Status:
COMPLETED
The Effect of Functional Electrical Stimulation on Gait and Balance in Children With Hemiplegic Cerebral Palsy
Lead Sponsor:
Umm Al-Qura University
Conditions:
Cerebral Palsy
Eligibility:
All Genders
8-10 years
Phase:
NA
Brief Summary
The aim of this study will be to evaluate the effect of FES on stimulation of the anterior tibial group by using the WalkAide foot drop stimulator on improving walking and balance abilities in childre...
Detailed Description
The aim of this study will be to evaluate the effect of FES on improving walking and balance abilities in children with hemiplegic CP. Forty children with hemiplegic CP will be assigned randomly into ...
Eligibility Criteria
Inclusion
- Their weight should be less than 40 kg.
- The spasticity degrees of the affected lower limb will range between grades (1, 1+ \& 2) according to Modified Ashworth Scale (MAS).
- Those children functioning scores at Gross Motor Function Classification System (GMFCS) Levels I and II.
- They can walk 10 min conditionally without an orthosis.
- Ought to be intellectually skilled and ready to comprehend and take after directions.
- They will have neither serious nor recurring medical complications.
- Children's height will be more than 100 cm to fit with the Biodex balance equipment that will be used in this study to evaluate balance performance.
- No serious hip \& knee flexion tightness will be present. Knee flexion at starting contact should be between 20-40º .
- Peroneal nerve and the proximal leg muscles ought to be in place.
- They ought to have no significant issues influencing balance other than spasticity.
Exclusion
- Children who demonstrate skin diseases or allergic reactions to adhesive tape or any other materials used in this study.
- Children with visual, auditory or perceptual deficits.
- Children with surgical interference for the lower limb.
- Children with seizures or epilepsy.
- Children who received botulinum toxin in the lower extremity musculature during the past 6 months or who wish to receive it within the period of study, other spasticity medication within 3 months of pre-treatment testing .
- Children with pacemakers or other diseases that are contraindicated by electrical stimulation.
Key Trial Info
Start Date :
February 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 15 2021
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04269798
Start Date
February 11 2020
End Date
April 15 2021
Last Update
April 28 2021
Active Locations (1)
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1
Maternity and Children Hospital
Mecca, Saudi Arabia, 149239