Cerebral Palsy, HemiplegicNCT07571668
Effects of Robotic Hand Therapy on Hand Function and Dexterity in Cerebral Palsy
A study testing Robotic Hand Therapy and Conventional physical Therapy in people with Cerebral Palsy, Hemiplegic, run by Riphah International University at 1 site in Pakistan.
Trial summary
This randomized controlled trial aims to evaluate the effects of robotic hand therapy using the Syrebo E12 soft-robotic glove compared with conventional physiotherapy on hand function and manual dexterity in children with hemiplegic cerebral palsy. Read more about this study
- Who is it for?
- Ages 7 to 15 years
- Conditions the study is for
- Cerebral Palsy, Hemiplegic
- What is being tested?
- Robotic Hand Therapy and Conventional physical Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 sitePakistan
- Study dates
- May 2026to 31 Dec 2027
- 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 7 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients diagnosed with Hemiplegic type of Cerebral palsy
- Age 7 to 15 years
- Ability to understand and follow simple instructions
- Gross Motor Function Classification System (GMFCS) levels I-III (ambulatory)
- Manual Ability Classification system (MACS) I to III
- Stable medical condition (no major changes in medication or therapy in the past 3 months).
Who cannot join
- Patients with severe cognitive dysfunction.
- Fixed contractures or deformities of the upper limb that would prevent safe use of the robotic device.
- Recent upper limb surgery, botulinum toxin injection, or casting within the past 6 months.
- Uncontrolled epilepsy or other unstable medical conditions.
- Visual or auditory impairments that would interfere with assessment or therapy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Riphah International University
Islamabad
Mudassar Ali, Ph.D*, +923015255090, mudassarpt@gmail.com
About this study
Official title: Effects of Robotic Hand Therapy in Comparison to Conventional Therapy on Hand Function and Dexterity in Children With Hemiplegic Cerebral Palsy; a Randomized Controlled Trial
This randomized controlled trial aims to evaluate the effects of robotic hand therapy using the Syrebo E12 soft-robotic glove compared with conventional physiotherapy on hand function and manual dexterity in children with hemiplegic cerebral palsy. Children aged 7-15 years, classified as GMFCS I-III and MACS I-III, will be recruited from multiple rehabilitation centers in Pakistan. Participants will be randomly allocated (1:1) to either robotic therapy or standard physiotherapy, receiving 45-minute sessions, three times per week for 8 weeks.
The primary outcome is functional hand performance measured by the Jebsen-Taylor Hand Function Test (JTHFT). Secondary outcomes include ABILHAND-Kids, Box and Block Test, Nine-Hole Peg Test, grip strength, and qualitative feedback. Assessments will occur at baseline, week 4, week 8, and at a 6-month follow-up. A mixed-effects repeated-measures ANCOVA will be used for analysis following the intention-to-treat principle.
- Conditions
- Cerebral Palsy, Hemiplegic
- Being tested
- Robotic Hand Therapy, Conventional physical Therapy
- Keywords
- cerebral palsy, hemiplegia, hand function, Robotic hand, Robotic Glove
- Medical subject headings
- Cerebral Palsy, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic Hand TherapyDevice
Participants in this group will receive robotic hand therapy using a glove-based robotic rehabilitation device that provides passive, active-assisted, and resistive training to facilitate repetitive, task-specific hand movements. Each 45-minute session will be delivered three times per week for six weeks under therapist supervision, focusing on improving grasp-release patterns, finger mobility, and functional hand use. Therapy intensity will be progressively adjusted based on performance and tolerance, and all sessions will be monitored for safety and adverse events.
Conventional physical TherapyOther
Participants in this group will receive conventional physical therapy based on neurodevelopmental and task-oriented principles, including stretching, strengthening, sensory re-education, and functional hand-use training. Sessions will last 45 minutes, three times per week for six weeks, delivered by a licensed physical therapist following a standardized treatment checklist. The program targets improvements in hand strength, dexterity, range of motion, and fine motor skills, with safety and treatment fidelity monitored throughout.
| Study group | Role | What they receive |
|---|---|---|
| Robotic Hand Therapy | Experimental | Not described Receives: Device: Robotic Hand Therapy |
| Conventional Physical Therapy | Active comparator | Not described Receives: Other: Conventional physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Jebsen-Taylor Hand Function Test
Jebsen-Taylor Hand Function Test (JTHFT) will objectively quantify functional capacity of hand.
Measured: 8 Weeks
Secondary outcomes (4)
ABILHAND-Kids
ABILHAND-Kids for perceived manual ability in daily activities (Subjective assessment).
Measured: 8 Weeks
Box and Block Test
Box and Block Test [BBT] for unilateral gross manual dexterity
Measured: 8 Weeks
Nine-Hole Peg Test (NHPT)
Nine-Hole Peg Test (NHPT) fine finger dexterity (time to place and remove pegs)
Measured: 8 weeks
o'connor test
The O'Connor Finger Dexterity Test is a, standardized, timed, aptitude assessment designed to measure fine motor skills and rapid, precise manipulation of small objects. It is widely used in vocational testing, industrial hiring (assembly line work), and clinical rehab to evaluate finger dexterity by placing three pins into 100 holes.
