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AzTrials

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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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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
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

Other trials in Egypt

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).

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 groups in NCT07907497
Study groupRoleWhat they receive
Robotic Glove TherapyExperimental"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 TherapyActive 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.

  1. 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)
  1. 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)

  2. 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.

  1. First posted30 Oct 2026
  2. Study start1 Nov 2026 (estimated)
  3. Primary completion1 Mar 2027 (estimated)
  4. Study completion1 Apr 2027 (estimated)

Resources

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)
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

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.

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