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Robotic Glove Training on Hand Function in Unilateral Cerebral Palsy

Efficacy of Task-Oriented Robotic Glove Training on Hand Function in Children With Unilateral Spastic Cerebral Palsy. A Randomized Controlled Trial

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07482631
Enrollment
40
Registered
2026-03-19
Start date
2026-03-24
Completion date
2026-06-24
Last updated
2026-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unilateral Spastic Cerebral Palsy

Keywords

Robotic Glove, Hand-Held Dynamometer, Pinch Gag, Finger Goniometer, Jebsen-Taylor Hand Function Test

Brief 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.

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

Interventions

OTHERConventional Physical Therapy Program

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.

OTHERRobotic Glove Training

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.

Sponsors

Beni-Suef University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Intervention model description

Conventional Physical Therapy and Robotic Glove Training

Eligibility

Sex/Gender
ALL
Age
5 Years to 12 Years
Healthy volunteers
No

Inclusion criteria

1. Children ages will be ranged from 5 to 12 years. 2. Children with mild to moderate spasticity of the wrist flexor muscles, graded 1,+1 and 2 according to the Modified Ashworth Scale. 3. Ability to grasp and release objects with affected hand (Level I or II or III in accordance with the Manual Ability Classification System (MACS)). 4. Sufficient cognition to follow simple verbal instructions.

Exclusion criteria

1. Fractures, fixed deformities, or severe contractures in the upper limb. 2. Visual or auditory defects. 3. Previous surgical intervention or Botulinum toxin injection in the last 6 months.

Design outcomes

Primary

MeasureTime frameDescription
Grip StrengthUp to 12 weeksHand-held dynamometer will be used to measure hand grip strength. It is a valid and reliable device used to measure isometric grip strength.
Pinch StrengthUp to 12 weeksPinch 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 MotionUp to 12 weeksHand-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.

Secondary

MeasureTime frameDescription
Fine and Gross Motor Hand FunctionUp to 12 weeksJebsen-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.

Contacts

CONTACTEman Wagdy, PH.D
Eman.wagdy@pt.bsu.edu.eg01008079576
CONTACTAbd Elrahman Refaat, M.Sc
Abdorefaat337@gmail.com01069278792

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026