Unilateral Spastic Cerebral PalsyNCT07482631
Robotic Glove Training on Hand Function in Unilateral Cerebral Palsy
A study testing Conventional Physical Therapy Program and Robotic Glove Training in people with Unilateral Spastic Cerebral Palsy, run by Beni-Suef University.
Trial summary
The purpose of the study is to investigate the effect of task-oriented robotic glove training on hand function in children with unilateral spastic cerebral palsy. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Unilateral Spastic Cerebral Palsy
- What is being tested?
- Conventional Physical Therapy Program and Robotic Glove Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 24 Mar 2026to 24 Jun 2026
- 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 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children ages will be ranged from 5 to 12 years.
- Children with mild to moderate spasticity of the wrist flexor muscles, graded 1,+1 and 2 according to the Modified Ashworth Scale.
- Ability to grasp and release objects with affected hand (Level I or II or III in accordance with the Manual Ability Classification System (MACS)).
- Sufficient cognition to follow simple verbal instructions.
Who cannot join
- Fractures, fixed deformities, or severe contractures in the upper limb.
- Visual or auditory defects.
- Previous surgical intervention or Botulinum toxin injection in the last 6 months.
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: Efficacy of Task-Oriented Robotic Glove Training on Hand Function in Children With Unilateral Spastic Cerebral Palsy. A Randomized Controlled Trial
The purpose of the study is to investigate the effect of task-oriented robotic glove training on hand function in children with unilateral spastic cerebral palsy.
Read the detailed description
Children with unilateral spastic cerebral palsy commonly experience impaired hand function, muscle weakness, and reduced fine motor control, which limit their ability to perform daily functional activities and decrease independence. Recent advances in rehabilitation technology, such as soft robotic gloves provide assisted and repetitive hand movements to facilitate motor learning that in turm improve hand function, and bimanual activities required for everyday life. Several studies support the benefit of soft robotic gloves on hand function among adults with neurological disorders while, there is limited evidence conducted its effect on children with unilateral cerebral palsy. Hence, there is need to study the the effect of task-oriented robotic glove training on hand function in children with unilateral spastic cerebral palsy.
Fourty children with unilateral spastic cerebral palsy (based on power analysis) from both sexes (5-12 years) will be recruited from outpatient clinics at faculty of physical theray, Deraya and Beni-Suef University, and different pediatric physical therapy rehabilitation clinics. They will be divided randomly into control group (20 children) and study group (20 children). Control group will be participated in conventional physical therapy program. Study group will be received task-oriented training with soft robotic glove in addition to the same conventional physical therapy in control group
- Conditions
- Unilateral Spastic Cerebral Palsy
- Being tested
- Conventional Physical Therapy Program, Robotic Glove Training
- Keywords
- Robotic Glove, Hand-Held Dynamometer, Pinch Gag, Finger Goniometer, Jebsen-Taylor Hand Function Test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Physical Therapy ProgramOther
The conventional physical therapy program include neurodevelopmental facilitation technique, proprioceptive training, facilitation of righting, equilibirum and protective reaction, passive stretching for tight muscles, active-assisted and active-free exercises for weak muscles, and hand skills training.
Robotic Glove TrainingOther
The conventional physical therapy program include neurodevelopmental facilitation technique, proprioceptive training, facilitation of righting, equilibirum and protective reaction, passive stretching for tight muscles, active-assisted and active-free exercises for weak muscles, and hand skills training. Also, task-oriented training in the form of grasping and releasing balls into a barrel, placing and removing pegs, and passing rings along rode with soft robotic glove.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Physical Therapy Program | Active comparator | Children with unilateral spastic cerebral palsy will receive conventional physical therapy program for 60 min./session Receives: Other: Conventional Physical Therapy Program |
| Robotic Glove Training | Experimental | Children with unilateral spastic cerebral palsy will receive conventional physical therapy program for 60 min./session in addition to robotic glove training for 30 min./session Receives: Other: Conventional Physical Therapy Program; Other: Robotic Glove Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grip Strength
Hand-held dynamometer will be used to measure hand grip strength. It is a valid and reliable device used to measure isometric grip strength.
Measured: Up to 12 weeks
Pinch Strength
Pinch gage will be used to measure lateral pinch, 2-point pinch, and 3-point pinch strength. It is a valid and reliable device used to measure pinch strength.
Measured: Up to 12 weeks
Finger Range of Motion
Hand-held steel finger goniometer will be used for measuring total active ROM of an individual digit (MP, PIP, DIP). It is a valid and reliable device used to measure finger ROM.
Measured: Up to 12 weeks
Secondary outcomes (1)
Fine and Gross Motor Hand Function
Jebsen-Taylor Hand Function Test (JTHFT) will be used for measuring fine and gross motor hand function. It has seven subsets which are writing, simulated page-turning, lifting small objects, simulated feeding, stacking, and lifting large, lightweight, and heavy objects. The subtests are scored by recording the number of seconds required to complete each test.
