The Effect of Functional Electrical Stimulation on Gait and Balance in Children With Hemiplegic Cerebral Palsy
NCT ID: NCT04269798
Last Updated: 2021-04-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2020-02-11
2021-04-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
DOUBLE
Study Groups
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Traditional Treatment Arm
Will receive conventional rehabilitation program for the lower limbs, balance and gait training. Two hours of conventional physical therapy program /session - 3 sessions/week/ three successive months.
Traditional Treatment
conventional rehabilitation program for lower limb, balance and gait training
Functional Electrical Stimulation Group
Will receive 1.5 hours of conventional physical therapy program /session - 3 sessions weekly - three successive months + 1/2 hour of the gait training program with functional electrical stimulation /session - 3 sessions weekly - three successive months.
Traditional Treatment
conventional rehabilitation program for lower limb, balance and gait training
Interventions
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Traditional Treatment
conventional rehabilitation program for lower limb, balance and gait training
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
8 Years
10 Years
ALL
Yes
Sponsors
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Umm Al-Qura University
OTHER
Responsible Party
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Shamekh Mohamed El-Shamy
Professor
Principal Investigators
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Shamekh M El-Shamy, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Professor
Locations
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Maternity and Children Hospital
Mecca, , Saudi Arabia
Countries
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Other Identifiers
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Umm AlQura University
Identifier Type: -
Identifier Source: org_study_id
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