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 posted6 May 2026
- Study startMay 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy, HemiplegicStudies 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
- Model description
- Randomized Controlled Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qamar Mehmood, Ph.D., Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07571668
- Sponsor's protocol ID
- RCRAHS-ISB/REC/PhD/011110
- Status last verified
- Apr 2026
- First submitted
- 30 Apr 2026
- Last updated
- 6 May 2026
- 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 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Robotic Hand Therapy in Comparison to Conventional Therapy on Hand Function and Dexterity in Children With Hemiplegic Cerebral Palsy; a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07571668
- Acronym / sponsor ID
- RCRAHS-ISB/REC/PhD/011110
- Conditions
- Cerebral Palsy, Hemiplegic
- Keywords
- cerebral palsy, hemiplegia, hand function, Robotic hand, Robotic Glove
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 6 May 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.
This randomized controlled trial aims to evaluate the effects of robotic hand therapy using the Syrebo E12 soft-robotic glove compared with conventional physiotherapy on hand function and manual dexterity in children with hemiplegic cerebral palsy. Children aged 7-15 years, classified as GMFCS I-III and MACS I-III, will be recruited from multiple rehabilitation centers in Pakistan. Participants will be randomly allocated (1:1) to either robotic therapy or standard physiotherapy, receiving 45-minute sessions, three times per week for 8 weeks.
The primary outcome is functional hand performance measured by the Jebsen-Taylor Hand Function Test (JTHFT). Secondary outcomes include ABILHAND-Kids, Box and Block Test, Nine-Hole Peg Test, grip strength, and qualitative feedback. Assessments will occur at baseline, week 4, week 8, and at a 6-month follow-up. A mixed-effects repeated-measures ANCOVA will be used for analysis following the intention-to-treat principle.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Robotic Hand Therapy | Experimental | Device: Robotic Hand Therapy |
| Conventional Physical Therapy | Active comparator | Other: Conventional physical Therapy |
Who may qualify
- Ages
- 7 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Patients diagnosed with Hemiplegic type of Cerebral palsy
- Age 7 to 15 years
- Ability to understand and follow simple instructions
- Gross Motor Function Classification System (GMFCS) levels I-III (ambulatory)
- Manual Ability Classification system (MACS) I to III
Key exclusion criteria (5 listed)
- Patients with severe cognitive dysfunction.
- Fixed contractures or deformities of the upper limb that would prevent safe use of the robotic device.
- Recent upper limb surgery, botulinum toxin injection, or casting within the past 6 months.
- Uncontrolled epilepsy or other unstable medical conditions.
- Visual or auditory impairments that would interfere with assessment or 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 |
|---|---|---|
| Robotic Hand TherapyParticipants in this group will receive robotic hand therapy using a glove-based robotic rehabilitation device that provides passive, active-assisted, and resistive training to facilitate repetitive, task-specific hand movements. Each 45-minute session will be delivered three times per week for six weeks under therapist supervision, focusing on improving grasp-release patterns, finger mobility, and functional hand use. Therapy intensity will be progressively adjusted based on performance and tolerance, and all sessions will be monitored for safety and adverse events. | Device | Robotic Hand Therapy |
| Conventional physical TherapyParticipants in this group will receive conventional physical therapy based on neurodevelopmental and task-oriented principles, including stretching, strengthening, sensory re-education, and functional hand-use training. Sessions will last 45 minutes, three times per week for six weeks, delivered by a licensed physical therapist following a standardized treatment checklist. The program targets improvements in hand strength, dexterity, range of motion, and fine motor skills, with safety and treatment fidelity monitored throughout. | Other | Conventional Physical Therapy |
Primary outcome
Jebsen-Taylor Hand Function Test
Time frame: 8 Weeks
Jebsen-Taylor Hand Function Test (JTHFT) will objectively quantify functional capacity of hand.
4 secondary outcomes
ABILHAND-Kids
Time frame: 8 Weeks
Box and Block Test
Time frame: 8 Weeks
Nine-Hole Peg Test (NHPT)
Time frame: 8 weeks
o'connor test
Time frame: 8 Weeks
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 6 May 2026.
- Individual participant dataSharing planned: No
Related trials for Cerebral Palsy, Hemiplegic
Not yet recruiting
Effect of Robotic Gloves Training on Upper Limb Coordination, Selective Motor Control and Activities of Daily Living in Children With Hemiparetic Cerebral Palsy
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Not yet recruiting
Effects of Upper Extremity Physiotherapy and Home Exercises on Functional Outcomes in Individuals With Stroke
Stroke
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Short-Term Effects of Manual Therapy Prior to Neuromotor Therapy in Children With Cerebral Palsy
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Active, not recruiting
Virtual Reality Vs Postural Control Training in Children With Cerebral Palsy
Children With Hemiplegic cp
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Neuro-MoD: Neuroplasticity With Motor Development
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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.
Qamar Mehmood, Ph.D. principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic Hand Therapy and Conventional physical Therapy in people with Cerebral Palsy, Hemiplegic, run by Riphah International University 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: opening soon, as of the sponsor's last update on 6 May 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?
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 Qamar Mehmood, Ph.D. (+923335151063, qamar.mehmood@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Jebsen-Taylor Hand Function Test (time frame: 8 Weeks). 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 May 2026.