Therapy 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.

Intensive Bimanual Therapy plus Conventional Physical Therapy

Conventional Physical Therapy 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.

Conventional Physical Therapy Only

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Lahore: lead

Study Sites (1)

The University of Lahore Teaching Hospital

Lahore, 54590, Pakistan

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Student

Study Record Dates

• First Submitted: August 14, 2025
• First Posted: August 21, 2025
• Study Start: April 15, 2025
• Primary Completion: August 4, 2025
• Study Completion: August 11, 2025
• Last Updated: August 21, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)