Health TrialsbyHealthPanel

Robotic Glove Training on Hand Function in Unilateral Cerebral Palsy

ConditionUnilateral Spastic Cerebral Palsy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-12
SponsorBeni-Suef University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Conventional Physical Therapy Program

    Other intervention

    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 intervention

    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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Conventional Physical Therapy ProgramActive comparator 1 intervention
Group B: Robotic Glove TrainingExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Up to 12 weeks
2

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.

Time frame
Up to 12 weeks
3

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.

Time frame
Up to 12 weeks

Secondary outcomes

1

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.

Time frame
Up to 12 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beni-Suef University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: