Hemiplegic Cerebral PalsyUL/SMC/ADL/CPNCT07907497
EFFECT OF ROBOTIC GLOVES TRAINING ON UPPER LIMB COORDINATION, SELECTIVE MOTOR CONTROL AND ACTIVITIES OF DAILY LIVING IN CHILDREN WITH HEMIPARETIC CEREBRAL PALSY.
A study testing Robotic Glove Therapy and Occupational Therapy Group in people with Hemiplegic Cerebral Palsy, run by Cairo University at 1 site in Egypt.
Trial summary
The purposes of the current study will be to assess the effect of robotic gloves training on upper limb coordination, selective motor control (Wrist Extension/Flexion, Finger Flexion/Extension, Thumb Opposition (tip to tip pincer), Thumb extension (key grip) and activities of daily living in children with hemiparetic… Read more about this study
- Who is it for?
- Ages 6 to 8 years
- Conditions the study is for
- Hemiplegic Cerebral Palsy
- What is being tested?
- Robotic Glove Therapy and Occupational Therapy Group
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2026to 1 Apr 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 6 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- • Their age will be ranged from 6 to 8years.
- They will have a degree of spasticity ranged from 1to 1+ according to the Modified Ashworth scale (MAS) (Bohannon and Smith, 1987) (Appendix II).
- The children will be at level I and II on Gross Motor Function Classification System (GMFCS) (Palisano et al., 1997) (Appendix III).
- The children will be at level II and III on Manual Ability Classification System (MACS) (Eliasson et al., 2006) (Appendix IV).
- They will be able to follow the instructions.
Who cannot join
- • Visual or hearing defects.
- Surgical intervention of upper limb.
- Botulinum toxin injection into upper limb in the last 6 months prior to study.
- Fractures of upper limb.
- Convulsions.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Outpatient Clinic of Faculty of Physical Therapy, Cairo University
Cairo
About this study
The purposes of the current study will be to assess the effect of robotic gloves training on upper limb coordination, selective motor control (Wrist Extension/Flexion, Finger Flexion/Extension, Thumb Opposition (tip to tip pincer), Thumb extension (key grip) and activities of daily living in children with hemiparetic cerebral palsy.
Read the detailed description
Cerebral palsy (CP) is a group of conditions that affect movement and posture. It's caused by damage that occurs to the developing brain, most often before birth (Paul et al., 2022).
Etiological aspects of CP can be defined as prenatal etiology in 22% of the cases, probable perinatal etiology in 40% and undefined etiology in 38% of the cases (Hagberg et al., 1996).
Children with CP commonly have impairment of upper limb function, with various studies reporting a prevalence ranging from 57 to 83% (Makki et al., 2014).
Cerebral palsy (CP) also limits the International Classification of Functioning, Disability and Health (ICF) domain of activities, which refers to the ability to execute an essential task or action of daily living (e.g., eating, drinking, grooming, or dressing) (Penta et al., 2001).
Hemiparetic CP is a form of CP in which one arm and leg on either the right or left side of the body is affected. Hemiparetic CP is the most common CP syndrome in children born at term (Miller et al., 2000).
Children with hemiparetic CP have unilateral prehensile dysfunction as a consequence of lesions in the sensorimotor cortex and corticospinal tract. Children whose hemiparesis involves the upper limb to a greater extent than the lower (arm-dominant hemiparesis) are much more likely to experience learning difficulties than those whose clinical pattern is leg-dominant (Wojciech et al.,2003).
Upper limb coordination is crucial for hand functional manual abilities and plays a vital role in functional independence and overall quality of life (Camila et al., 2016). Therefore, targeting upper limb coordination approaches with older children with CP is essential for maintaining or improving their performance (Faccioli et al., 2023).
Selective motor control is defined as isolated muscle activation during a voluntary posture or movement in a selected motion pattern. Therefore, SMC should be considered during evaluation and rehabilitation of affected UEF in children with spastic CP. However, there are not enough studies in the literature (Kilcioglu et al., 2019).
Children with unilateral spastic CP seldom use their paretic hand spontaneously in daily activities (Fedrizzi et al., 2003).
Children with hemiplegia often display difficulties in mobility and sensory functioning. These difficulties affect their activities in daily living and thus have a negative impact on the quality of their life (Sharma et al., 2021).
Robotic gloves are more compact forms than exoskeleton devices. The structure of robotic devices is similar to a glove and envelops the paretic hand. The glove-like nature of these devices gives them intuitive functionality and can reduce stresses on the hand joints (Delph et al., 2013).
A direct benefit of assistive robotic gloves has been demonstrated over recent years on strength and functional ability in multiple studies with spinal cord injury (SCI) patients, stroke patients, and children with neurological hand limitations and elderly with age-related hand limitations (Zhou et al., 2019).
