Spastic Cerebral Palsy (sCP)BUST-CPNCT07437274
Bimanual Training Versus Unilateral Task Specific Training in Children With Spastic Hemiplegic Cerebral Palsy
A study testing Bimanual Training and Unilateral Task-Specific Training in people with Spastic Cerebral Palsy (sCP), run by Montiha Azeem at 1 site in Pakistan.
Trial summary
Cerebral palsy is one of the most common childhood neurological disorders and often results in weakness, poor coordination, and stiffness (spasticity) in one side of the body in children with spastic hemiplegic cerebral palsy. Read more about this study
- Who is it for?
- Ages 5 to 15 years
- Conditions the study is for
- Spastic Cerebral Palsy (sCP)
- What is being tested?
- Bimanual Training and Unilateral Task-Specific Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2026to 2 May 2026
- 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 5 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Both male and female Children diagnosed with spastic hemiplegic cerebral palsy (confirmed by a pediatric neurologist or rehabilitation specialist).
- Age range: 5 to 12 years (suitable for both bimanual and unilateral task-specific training).
- Gross Motor Function Classification System (GMFCS) levels I to III (ambulatory with or without limitations).
- Modified Ashworth Scale score between 1 and 3 in the upper limb muscles (indicating mild to moderate spasticity).
- Minimum cognitive ability to follow simple instructions, verified using screening tools (e.g., MMSE adapted for children).
- Ability to sit unsupported for at least 30 seconds (to ensure safe participation in therapy).
Who cannot join
- Children with mixed types of cerebral palsy (e.g., spastic quadriplegia, dyskinetic, or ataxic types).
- Recent orthopedic surgery or botulinum toxin injections in the affected upper limb within the past 6 months.
- Severe visual, auditory, or sensory deficits that could interfere with therapy participation or assessment accuracy.
- Uncontrolled epilepsy or other neurological conditions that could compromise safety during therapy.
- Fixed joint contractures or severe deformities in the upper limbs that limit passive range of motion Children with behavioral or psychological disorders (e.g., severe ADHD, autism spectrum disorder) that impair attention or participation
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
University of Lahore Teaching Hospital, Lahore
Lahore, Punjab Province, 54000
About this study
Cerebral palsy is one of the most common childhood neurological disorders and often results in weakness, poor coordination, and stiffness (spasticity) in one side of the body in children with spastic hemiplegic cerebral palsy. These difficulties can significantly affect a child's ability to perform daily activities such as dressing, eating, playing, and school-related tasks.
Upper limb rehabilitation plays a crucial role in improving independence and quality of life in these children. Two commonly used rehabilitation approaches are bimanual training, which focuses on using both hands together during functional tasks, and unilateral task-specific training, which focuses intensively on improving the affected hand through repetitive, goal-directed activities.
Read more
Although both approaches are widely practiced in pediatric neurorehabilitation, there is limited direct comparison of their effectiveness in reducing spasticity and improving functional independence among children with spastic hemiplegic cerebral palsy, particularly in the local population of Pakistan.
This randomized controlled trial aims to compare the effectiveness of bimanual training versus unilateral task-specific training in children aged 5-12 years diagnosed with spastic hemiplegic cerebral palsy. A total of 46 participants will be randomly assigned to one of two intervention groups. Both groups will receive therapy three times per week for eight weeks.
Spasticity will be measured using the Modified Ashworth Scale (MAS), and functional independence will be assessed using the Pediatric Evaluation of Disability Inventory (PEDI). Assessments will be conducted before and after the intervention period.
The results of this study may help clinicians, caregivers, and rehabilitation centers determine which therapy approach is more effective in improving upper limb function and independence in children with spastic hemiplegic cerebral palsy. Participation in this study is voluntary, and children may withdraw at any time without affecting their standard care.
Read the detailed description
Study Design
This study is a randomized controlled trial (RCT) designed to compare the effectiveness of bimanual training and unilateral task-specific training on spasticity and functional independence in children with spastic hemiplegic cerebral palsy.
Study Setting and Duration
Data will be collected from Sukkur Institute of Nursing and Allied Health Sciences, Blood Bank Hospital Sukkur, and Hidayat Physiotherapy and Rehabilitation Center. The study duration will be nine months following approval of the synopsis.
