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NCT Number: NCT07482631

Robotic Glove Training on Hand Function in Unilateral Cerebral Palsy

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.

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Key information

Conditions

Unilateral Spastic Cerebral Palsy

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Grip Strength

    Time frame: Up to 12 weeks

    Hand-held dynamometer will be used to measure hand grip strength. It is a valid and reliable device used to measure isometric grip strength.

  2. Pinch Strength

    Time frame: Up to 12 weeks

    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.

  3. Finger Range of Motion

    Time frame: Up to 12 weeks

    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.

Secondary outcomes

  1. Fine and Gross Motor Hand Function

    Time frame: Up to 12 weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Abd Elrahman Refaat, M.Sc

CONTACT

[email protected]

01069278792

Eman Wagdy, PH.D

CONTACT

[email protected]

01008079576

Sponsors and collaborators

Lead sponsor

Beni-Suef University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 19, 2026
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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