- Conditions
- Hemiplegic Cerebral Palsy
- Being tested
- Robotic Glove Therapy, Occupational Therapy Group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic Glove TherapyDevice
"A rehabilitation program using a high-tech robotic glove that features individual finger control to allow independent finger movement. Participants will use the device to perform repetitive task-specific training, upper limb coordination drills, and activities of daily living (ADL) exercises designed to improve hemiparetic hand functionality and selective motor control."
Occupational Therapy GroupBehavioural
"A traditional rehabilitation program focused on upper limb mobilization, functional manual dexterity training, and activities of daily living (ADL) tasks. Exercises are performed using standard clinical therapeutic equipment and manual therapist facilitation without any robotic device assistance."
| Study group | Role | What they receive |
|---|---|---|
| Robotic Glove Therapy | Experimental | "Children with hemiplegic cerebral palsy in this group will perform structured upper limb coordination, selective motor control, and activities of daily living (ADL) training while wearing a robotic glove. The intervention utilizes the device's individual finger control capabilities to facilitate independent finger movement and targeted manual dexterity exercises." Receives: Device: Robotic Glove Therapy |
| Conventional Occupational Therapy | Active comparator | "Children with hemiplegic cerebral palsy in this group will receive standard, conventional occupational therapy sessions. The intervention focuses on identical upper limb coordination exercises, selective motor control training, and functional activities of daily living (ADL) training using traditional manual techniques without the assistance of a robotic device." Receives: Behavioral: Occupational Therapy Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2) - Upper Limb Coordination Subtest
The BOT-2 upper limb coordination subtest evaluates fine motor control, catching, and throwing skills involving the hemiplegic arm. It provides a point score that converts to standard scores (ranging from 1 to 35) or scale scores. Higher scores indicate superior upper limb coordination, motor proficiency, and manual control.
Measured: Baseline (Week 0) and post-intervention (Week 12)
Secondary outcomes (2)
Test of Selective Control (TASC) Score
The Test of Selective Control (TASC) scale evaluates upper limb selective motor control (SMC) in children with hemiplegic cerebral palsy. It measures the child's ability to perform isolated joint movements outside of an obligate synergy pattern across specific upper extremity joints (including the shoulder, elbow, forearm, wrist, and fingers). Higher scores indicate superior selective motor control and a greater capacity to move individual upper limb segments independently.
Measured: Baseline (Week 0) and post-intervention (Week 12)
Functional Independence Measure for Children (WeeFIM) - Self-Care Domain
The WeeFIM scale tracks functional independence and the level of assistance required by the child to complete daily tasks. The evaluation will focus on the Self-Care domain (eating, grooming, bathing, dressing, toileting) which heavily relies on upper limb function. Scores range from 8 to 56 for this domain, with higher scores reflecting greater functional independence in activities of daily living (ADLs).
Measured: Baseline (Week 0) and post-intervention (Week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemiplegic Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Cairo 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
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rabab Ragab Ahmed Barkat, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07907497
- Sponsor's protocol ID
- Robotic glove train on hemi CP
- Acronym
- UL/SMC/ADL/CP
- Status last verified
- Oct 2026
- First submitted
- 25 Oct 2026
- Last updated
- 30 Oct 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 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECT OF ROBOTIC GLOVES TRAINING ON UPPER LIMB COORDINATION, SELECTIVE MOTOR CONTROL AND ACTIVITIES OF DAILY LIVING IN CHILDREN WITH HEMIPARETIC CEREBRAL PALSY.
- ClinicalTrials.gov ID
- NCT07907497
- Acronym / sponsor ID
- UL/SMC/ADL/CP / Robotic glove train on hemi CP
- Conditions
- Hemiplegic Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 30 Oct 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 purposes of the current study will be to assess the effect of robotic gloves training on upper limb coordination, selective motor control (Wrist Extension/Flexion, Finger Flexion/Extension, Thumb Opposition (tip to tip pincer), Thumb extension (key grip) and activities of daily living in children with hemiparetic cerebral palsy.
Detailed description
Cerebral palsy (CP) is a group of conditions that affect movement and posture. It's caused by damage that occurs to the developing brain, most often before birth (Paul et al., 2022).
Etiological aspects of CP can be defined as prenatal etiology in 22% of the cases, probable perinatal etiology in 40% and undefined etiology in 38% of the cases (Hagberg et al., 1996).
Children with CP commonly have impairment of upper limb function, with various studies reporting a prevalence ranging from 57 to 83% (Makki et al., 2014).
