Cerebral PalsyNCT06658275
Comparison of Constraint-Induced Movement Therapy And Bimanual Intensive Therapy Through Tele-rehabilitation For CP
A study testing Constraint-induced movement therapy and Hand Arm Bimanual Intensive Training -HABIT in people with Cerebral Palsy, run by Riphah International University.
Trial summary
Cerebral palsy is a neurological condition affecting movement and posture, caused by non-progressive brain disruptions occurring during fetal development. Constraint-induced movement therapy (CIMT) significantly improves arm and hand function in children with hemiparetic cerebral palsy by using intensive therapy… Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Constraint-induced movement therapy and Hand Arm Bimanual Intensive Training -HABIT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- No sites listed yet
- Study dates
- Nov 2024to 30 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 6-12 years.
- Children with hemiplegic cerebral palsy with mild to moderate hand involvement.
- Ability to extend wrist \>20° and fingers at the metacarpophalangeal joints
- \>10° from full flexion
- Demonstrated ability to follow instructions during screening and complete the testing.
- Spasticity does not exceed a score of 1 or 1+ on the Modified Ashworth Scale
Who cannot join
- Health problems unassociated with CP.
- Visual problems interfering with treatment.
- Active or unstable seizures.
- Orthopedic surgery on the more affected hand within the last year.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison of Constraint-Induced Movement Therapy And Bimanual Intensive Therapy Through Tele-rehabilitation For Upper Limb Functions In Children With Hemiplegic Cerebral Palsy
Cerebral palsy is a neurological condition affecting movement and posture, caused by non-progressive brain disruptions occurring during fetal development. Constraint-induced movement therapy (CIMT) significantly improves arm and hand function in children with hemiparetic cerebral palsy by using intensive therapy sessions and restricting the unaffected limb to develop new motor skills. Bimanual therapy involves using both hands repeatedly to perform functional tasks, rather than relying on just one hand. Tele-rehabilitation (TR) is an affordable method of providing remote rehabilitation services through telecommunication technologies like smartphones and media applications. The aim of the study is to compare the effectiveness of CIMT and bimanual therapy delivered via tele-rehabilitation for improving upper limb function in children with cerebral palsy.
This randomized clinical trial will be conducted at Mubarik Medical Complex, Sargodha, Pakistan, with a sample size of 65. Participants will be randomly allocated into two groups using an online randomization tool, Group A will receive constraint-induced movement therapy (CIMT) intervention for 60 minutes, and Group B will receive bimanual therapy intervention for 60 minutes. Each participant will undergo treatment for three days a week on alternate days for eight weeks.
Spasticity will be assessed by using the Modified Ashworth Scale. The Quality of Upper Extremity Skills Test (QUEST) will evaluate dissociated movement, grasp, protective extension, and weight bearing, while the Tele-Rehabilitation Satisfaction Survey (TeSS) is designed to evaluate the experiences and satisfaction levels of patients or caregivers who have participated in tele-rehabilitation programs. Measurements will be taken at baseline, 4th week, 8th week, and at 12th week after discontinuation of treatment. The data will be entered and assessed using SPSS 26. For between-group analysis of parametric data, the independent t-test will be used, while non-parametric data will be analyzed using the Mann-Whitney test. Within-group comparisons will be conducted using repeated measures ANOVA for parametric data and Friedman ANOVA for non-parametric data.
- Conditions
- Cerebral Palsy
- Being tested
- Constraint-induced movement therapy, Hand Arm Bimanual Intensive Training -HABIT
- Keywords
- cerebral palsy, neurological disorder, physiotherapy techniques, movement disorder, muscle spasticity
- Medical subject headings
- Cerebral Palsy, Nervous System Diseases, Movement Disorders, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Constraint-induced movement therapyOther
During the first routine checkup, therapists will educate caregivers on how to perform the exercises and activities at home. Caregivers will place the childrens less-affected hands in slings and guide them through exercises designed to engage their weaker, paretic hands. The sling will be fastened around the childrens trunks, with the end securely closed.After the initial session, the intervention will be provided by the caregiver at home, with progress monitored by the therapist through Zoom meetings or WhatsApp video calls. Children will engage in play-based activities as part of the CIMT program to improve upper limb functions.These activities will include painting, pin the tail on the donkey for sensory awareness and proprioception, card games, bubble activities, squeezing sponges, building towers with blocks, playing a curtained box game, using tongs, and picking up coins. Exercises will be gradually progressed from easier to more challenging tasks as the child improves.
