- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07599267
Effect of Reciprocal Electrical Stimulation on Balance and Quality of Life in Hemiparetic CP
Effect of Reciprocal Neuromuscular Electrical Stimulation on Balance and Quality of Life in Children With Hemiparesis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Neuromuscular Electrical Stimulation is widely used to reduce spasticity and strengthen weak muscles.
Reciprocal electrical stimulation ( RES),which mimic natural agonist-antagonist muscle activation , is a promising too for neuromuscular re-education.
RES has been studied for knee stability in diplegic CP and ankle control in adults but its effect on static and dynamic balance in hemiparetic CP remain unexplored . so this study may be a guide in management of balance problems in children with hemiparesis
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- age range from 6 to10 years .
- spasticity level 1 , 1+ in lower limb muscles according to Modified Ashworth Scale.
- Gross Motor Function Classification System (GMFCS) level 1.
- Able to follow instructions.
Exclusion Criteria:
- Affections of musculoskeletal system including fixed contractures.
- Visual , auditory , vestibular ,sensory disorders or cerebellar disease .
- Botox injection in the last 6 months in gastrocnemius
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: a group of hemiparetic children their balance is disturbed
children diagnosed with hemiparetic CP will receive reciprocal electrical stimulation in combination with neurodevelopmental approach directed toward inhibiting abnormal muscle tone and abnormal reflexes and facilitation of postural control through reflex inhibiting positions using proximal and distal key points of control.
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Mode (A) is selected to apply reciprocal neuromuscular electrical stimulation
Other Names:
Other Names:
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Sham Comparator: children diagnosed with hemiparetic CP
neurodevelopmental approach directed toward inhibiting abnormal muscle tone and abnormal reflexes and facilitation of postural control through reflex inhibiting positions using proximal and distal key points of control.
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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balance change measured by humac balance system
Time Frame: 3 monthes
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the ability to maintain a stable posture and preserve it in counter gravity position
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3 monthes
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quality of life change xby Egyptian quality of life questionnaire
Time Frame: 3 months
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change in social, psychological and physical domains
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3 months
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- cairo2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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