Pure Global

Universal Exercise Unit Versus Functional Electrical Stimulation On Genu Recurvatum In Diplegic Cerebral Palsy - Trial NCT06332729

Access comprehensive clinical trial information for NCT06332729 through Pure Global AI's free database. This phase not specified trial is sponsored by Mahmoud Reda Elsharkawy and is currently Recruiting. The study focuses on Cerebral Palsy. Target enrollment is 32 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.

Free Database
Powered by Pure Global AI
840K+ Trials
Device Trial
NCT06332729
Recruiting
Device Trial
device
Trial Details
ClinicalTrials.gov โ€ข NCT06332729
View on ClinicalTrials.gov
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Universal Exercise Unit Versus Functional Electrical Stimulation On Genu Recurvatum In Diplegic Cerebral Palsy
Effect of Universal Exercise Unit Versus Functional Electrical Stimulation On Genu Recurvatum In Diplegic Cerebral Palsy Children

Study Focus

Cerebral Palsy

universal exercis unit

Interventional

device

Sponsor & Location

Mahmoud Reda Elsharkawy

Kafrelsheikh University

Kafr Ash Shaykh, Egypt

Timeline & Enrollment

N/A

Feb 01, 2024

Jun 15, 2024

32 participants

Primary Outcome

muscle strength using muscle tester device,Range of motion using kinoviea software and digital goniometer,range of motion for the joint using digital geniometer

Summary

Summary:
 
 Inclusion Criteria:
 
 - Children aged four to eight years.
 
 - Grade of spasticity ranging from 1 to 1+ on the Modified Ashworth scale.
 
 - Classified as Level I or II on the Gross Motor Functional Classification System (GMFCS).
 
 - Ability to follow verbal commands and instructions.
 
 Exclusion Criteria:
 
 - Previous neurological or orthopedic surgery in the lower extremities.
 
 - Botox injection in the lower extremities within the past six months.
 
 - Fixed deformity in the joints of the lower limb.
 
 - Genu recarvatum secondary to surgery.
 
 - Severe hearing and visual defects.
 
 Materials for Subject Selection and Evaluation:
 
 - Modified Ashworth Scale for muscle tone assessment.
 
 - Gross Motor Functional Classification System (GMFCS) for functional activity
 classification.
 
 - Digital goniometer for measuring the angle of knee hyperextension.
 
 - Lafayette Manual Muscle Tester for quantifying muscle strength.
 
 Methods:
 
 - Assessment of muscle tone using the Modified Ashworth Scale, evaluating spasticity in
 calf muscles and hip/knee extensors.
 
 - Evaluation of gross motor function using the GMFCS.
 
 - Assessment of genu recarvatum using a digital goniometer.
 
 - Assessment of muscle strength using the Lafayette Manual Muscle Tester, focusing on
 hamstrings and tibialis anterior muscles.
 
 - Assessment of range of motion in the knee joint using Kinovea software.
 
 - Treatment procedures involving physical therapy sessions with a combination of exercises
 and interventions tailored to each group (Group A and Group B).
 
 Group A Treatment:
 
 - Designed physical therapy program combined with pulley therapy for muscle strengthening.
 
 Group B Treatment:
 
 - Designed physical therapy program combined with functional electrical stimulation during
 walking on a treadmill for muscle stimulation.
 
 The interventions in both groups aim to improve muscle strength, range of motion, and
 functional abilities in children with cerebral palsy.

ICD-10 Classifications

Cerebral palsy
Other cerebral palsy
Cerebral palsy, unspecified
Dyskinetic cerebral palsy
Ataxic cerebral palsy

Data Source

ClinicalTrials.gov

NCT06332729

Device Trial