Hand Arm Bimanual Intensive Training -HABITOther
For the Bimanual Intensive Training group, a strategy similar to HABIT will be used. At the first routine checkup, therapists will educate caregivers on the exercises, which will then be conducted at home. Caregivers will guide children through specially designed bimanual activities without slings, focusing on tasks like reaching, grasping, manipulation, releasing, and bearing weight on the upper limb. Progress will be monitored remotely through Zoom or WhatsApp video calls.Exercises will include catching and throwing a ball to improve reaching, grasp, and release; squeezing a textured ball for sensory awareness and sustained grip; stabilising and reorienting paper while drawing and cutting to enhance forearm supination and wrist extension. Additional tasks like sticker peeling for pincer grip and dough playing for hand manipulation will also be included.Exercises will progress from easy to more difficult as the child improves
| Study group | Role | What they receive |
|---|---|---|
| GROUP A (Constraint-Induced Movement Therapy) | Experimental | Participants will undergo Constraint-Induced Movement Therapy(one hour), which will be administered by their parents under the guidance of a therapist through tele- rehabilitation for 3 days in a week for 8 weeks Receives: Other: Constraint-induced movement therapy |
| GROUP B (Bi-manual intensive therapy) | Experimental | Participants will undergo Bimanual therapy(one hour), which will be administered by their parents under the guidance of a therapist through tele-rehabilitation for 3 days in a week for 8 weeks. Receives: Other: Hand Arm Bimanual Intensive Training -HABIT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality Of Upper Extremity Skills Test (QUEST)
The Quality of Upper Extremity Skills Test (QUEST) was developed in 1991 specifically to address the needs of children with spastic cerebral palsy. It is a criterion-referenced assessment tool designed to measure the quality of upper limb movements. The test comprises 34 items, which are organized into four distinct domains. These domains collectively evaluate various aspects of upper extremity function. Administering and scoring the QUEST typically takes between 30 and 45 minutes.
Measured: 8 weeks
Telehealth Satisfaction Scale
The Telehealth Satisfaction Scale (TeSS) is a standardized tool designed to assess patient satisfaction with telehealth services. It evaluates aspects such as the quality of care, ease of use of telehealth technology, interaction with healthcare providers, and overall telehealth experience.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2024
- Study startNov 2024 (estimated)
- Primary completion30 Jul 2025 (estimated)
- Study completion30 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe 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
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Kashif, PhD-PT, Study chair, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06658275
- Sponsor's protocol ID
- REC/RCR&AHS/24/0234
- Status last verified
- Nov 2024
- First submitted
- 24 Oct 2024
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gorter JW, Rosenbaum PL, Hanna SE, Palisano RJ, Bartlett DJ, Russell DJ, Walter SD, Raina P, Galuppi BE, Wood E. Limb distribution, motor impairment, and functional classification of cerebral palsy. Dev Med Child Neurol. 2004 Jul;46(7):461-7. doi: 10.1017/s0012162204000763.
PubMed 15230459
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Constraint-Induced Movement Therapy And Bimanual Intensive Therapy Through Tele-rehabilitation For Upper Limb Functions In Children With Hemiplegic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06658275
- Acronym / sponsor ID
- REC/RCR&AHS/24/0234
- Conditions
- Cerebral Palsy
- Keywords
- cerebral palsy, neurological disorder, physiotherapy techniques, movement disorder, muscle spasticity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- Nov 2024 (estimated)
- Primary completion
- 30 Jul 2025 (estimated)
- Study completion
- 30 Jul 2025 (estimated)
- First posted
- 26 Oct 2024 (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.
Cerebral palsy is a neurological condition affecting movement and posture, caused by non-progressive brain disruptions occurring during fetal development. Constraint-induced movement therapy (CIMT) significantly improves arm and hand function in children with hemiparetic cerebral palsy by using intensive therapy sessions and restricting the unaffected limb to develop new motor skills. Bimanual therapy involves using both hands repeatedly to perform functional tasks, rather than relying on just one hand. Tele-rehabilitation (TR) is an affordable method of providing remote rehabilitation services through telecommunication technologies like smartphones and media applications. The aim of the study is to compare the effectiveness of CIMT and bimanual therapy delivered via tele-rehabilitation for improving upper limb function in children with cerebral palsy.
This randomized clinical trial will be conducted at Mubarik Medical Complex, Sargodha, Pakistan, with a sample size of 65. Participants will be randomly allocated into two groups using an online randomization tool, Group A will receive constraint-induced movement therapy (CIMT) intervention for 60 minutes, and Group B will receive bimanual therapy intervention for 60 minutes. Each participant will undergo treatment for three days a week on alternate days for eight weeks.