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start24 Mar 2026 (estimated)
- Primary completion24 Jun 2026 (estimated)
- Study completion24 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unilateral Spastic Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Beni-Suef 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
- Conventional Physical Therapy and Robotic Glove Training
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Wagdy, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07482631
- Sponsor's protocol ID
- FPTBSUREC/0311/15326
- Status last verified
- Mar 2026
- First submitted
- 15 Mar 2026
- Last updated
- 19 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Task-Oriented Robotic Glove Training on Hand Function in Children With Unilateral Spastic Cerebral Palsy. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07482631
- Acronym / sponsor ID
- FPTBSUREC/0311/15326
- Conditions
- Unilateral Spastic Cerebral Palsy
- Keywords
- Robotic Glove, Hand-Held Dynamometer, Pinch Gag, Finger Goniometer, Jebsen-Taylor Hand Function Test
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 24 Mar 2026 (estimated)
- Primary completion
- 24 Jun 2026 (estimated)
- Study completion
- 24 Jun 2026 (estimated)
- First posted
- 19 Mar 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.
The purpose of the study is to investigate the effect of task-oriented robotic glove training on hand function in children with unilateral spastic cerebral palsy.
Detailed description
Children with unilateral spastic cerebral palsy commonly experience impaired hand function, muscle weakness, and reduced fine motor control, which limit their ability to perform daily functional activities and decrease independence. Recent advances in rehabilitation technology, such as soft robotic gloves provide assisted and repetitive hand movements to facilitate motor learning that in turm improve hand function, and bimanual activities required for everyday life. Several studies support the benefit of soft robotic gloves on hand function among adults with neurological disorders while, there is limited evidence conducted its effect on children with unilateral cerebral palsy. Hence, there is need to study the the effect of task-oriented robotic glove training on hand function in children with unilateral spastic cerebral palsy.
Fourty children with unilateral spastic cerebral palsy (based on power analysis) from both sexes (5-12 years) will be recruited from outpatient clinics at faculty of physical theray, Deraya and Beni-Suef University, and different pediatric physical therapy rehabilitation clinics. They will be divided randomly into control group (20 children) and study group (20 children). Control group will be participated in conventional physical therapy program. Study group will be received task-oriented training with soft robotic glove in addition to the same conventional physical therapy in control group
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Conventional Physical Therapy and Robotic Glove Training
| Arm | Type | Receives |
|---|---|---|
| Conventional Physical Therapy Program | Active comparator | Other: Conventional Physical Therapy ProgramChildren with unilateral spastic cerebral palsy will receive conventional physical therapy program for 60 min./session |
| Robotic Glove Training | Experimental | Other: Conventional Physical Therapy Program, Other: Robotic Glove TrainingChildren with unilateral spastic cerebral palsy will receive conventional physical therapy program for 60 min./session in addition to robotic glove training for 30 min./session |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children ages will be ranged from 5 to 12 years.
- Children with mild to moderate spasticity of the wrist flexor muscles, graded 1,+1 and 2 according to the Modified Ashworth Scale.
- Ability to grasp and release objects with affected hand (Level I or II or III in accordance with the Manual Ability Classification System (MACS)).
- Sufficient cognition to follow simple verbal instructions.
Key exclusion criteria (3 listed)
- Fractures, fixed deformities, or severe contractures in the upper limb.
- Visual or auditory defects.
- Previous surgical intervention or Botulinum toxin injection in the last 6 months.
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 |
|---|---|---|
| Conventional Physical Therapy ProgramThe conventional physical therapy program include neurodevelopmental facilitation technique, proprioceptive training, facilitation of righting, equilibirum and protective reaction, passive stretching for tight muscles, active-assisted and active-free exercises for weak muscles, and hand skills training. | Other | Conventional Physical Therapy Program, Robotic Glove Training |
| Robotic Glove TrainingThe conventional physical therapy program include neurodevelopmental facilitation technique, proprioceptive training, facilitation of righting, equilibirum and protective reaction, passive stretching for tight muscles, active-assisted and active-free exercises for weak muscles, and hand skills training. Also, task-oriented training in the form of grasping and releasing balls into a barrel, placing and removing pegs, and passing rings along rode with soft robotic glove. | Other | Robotic Glove Training |
Primary outcome
Grip Strength
Time frame: Up to 12 weeks
Hand-held dynamometer will be used to measure hand grip strength. It is a valid and reliable device used to measure isometric grip strength.
Pinch Strength
Time frame: Up to 12 weeks
Pinch gage will be used to measure lateral pinch, 2-point pinch, and 3-point pinch strength. It is a valid and reliable device used to measure pinch strength.
Finger Range of Motion
Time frame: Up to 12 weeks
Hand-held steel finger goniometer will be used for measuring total active ROM of an individual digit (MP, PIP, DIP). It is a valid and reliable device used to measure finger ROM.
1 secondary outcome
Fine and Gross Motor Hand Function
Time frame: Up to 12 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 19 Mar 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.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Physical Therapy Program and Robotic Glove Training in people with Unilateral Spastic Cerebral Palsy, run by Beni-Suef 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 4 inclusion and 3 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 19 Mar 2026. 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 Eman Wagdy, PH.D (01008079576, Eman.wagdy@pt.bsu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grip Strength (time frame: Up to 12 weeks). The study lists 3 primary outcomes in all. 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 19 Mar 2026.