Robotic Glove Training on Hand Function in Unilateral Cerebral Palsy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Conventional Physical Therapy Program, Robotic Glove Training.
- Who it may be relevant to
- Registry conditions: Unilateral Spastic Cerebral Palsy. Basic parameters: 5 years — 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy of Task-Oriented Robotic Glove Training on Hand Function in Children With Unilateral Spastic Cerebral Palsy. A Randomized Controlled Trial
Overview
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
- 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.
Primary outcome measures
- Grip Strength [Time frame: Up to 12 weeks]
- Pinch Strength [Time frame: Up to 12 weeks]
- Finger Range of Motion [Time frame: Up to 12 weeks]
Secondary outcome measures (1)
- Fine and Gross Motor Hand Function [Time frame: Up to 12 weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07482631 · FPTBSUREC/0311/15326