Spasticity will be assessed by using the Modified Ashworth Scale. The Quality of Upper Extremity Skills Test (QUEST) will evaluate dissociated movement, grasp, protective extension, and weight bearing, while the Tele-Rehabilitation Satisfaction Survey (TeSS) is designed to evaluate the experiences and satisfaction levels of patients or caregivers who have participated in tele-rehabilitation programs. Measurements will be taken at baseline, 4th week, 8th week, and at 12th week after discontinuation of treatment. The data will be entered and assessed using SPSS 26. For between-group analysis of parametric data, the independent t-test will be used, while non-parametric data will be analyzed using the Mann-Whitney test. Within-group comparisons will be conducted using repeated measures ANOVA for parametric data and Friedman ANOVA for non-parametric data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GROUP A (Constraint-Induced Movement Therapy) | Experimental | Other: Constraint-induced movement therapyParticipants will undergo Constraint-Induced Movement Therapy(one hour), which will be administered by their parents under the guidance of a therapist through tele- rehabilitation for 3 days in a week for 8 weeks |
| GROUP B (Bi-manual intensive therapy) | Experimental | Other: Hand Arm Bimanual Intensive Training -HABITParticipants will undergo Bimanual therapy(one hour), which will be administered by their parents under the guidance of a therapist through tele-rehabilitation for 3 days in a week for 8 weeks. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Age 6-12 years.
- Children with hemiplegic cerebral palsy with mild to moderate hand involvement.
- Ability to extend wrist \>20° and fingers at the metacarpophalangeal joints
- \>10° from full flexion
- Demonstrated ability to follow instructions during screening and complete the testing.
Key exclusion criteria (4 listed)
- Health problems unassociated with CP.
- Visual problems interfering with treatment.
- Active or unstable seizures.
- Orthopedic surgery on the more affected hand within the last year.
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 |
|---|---|---|
| Constraint-induced movement therapyDuring the first routine checkup, therapists will educate caregivers on how to perform the exercises and activities at home. Caregivers will place the childrens less-affected hands in slings and guide them through exercises designed to engage their weaker, paretic hands. The sling will be fastened around the childrens trunks, with the end securely closed.After the initial session, the intervention will be provided by the caregiver at home, with progress monitored by the therapist through Zoom meetings or WhatsApp video calls. Children will engage in play-based activities as part of the CIMT program to improve upper limb functions.These activities will include painting, pin the tail on the donkey for sensory awareness and proprioception, card games, bubble activities, squeezing sponges, building towers with blocks, playing a curtained box game, using tongs, and picking up coins. Exercises will be gradually progressed from easier to more challenging tasks as the child improves. | Other | GROUP A (Constraint-Induced Movement Therapy) |
| Hand Arm Bimanual Intensive Training -HABITFor the Bimanual Intensive Training group, a strategy similar to HABIT will be used. At the first routine checkup, therapists will educate caregivers on the exercises, which will then be conducted at home. Caregivers will guide children through specially designed bimanual activities without slings, focusing on tasks like reaching, grasping, manipulation, releasing, and bearing weight on the upper limb. Progress will be monitored remotely through Zoom or WhatsApp video calls.Exercises will include catching and throwing a ball to improve reaching, grasp, and release; squeezing a textured ball for sensory awareness and sustained grip; stabilising and reorienting paper while drawing and cutting to enhance forearm supination and wrist extension. Additional tasks like sticker peeling for pincer grip and dough playing for hand manipulation will also be included.Exercises will progress from easy to more difficult as the child improves | Other | GROUP B (Bi-manual intensive therapy) |
Primary outcome
Quality Of Upper Extremity Skills Test (QUEST)
Time frame: 8 weeks
The Quality of Upper Extremity Skills Test (QUEST) was developed in 1991 specifically to address the needs of children with spastic cerebral palsy. It is a criterion-referenced assessment tool designed to measure the quality of upper limb movements. The test comprises 34 items, which are organized into four distinct domains. These domains collectively evaluate various aspects of upper extremity function. Administering and scoring the QUEST typically takes between 30 and 45 minutes.
Telehealth Satisfaction Scale
Time frame: 8 weeks
The Telehealth Satisfaction Scale (TeSS) is a standardized tool designed to assess patient satisfaction with telehealth services. It evaluates aspects such as the quality of care, ease of use of telehealth technology, interaction with healthcare providers, and overall telehealth experience.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
- Background: PubMed 15230459Gorter JW, Rosenbaum PL, Hanna SE, Palisano RJ, Bartlett DJ, Russell DJ, Walter SD, Raina P, Galuppi BE, Wood E. Limb distribution, motor impairment, and functional classification of cerebral palsy. Dev Med Child Neurol. 2004 Jul;46(7):461-7. doi: 10.1017/s0012162204000763.
- 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.
Muhammad Kashif, PhD-PT study chair
Riphah International University
Questions about this trial
What is this clinical trial studying?
A study testing Constraint-induced movement therapy and Hand Arm Bimanual Intensive Training -HABIT in people with Cerebral Palsy, run by Riphah International University.
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 6 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: opening soon, as of the sponsor's last update on 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Muhammad Kashif, PhD-PT (+923333125303, kashif.shaffi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality Of Upper Extremity Skills Test (QUEST) (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06658275, which also lists 1 linked publication.
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 22 Nov 2024.