Sample Size
The calculated sample size is 46 participants, including a 20% anticipated dropout rate. The sample size was determined using the formula for comparing two means with a 95% confidence interval and 80% power. The final estimated sample includes 19 participants per group (38 total), adjusted to 46 to accommodate potential attrition.
Sampling Technique and Randomization
Participants will be recruited using a non-probability convenient sampling technique. After enrollment, children will be randomly assigned into two groups (Group A and Group B) using the sealed envelope method to ensure allocation concealment.
Selection Criteria Inclusion Criteria
Children aged 5-12 years diagnosed with spastic hemiplegic cerebral palsy.
GMFCS levels I-III.
Modified Ashworth Scale score between 1 and 3 in upper limb muscles.
Ability to follow simple instructions.
Ability to sit unsupported for at least 30 seconds.
Exclusion Criteria
Mixed types of cerebral palsy.
Recent orthopedic surgery or botulinum toxin injection within 6 months.
Severe sensory deficits.
Uncontrolled epilepsy.
Fixed contractures in the upper limb.
Severe behavioral or psychological disorders affecting participation.
Operational Definitions Spasticity
Spasticity is defined as a velocity-dependent increase in muscle tone resulting from hyperexcitability of the stretch reflex. It will be measured using the Modified Ashworth Scale (MAS), graded from 0 to 4, with higher scores indicating greater spasticity.
Functional Independence
Functional independence is defined as the child's ability to perform age-appropriate daily activities without physical assistance. It will be measured using the Pediatric Evaluation of Disability Inventory (PEDI), covering self-care, mobility, and social function domains.
Interventions Group A - Bimanual Training
Participants will receive structured bimanual training focused on improving coordinated use of both hands during functional tasks. Therapy will be delivered 3 sessions per week for 8 weeks, each session lasting 60 minutes. Activities will include buttoning, folding clothes, opening containers, block building, and bilateral play tasks. Sessions will be divided into three 20-minute blocks with 5-minute rest intervals.
Group B - Unilateral Task-Specific Training
Participants will receive unilateral task-specific training targeting the affected upper limb. Therapy will be delivered 3 sessions per week for 8 weeks, each session lasting 60 minutes. Activities will include grasp-and-release, reaching, stacking, drawing, card flipping, and object manipulation. The unaffected hand may be mildly restrained when necessary to encourage use of the affected limb.
Baseline Treatment
Both groups will receive standardized baseline physiotherapy education, including passive range-of-motion exercises, stretching, spasticity management techniques, and postural guidance. A home exercise booklet will be provided to caregivers.
Data Collection Procedure
Baseline assessments will be conducted before intervention. Post-intervention assessments will be performed after 8 weeks by blinded assessors to ensure objectivity. Data will be recorded on structured forms and securely stored for analysis.
Ethical Considerations
The study will be conducted according to the Declaration of Helsinki and institutional ethical guidelines. Written informed consent will be obtained from parents or guardians. Participation will be voluntary, and confidentiality will be strictly maintained. Participants may withdraw at any time without affecting their standard care.
- Conditions
- Spastic Cerebral Palsy (sCP)
- Being tested
- Bimanual Training, Unilateral Task-Specific Training
- Keywords
- Bimanual Training, Unilateral Task-Specific Training, Pediatric Neurorehabilitation, Functional Independence
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bimanual TrainingBehavioural
Bimanual training is a structured, task-oriented upper limb rehabilitation program designed to promote coordinated use of both hands during functional, goal-directed activities. The intervention emphasizes active involvement of the affected upper limb within bilateral tasks rather than isolating it. Therapy will be delivered three sessions per week for 8 weeks, with each session lasting 60 minutes.
Each session will consist of three 20-minute activity blocks with 5-minute rest intervals to reduce fatigue. Activities will include age-appropriate, real-life bilateral tasks such as buttoning shirts, folding clothes, opening containers, building with blocks, drawing with both hands, catching and throwing balls, and interactive bimanual play tasks. Task complexity will be progressively increased based on the child's tolerance and performance.
