Quadriplegic Cerebral PalsyNCT07134894
Intensive Bimanual Therapy Versus Conventional Physical Therapy in Quadriplegic Cerebral Palsy
A study testing Intensive Bimanual Therapy plus Conventional Physical Therapy and Conventional Physical Therapy in people with Quadriplegic Cerebral Palsy and Cerebral Palsy (CP), run by University of Lahore at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 6 years
- Conditions the study is for
- Quadriplegic Cerebral Palsy, Cerebral Palsy (CP)
- What is being tested?
- Intensive Bimanual Therapy plus Conventional Physical Therapy and Conventional Physical Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Apr 2025to 11 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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)
- Being tested
- Intensive Bimanual Therapy plus Conventional Physical Therapy, Conventional Physical Therapy
- Keywords
- Cerebral Palsy, Quadriplegic CP, Conventional Physical Therapy, Bimanual Coordination, Intensive Bimanual Therapy, Neuroplasticity, Task-Specific Training
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive Bimanual Therapy plus Conventional Physical TherapyBehavioural
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 TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Conventional Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 8 weeks post-intervention
Secondary outcomes (3)
Change in gross motor function classification (GMFCS level)
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.
Measured: Baseline and 8 weeks post-intervention
Caregiver-reported independence in daily activities
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.
Measured: Baseline and 8 weeks post-intervention
Adherence to home-based exercise program
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.
Measured: Throughout the 8-week intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2025
- Study start15 Apr 2025
- Primary completion4 Aug 2025
- Study completion11 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quadriplegic Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by University of LahoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shareen Mehak, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07134894
- Sponsor's protocol ID
- UOL/IREB/25/09/0052
- Status last verified
- Aug 2025
- First submitted
- 14 Aug 2025
- Last updated
- 21 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Bimanual Therapy Versus Conventional Physical Therapy in Quadriplegic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT07134894
- Acronym / sponsor ID
- UOL/IREB/25/09/0052
- Conditions
- Quadriplegic Cerebral Palsy, Cerebral Palsy (CP)
- Keywords
- Cerebral Palsy, Quadriplegic CP, Conventional Physical Therapy, Bimanual Coordination, Intensive Bimanual Therapy, Neuroplasticity, Task-Specific Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- 4 Aug 2025 (actual)
- Study completion
- 11 Aug 2025 (actual)
- First posted
- 21 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive Bimanual Therapy plus Conventional Physical Therapy | Experimental | Behavioral: Intensive Bimanual Therapy plus Conventional Physical TherapyParticipants 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. |
| Conventional Physical Therapy Only | Active comparator | Behavioral: Conventional Physical TherapyParticipants 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. |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensive Bimanual Therapy plus Conventional Physical TherapyA 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. | Behavioural | Intensive Bimanual Therapy plus Conventional Physical Therapy |
| Conventional Physical TherapyA 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. | Behavioural | Conventional Physical Therapy Only |
Primary outcome
Change in functional bimanual hand use as measured by the Able Hand Questionnaire (ABL)
Time frame: 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.
3 secondary outcomes
Change in gross motor function classification (GMFCS level)
Time frame: Baseline and 8 weeks post-intervention
Caregiver-reported independence in daily activities
Time frame: Baseline and 8 weeks post-intervention
Adherence to home-based exercise program
Time frame: Throughout the 8-week intervention period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive Bimanual Therapy plus Conventional Physical Therapy and Conventional Physical Therapy in people with Quadriplegic Cerebral Palsy and Cerebral Palsy (CP), run by University of Lahore at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in functional bimanual hand use as measured by the Able Hand Questionnaire (ABL) (time frame: Baseline and 8 weeks post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2025.