Cerebral palsy (CP) also limits the International Classification of Functioning, Disability and Health (ICF) domain of activities, which refers to the ability to execute an essential task or action of daily living (e.g., eating, drinking, grooming, or dressing) (Penta et al., 2001).
Hemiparetic CP is a form of CP in which one arm and leg on either the right or left side of the body is affected. Hemiparetic CP is the most common CP syndrome in children born at term (Miller et al., 2000).
Children with hemiparetic CP have unilateral prehensile dysfunction as a consequence of lesions in the sensorimotor cortex and corticospinal tract. Children whose hemiparesis involves the upper limb to a greater extent than the lower (arm-dominant hemiparesis) are much more likely to experience learning difficulties than those whose clinical pattern is leg-dominant (Wojciech et al.,2003).
Upper limb coordination is crucial for hand functional manual abilities and plays a vital role in functional independence and overall quality of life (Camila et al., 2016). Therefore, targeting upper limb coordination approaches with older children with CP is essential for maintaining or improving their performance (Faccioli et al., 2023).
Selective motor control is defined as isolated muscle activation during a voluntary posture or movement in a selected motion pattern. Therefore, SMC should be considered during evaluation and rehabilitation of affected UEF in children with spastic CP. However, there are not enough studies in the literature (Kilcioglu et al., 2019).
Children with unilateral spastic CP seldom use their paretic hand spontaneously in daily activities (Fedrizzi et al., 2003).
Children with hemiplegia often display difficulties in mobility and sensory functioning. These difficulties affect their activities in daily living and thus have a negative impact on the quality of their life (Sharma et al., 2021).
Robotic gloves are more compact forms than exoskeleton devices. The structure of robotic devices is similar to a glove and envelops the paretic hand. The glove-like nature of these devices gives them intuitive functionality and can reduce stresses on the hand joints (Delph et al., 2013).
A direct benefit of assistive robotic gloves has been demonstrated over recent years on strength and functional ability in multiple studies with spinal cord injury (SCI) patients, stroke patients, and children with neurological hand limitations and elderly with age-related hand limitations (Zhou et al., 2019).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotic Glove Therapy | Experimental | Device: Robotic Glove Therapy"Children with hemiplegic cerebral palsy in this group will perform structured upper limb coordination, selective motor control, and activities of daily living (ADL) training while wearing a robotic glove. The intervention utilizes the device's individual finger control capabilities to facilitate independent finger movement and targeted manual dexterity exercises." |
| Conventional Occupational Therapy | Active comparator | Behavioral: Occupational Therapy Group"Children with hemiplegic cerebral palsy in this group will receive standard, conventional occupational therapy sessions. The intervention focuses on identical upper limb coordination exercises, selective motor control training, and functional activities of daily living (ADL) training using traditional manual techniques without the assistance of a robotic device." |
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- • Their age will be ranged from 6 to 8years.
Key exclusion criteria (5 listed)
- • Visual or hearing defects.
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 Glove Therapy"A rehabilitation program using a high-tech robotic glove that features individual finger control to allow independent finger movement. Participants will use the device to perform repetitive task-specific training, upper limb coordination drills, and activities of daily living (ADL) exercises designed to improve hemiparetic hand functionality and selective motor control." | Device | Robotic Glove Therapy |
| Occupational Therapy Group"A traditional rehabilitation program focused on upper limb mobilization, functional manual dexterity training, and activities of daily living (ADL) tasks. Exercises are performed using standard clinical therapeutic equipment and manual therapist facilitation without any robotic device assistance." | Behavioural | Conventional Occupational Therapy |
Primary outcome
Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2) - Upper Limb Coordination Subtest
Time frame: Baseline (Week 0) and post-intervention (Week 12)
The BOT-2 upper limb coordination subtest evaluates fine motor control, catching, and throwing skills involving the hemiplegic arm. It provides a point score that converts to standard scores (ranging from 1 to 35) or scale scores. Higher scores indicate superior upper limb coordination, motor proficiency, and manual control.
2 secondary outcomes
Test of Selective Control (TASC) Score
Time frame: Baseline (Week 0) and post-intervention (Week 12)
Functional Independence Measure for Children (WeeFIM) - Self-Care Domain
Time frame: Baseline (Week 0) and post-intervention (Week 12)
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 30 Oct 2026.
- Related InfoLink provided by the sponsor.
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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.
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 Glove Therapy and Occupational Therapy Group in people with Hemiplegic Cerebral Palsy, run by Cairo University at 1 site in Egypt.
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 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 30 Oct 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 Egypt. 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 Rabab Ragab, phd (02 01227110268, drrababragab14@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2) - Upper Limb Coordination Subtest (time frame: Baseline (Week 0) and post-intervention (Week 12)). 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 30 Oct 2026.