Unlike unilateral training, this approach focuses on improving interlimb coordination, motor planning, and functional integration of both upper limb
Unilateral Task-Specific TrainingBehavioural
Unilateral Task-Specific Training
| Study group | Role | What they receive |
|---|---|---|
| group A Bimanual Training Group | Experimental | Participants in this group will receive structured bimanual training designed to improve coordination, reduce spasticity, and enhance functional use of both upper limbs. The intervention will be delivered three sessions per week for 8 weeks, with each session lasting 60 minutes. Activities will include repetitive, goal-directed bilateral tasks such as buttoning shirts, folding clothes, opening containers, building with blocks, and bimanual play activities. Each session will be divided into three 20-minute activity blocks with 5-minute rest intervals to prevent fatigue. All sessions will be supervised by a certified pediatric physiotherapist trained in neurorehabilitation. In addition, participants will receive standardized baseline physiotherapy education at the start of the study. Receives: Behavioral: Bimanual Training |
| group B Unilateral Task-Specific Training Group | Active comparator | Participants in this group will receive unilateral task-specific training focused on intensive use of the affected upper limb to promote neuroplasticity and functional recovery. The intervention will be delivered three sessions per week for 8 weeks, with each session lasting 60 minutes. Activities will include grasp-and-release exercises, reaching, stacking, drawing, flipping cards, and manipulation of objects using the affected hand. The unaffected hand may be mildly restrained when necessary to encourage active use of the affected limb without causing frustration. Sessions will be structured into three 20-minute blocks with 5-minute rest intervals. Standardized baseline physiotherapy education will also be provided at the beginning of the study. Receives: Behavioral: Unilateral Task-Specific Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Upper Limb Spasticity Measured by Modified Ashworth Scale (MAS)
Spasticity will be assessed using the Modified Ashworth Scale (MAS), a standardized clinical tool used to measure velocity-dependent resistance to passive muscle stretch. The MAS grades muscle tone on a scale from 0 to 4, with higher scores indicating greater spasticity. Upper limb muscle groups (including elbow flexors, wrist flexors, and finger flexors) will be evaluated by trained physiotherapists. The primary outcome will be the change in MAS score from baseline to post-intervention, comparing the effectiveness of bimanual training versus unilateral task-specific training in reducing spasticity.
Measured: Baseline (Week 0) mid week(4), Post-intervention (Week 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start1 Mar 2026
- Primary completion1 Mar 2026
- Study completion2 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spastic Cerebral Palsy (sCP)Studies of the same condition, open and under way.
- 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
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montiha Azeem
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Montiha Azeem, University of Lahore
- Investigators
- Muhammad Hasnain Soomro, MSPTN, Principal investigator, The University of Lahore, Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07437274
- Sponsor's protocol ID
- UOL/IREB/25/15/03/13
- Acronym
- BUST-CP
- Status last verified
- Feb 2026
- First submitted
- 20 Feb 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bimanual Training Versus Unilateral Task Specific Training in Children With Spastic Hemiplegic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT07437274
- Acronym / sponsor ID
- BUST-CP / UOL/IREB/25/15/03/13
- Conditions
- Spastic Cerebral Palsy (sCP)
- Keywords
- Bimanual Training, Unilateral Task-Specific Training, Pediatric Neurorehabilitation, Functional Independence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Montiha AzeemUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 2 May 2026 (actual)
- First posted
- 27 Feb 2026 (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 one of the most common childhood neurological disorders and often results in weakness, poor coordination, and stiffness (spasticity) in one side of the body in children with spastic hemiplegic cerebral palsy. These difficulties can significantly affect a child's ability to perform daily activities such as dressing, eating, playing, and school-related tasks.
Upper limb rehabilitation plays a crucial role in improving independence and quality of life in these children. Two commonly used rehabilitation approaches are bimanual training, which focuses on using both hands together during functional tasks, and unilateral task-specific training, which focuses intensively on improving the affected hand through repetitive, goal-directed activities.
Although both approaches are widely practiced in pediatric neurorehabilitation, there is limited direct comparison of their effectiveness in reducing spasticity and improving functional independence among children with spastic hemiplegic cerebral palsy, particularly in the local population of Pakistan.
This randomized controlled trial aims to compare the effectiveness of bimanual training versus unilateral task-specific training in children aged 5-12 years diagnosed with spastic hemiplegic cerebral palsy. A total of 46 participants will be randomly assigned to one of two intervention groups. Both groups will receive therapy three times per week for eight weeks.
Spasticity will be measured using the Modified Ashworth Scale (MAS), and functional independence will be assessed using the Pediatric Evaluation of Disability Inventory (PEDI). Assessments will be conducted before and after the intervention period.
