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

NCT06332729 | Completed

• 1 other identifier: EG,KFS,lab reserach 6
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cerebral Palsy

Keywords

cerebral palsy; universal exercise unit; functional electrical stimulation; diplegic; genu recurvatum

Outcome Measures

Primary Outcomes (3)

• muscle strength using muscle tester device

  Muscle strength can be measured by estimating a person's one repetition maximum (1RM) - a measurement of the greatest load (in kg) that can be fully moved (lifted, pushed, or pulled) once without failure -For both tests each child will perform three corrected trials and the average will be taken in analysis

  3 months

• Range of motion using kinoviea software and digital goniometer

  \- Kinovea is a free 2D motion analysis software that enables the establishment of kinematics parameters. This low-cost technology has been used in sports sciences, as well as clinical field and research work. Kinovea is a free, reliable tool that produces valid data, providing an acceptable level of accuracy in angular and linear measurements obtained via digitization of x- and y axis coordinates an angle measured in degrees (°)through which a joint moves away from a reference position

  3 months

• range of motion for the joint using digital geniometer

  measure the angle of the joint by degree (°)

  3 months

Study Arms (2)

effect of universal exercis unit on genu recurvatum in diplegic cerbral palsy children

ACTIVE COMPARATOR

Universal exercise unit (UEU) consists of system of pulleys, suspensions, belts for supporting and elastic cords. UEU is based on the concept of unloading the body against gravity and to perform movement of weak part of the body. Therapist's hands are free to provide adequate support as required by the patient during exercise training Universal exercise unit, therapy sessions extended are from three to four hours Children and adults have neurological conditions can used. Spider cage is made of metal could be depending on population pediatric or adults. Elastic resistance of cords used to increase strengthen of muscle

Device: universal exercis unit

effect of functional electrical stimulation on genu recurvatum in diplegic cerbral palsy children

ACTIVE COMPARATOR

Functional electrical stimulation (FES) is defined as the electrical stimulation of muscles that have impaired motor control to produce a contraction to obtain functional useful movement

Device: functional electrical stimulation

Interventions

universal exercis unit DEVICE

Universal exercise unit (UEU) consists of system of pulleys, suspensions, belts for supporting and elastic cords. UEU is based on the concept of unloading the body against gravity and to perform movement of weak part of the body. Therapist's hands are free to provide adequate support as required by the patient during exercise training Universal exercise unit, therapy sessions extended are from three to four hours Children and adults have neurological conditions can used. Spider cage is made of metal could be depending on population pediatric or adults. Elastic resistance of cords used to increase strengthen of muscle

effect of universal exercis unit on genu recurvatum in diplegic cerbral palsy children

functional electrical stimulation DEVICE

Functional electrical stimulation (FES) is defined as the electrical stimulation of muscles that have impaired motor control to produce a contraction to obtain functional useful movement

effect of functional electrical stimulation on genu recurvatum in diplegic cerbral palsy children

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Their age will be ranged from four to eight years.
• Their grade of spasticity will be from 1 to 1+ according to Modified Ashworth scale
• They will be on Level I and II according to Gross Motor Functional Classification System (GMFCS)
• The child will be able to follow verbal commands and instructions.

You may not qualify if:

• \- The children will be excluded if they have one of the following:
• Previous neurological or orthopedic surgery in the lower extremities.
• Botox injection in the lower extremities in the past 6 months. 4-Fixed deformity in the joints of lower limb.
• Genu recarvatum secondary to surgery 6- Severe hearing and visual defect.

Sponsors & Collaborators

• Mahmoud Reda Elsharkawy: lead

Study Sites (1)

Physical Therapy

Kafr ash Shaykh, Egypt

Location

Related Publications (1)

• Elsharkawy MR, Sherif AEA, Sarhan EE, El-Agamy OA, Elsebahy SY. Effect of Universal Exercise Unit Versus Functional Electrical Stimulation on Genu Recurvatum in Diplegic Cerebral Palsy Children. J Musculoskelet Neuronal Interact. 2025 Mar 1;25(1):109-118. doi: 10.22540/JMNI-25-109.

  PMID: 40024234 DERIVED

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Mahmoud R Elsharkawy, bachelor

  Demonstrator of physical therapy at Alsalam university

  PRINCIPAL INVESTIGATOR

• Abd Elaziz Ali sherif, PHD

  professor of pediatric department Faculty of physical therapy

  STUDY CHAIR

• Osama Abd Elfattah El-Agamy, PHD

  Professor and head of department of pediatric faculty of medicine

  STUDY CHAIR

• Sara Y Abdel Elglil Elsebahy

  Lecturer of pediatric department Faculty of physical therapy

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Demonstrator of pediatric department of physical therapy at Alsalam university

Study Record Dates

• First Submitted: March 15, 2024
• First Posted: March 27, 2024
• Study Start: February 1, 2024
• Primary Completion: May 15, 2024
• Study Completion: June 15, 2024
• Last Updated: July 15, 2024

Record last verified: 2024-07

Locations

EG (1)