Intensive Bimanual Therapy Versus Conventional Physical Therapy in Quadriplegic Cerebral Palsy
- Conditions
- Quadriplegic Cerebral PalsyCerebral Palsy (CP)
- Registration Number
- NCT07134894
- Lead Sponsor
- University of Lahore
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- 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)
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in functional bimanual hand use as measured by the Able Hand Questionnaire (ABL) Baseline and 8 weeks post-intervention 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.
- Secondary Outcome Measures
Name Time Method Change in gross motor function classification (GMFCS level) Baseline and 8 weeks post-intervention The Gross Motor Function Classification System (GMFCS) is a standardized tool for classifying motor function in children with cerebral palsy, ranging from Level I (least severe) to Level V (most severe). Classification will be performed at baseline and at the end of the 8-week intervention by a trained physiotherapist to monitor any changes in functional mobility classification. Although large changes in GMFCS level over short intervention periods are rare, the measure provides context for interpreting functional gains.
Caregiver-reported independence in daily activities Baseline and 8 weeks post-intervention A structured caregiver questionnaire will be used to collect information on the child's ability to independently perform daily self-care tasks such as feeding, dressing, grooming, and play activities. The questionnaire will use a 3-point response scale (independent, requires assistance, dependent). This measure will be collected to assess perceived changes in independence associated with the intervention.
Adherence to home-based exercise program Throughout the 8-week intervention period Adherence will be monitored through weekly caregiver logs documenting completion of assigned home-based activities. The number of completed sessions will be compared to the total prescribed sessions to calculate adherence percentage. This will help determine feasibility and engagement with the home component of the program.
Trial Locations
- Locations (1)
The University of Lahore Teaching Hospital
🇵🇰Lahore, Pakistan
The University of Lahore Teaching Hospital🇵🇰Lahore, Pakistan