Robotic Glove Training on Hand Function in Unilateral Cerebral Palsy

NCT07482631 | Not Yet Recruiting

• 1 other identifier: FPTBSUREC/0311/15326
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Unilateral Spastic Cerebral Palsy

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Fine and Gross Motor Hand Function

  Up to 12 weeks

Study Arms (2)

Conventional Physical Therapy Program

ACTIVE COMPARATOR

Children with unilateral spastic cerebral palsy will receive conventional physical therapy program for 60 min./session

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

Other: Conventional Physical Therapy Program; Other: Robotic Glove Training

Interventions

Conventional Physical Therapy Program OTHER

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.

Conventional Physical Therapy Program; Robotic Glove Training

Robotic Glove Training OTHER

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.

Robotic Glove Training

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beni-Suef University: lead

Central Study Contacts

Eman Wagdy, PH.D

CONTACT

01008079576; Eman.wagdy@pt.bsu.edu.eg

Abd Elrahman Refaat, M.Sc

CONTACT

01069278792; Abdorefaat337@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Conventional Physical Therapy and Robotic Glove Training

Study Record Dates

• First Submitted: March 15, 2026
• First Posted: March 19, 2026
• Study Start: March 24, 2026
• Primary Completion: June 24, 2026
• Study Completion: June 24, 2026
• Last Updated: March 19, 2026

Record last verified: 2026-03