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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Unilateral Spastic Cerebral Palsy
• Intervention / Treatment: Other: Conventional Physical Therapy Program; Other: Robotic Glove Training

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eman Wagdy, PH.D; Phone Number: 01008079576; Email: Eman.wagdy@pt.bsu.edu.eg
• Study Contact Backup: Name: Abd Elrahman Refaat, M.Sc; Phone Number: 01069278792; Email: Abdorefaat337@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional Physical Therapy Program; Children with unilateral spastic cerebral palsy will receive conventional physical therapy program for 60 min./session	Other: Conventional 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.
Experimental: Robotic Glove Training; 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	Other: Conventional 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.; Other: Robotic 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Up to 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 12 weeks

Collaborators and Investigators

• Sponsor: Beni-Suef University

Study record dates

Study Major Dates

• Study Start (Estimated): March 24, 2026
• Primary Completion (Estimated): June 24, 2026
• Study Completion (Estimated): June 24, 2026

Study Registration Dates

• First Submitted: March 15, 2026
• First Submitted That Met QC Criteria: March 15, 2026
• First Posted (Actual): March 19, 2026

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 15, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Jebsen-Taylor Hand Function Test; Robotic Glove; Hand-Held Dynamometer; Pinch Gag; Finger Goniometer
• Other Study ID Numbers: FPTBSUREC/0311/15326

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No