The results of this study may help clinicians, caregivers, and rehabilitation centers determine which therapy approach is more effective in improving upper limb function and independence in children with spastic hemiplegic cerebral palsy. Participation in this study is voluntary, and children may withdraw at any time without affecting their standard care.
Detailed description
Study Design
This study is a randomized controlled trial (RCT) designed to compare the effectiveness of bimanual training and unilateral task-specific training on spasticity and functional independence in children with spastic hemiplegic cerebral palsy.
Study Setting and Duration
Data will be collected from Sukkur Institute of Nursing and Allied Health Sciences, Blood Bank Hospital Sukkur, and Hidayat Physiotherapy and Rehabilitation Center. The study duration will be nine months following approval of the synopsis.
Sample Size
The calculated sample size is 46 participants, including a 20% anticipated dropout rate. The sample size was determined using the formula for comparing two means with a 95% confidence interval and 80% power. The final estimated sample includes 19 participants per group (38 total), adjusted to 46 to accommodate potential attrition.
Sampling Technique and Randomization
Participants will be recruited using a non-probability convenient sampling technique. After enrollment, children will be randomly assigned into two groups (Group A and Group B) using the sealed envelope method to ensure allocation concealment.
Selection Criteria Inclusion Criteria
Children aged 5-12 years diagnosed with spastic hemiplegic cerebral palsy.
GMFCS levels I-III.
Modified Ashworth Scale score between 1 and 3 in upper limb muscles.
Ability to follow simple instructions.
Ability to sit unsupported for at least 30 seconds.
Exclusion Criteria
Mixed types of cerebral palsy.
Recent orthopedic surgery or botulinum toxin injection within 6 months.
Severe sensory deficits.
Uncontrolled epilepsy.
Fixed contractures in the upper limb.
Severe behavioral or psychological disorders affecting participation.
Operational Definitions Spasticity
Spasticity is defined as a velocity-dependent increase in muscle tone resulting from hyperexcitability of the stretch reflex. It will be measured using the Modified Ashworth Scale (MAS), graded from 0 to 4, with higher scores indicating greater spasticity.
Functional Independence
Functional independence is defined as the child's ability to perform age-appropriate daily activities without physical assistance. It will be measured using the Pediatric Evaluation of Disability Inventory (PEDI), covering self-care, mobility, and social function domains.
Interventions Group A - Bimanual Training
Participants will receive structured bimanual training focused on improving coordinated use of both hands during functional tasks. Therapy will be delivered 3 sessions per week for 8 weeks, each session lasting 60 minutes. Activities will include buttoning, folding clothes, opening containers, block building, and bilateral play tasks. Sessions will be divided into three 20-minute blocks with 5-minute rest intervals.
Group B - Unilateral Task-Specific Training
Participants will receive unilateral task-specific training targeting the affected upper limb. Therapy will be delivered 3 sessions per week for 8 weeks, each session lasting 60 minutes. Activities will include grasp-and-release, reaching, stacking, drawing, card flipping, and object manipulation. The unaffected hand may be mildly restrained when necessary to encourage use of the affected limb.
Baseline Treatment
Both groups will receive standardized baseline physiotherapy education, including passive range-of-motion exercises, stretching, spasticity management techniques, and postural guidance. A home exercise booklet will be provided to caregivers.
Data Collection Procedure
Baseline assessments will be conducted before intervention. Post-intervention assessments will be performed after 8 weeks by blinded assessors to ensure objectivity. Data will be recorded on structured forms and securely stored for analysis.
Ethical Considerations
The study will be conducted according to the Declaration of Helsinki and institutional ethical guidelines. Written informed consent will be obtained from parents or guardians. Participation will be voluntary, and confidentiality will be strictly maintained. Participants may withdraw at any time without affecting their standard care.
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 Bimanual Training Group | Experimental | Behavioral: Bimanual TrainingParticipants in this group will receive structured bimanual training designed to improve coordination, reduce spasticity, and enhance functional use of both upper limbs. The intervention will be delivered three sessions per week for 8 weeks, with each session lasting 60 minutes. Activities will include repetitive, goal-directed bilateral tasks such as buttoning shirts, folding clothes, opening containers, building with blocks, and bimanual play activities. Each session will be divided into three 20-minute activity blocks with 5-minute rest intervals to prevent fatigue. All sessions will be supervised by a certified pediatric physiotherapist trained in neurorehabilitation. In addition, participants will receive standardized baseline physiotherapy education at the start of the study. |
| group B Unilateral Task-Specific Training Group | Active comparator | Behavioral: Unilateral Task-Specific TrainingParticipants in this group will receive unilateral task-specific training focused on intensive use of the affected upper limb to promote neuroplasticity and functional recovery. The intervention will be delivered three sessions per week for 8 weeks, with each session lasting 60 minutes. Activities will include grasp-and-release exercises, reaching, stacking, drawing, flipping cards, and manipulation of objects using the affected hand. The unaffected hand may be mildly restrained when necessary to encourage active use of the affected limb without causing frustration. Sessions will be structured into three 20-minute blocks with 5-minute rest intervals. Standardized baseline physiotherapy education will also be provided at the beginning of the study. |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Both male and female Children diagnosed with spastic hemiplegic cerebral palsy (confirmed by a pediatric neurologist or rehabilitation specialist).
- Age range: 5 to 12 years (suitable for both bimanual and unilateral task-specific training).
- Gross Motor Function Classification System (GMFCS) levels I to III (ambulatory with or without limitations).
- Modified Ashworth Scale score between 1 and 3 in the upper limb muscles (indicating mild to moderate spasticity).
- Minimum cognitive ability to follow simple instructions, verified using screening tools (e.g., MMSE adapted for children).
Key exclusion criteria (5 listed)
- Children with mixed types of cerebral palsy (e.g., spastic quadriplegia, dyskinetic, or ataxic types).
- Recent orthopedic surgery or botulinum toxin injections in the affected upper limb within the past 6 months.
- Severe visual, auditory, or sensory deficits that could interfere with therapy participation or assessment accuracy.
- Uncontrolled epilepsy or other neurological conditions that could compromise safety during therapy.
- Fixed joint contractures or severe deformities in the upper limbs that limit passive range of motion Children with behavioral or psychological disorders (e.g., severe ADHD, autism spectrum disorder) that impair attention or participation
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 |
|---|---|---|
| Bimanual TrainingBimanual training is a structured, task-oriented upper limb rehabilitation program designed to promote coordinated use of both hands during functional, goal-directed activities. The intervention emphasizes active involvement of the affected upper limb within bilateral tasks rather than isolating it. Therapy will be delivered three sessions per week for 8 weeks, with each session lasting 60 minutes. Each session will consist of three 20-minute activity blocks with 5-minute rest intervals to reduce fatigue. Activities will include age-appropriate, real-life bilateral tasks such as buttoning shirts, folding clothes, opening containers, building with blocks, drawing with both hands, catching and throwing balls, and interactive bimanual play tasks. Task complexity will be progressively increased based on the child's tolerance and performance. Unlike unilateral training, this approach focuses on improving interlimb coordination, motor planning, and functional integration of both upper limb | Behavioural | group A Bimanual Training Group |
| Unilateral Task-Specific TrainingUnilateral Task-Specific Training | Behavioural | group B Unilateral Task-Specific Training Group |
Primary outcome
Change in Upper Limb Spasticity Measured by Modified Ashworth Scale (MAS)
Time frame: Baseline (Week 0) mid week(4), Post-intervention (Week 8)
Spasticity will be assessed using the Modified Ashworth Scale (MAS), a standardized clinical tool used to measure velocity-dependent resistance to passive muscle stretch. The MAS grades muscle tone on a scale from 0 to 4, with higher scores indicating greater spasticity. Upper limb muscle groups (including elbow flexors, wrist flexors, and finger flexors) will be evaluated by trained physiotherapists. The primary outcome will be the change in MAS score from baseline to post-intervention, comparing the effectiveness of bimanual training versus unilateral task-specific training in reducing spasticity.
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 6 Jul 2026.
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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.
Muhammad Hasnain Soomro, MSPTN principal investigator
The University of Lahore, Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bimanual Training and Unilateral Task-Specific Training in people with Spastic Cerebral Palsy (sCP), run by Montiha Azeem 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 6 inclusion and 5 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 6 Jul 2026. 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 Upper Limb Spasticity Measured by Modified Ashworth Scale (MAS) (time frame: Baseline (Week 0) mid week(4), Post-intervention (Week 8)). 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 6 Jul 2026.