Effect of TENS in Children With Spastic Cerebral Palsy

March 31, 2023 updated by: Amgad Elwy Ali Hussein, Cairo University

Immediate Effect of Transcutaneous Electrical Nerve Stimulation on Muscle Tone in Children With Spastic Cerebral Palsy

TENS is cheap and simple tool for physiotherapist, free of many side effects compared with other tools. so The aim of study was record the effect of TENS on calf muscle tone in spastic cerebral palsy children.

Study Overview

Status

Recruiting

Conditions

Detailed Description

The Significance of this study is to determine whether TENS could have an immediate effect on reduction of spasticity in children diagnosed with spastic cerebral palsy by studying the change of spasticity of ankle plantarflexors immediately after applying TENS to the ankle dorsiflexors.

Muscle tone assessment will be applied before and after the application using objective tool which is electromyography and subjectively by using modified Ashworth scale and goniometer, to be insured is there is an immediate effect of TENS on muscle tone of calf muscle or not.

Study Type

Observational

Enrollment (Anticipated)

22

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Dokki
      • Giza, Dokki, Egypt, 3387722
        • Recruiting
        • Faculty of Physical Therapy Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

children diagnosed with spastic cerebral palsy diplgeia of both sexes will be selected from El-Menshawy public governmental hospital in Tanta City following the official rules and after gaining the agreements of the parents and explaining the aim and procedures of the study.

Description

Inclusion Criteria:

  • The children will be included in this study is according to the following criteria

    1. Cerebral palsy spastic diaplegia.
    2. Their age ranged from 3-10 years.
    3. Both Sexes were included.
    4. The subjects with mild to moderate muscle tone according to MAS in which mild is 1 and 1+ , and moderate is 2.

Exclusion Criteria:

  • The subject will be excluded if he/she has one or more of the following criteria:

    1. Children with a history of seizures.
    2. Children who could not lie prone for any cause.
    3. Children who could not react to pain.
    4. Children who had applied any surgical procedure which affect muscle tone or any inhibitory injections like BOTOX.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
study group
in which TENS application will be applied
Control group
placebo treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MUSCLE TONE that will be measured subjectively by modified ashwoth scale
Time Frame: Baseline
the study will assess if TENS have effect on muscle tone or not the tone will be measured subjectivly by using modified ashworth scale . The Modified Ashworth scale evaluation involves the rater manually moving a limb through the range of motion to passively stretch specific muscle groups and a six-point ordinal scale for grading the resistance encountered during such passive muscle stretching. MAS grades of spasticity are as follows: 0 = normal muscle tone; 1=slight increase in muscle tone, manifested by catch and release or by minimal resistance at the end; 1+=slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout; 2=more marked increase in muscle tone, but limb easily flexed; 3=considerable increase in muscle tone, passive movement difficult; and 4 = limb rigid in flexion or extension.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Director: Asmaa Osama Sayed, Phd, Assistant Professor at Cairo university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 30, 2022

Primary Completion (Anticipated)

May 1, 2023

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

November 21, 2022

First Submitted That Met QC Criteria

December 12, 2022

First Posted (Actual)

December 14, 2022

Study Record Updates

Last Update Posted (Actual)

April 4, 2023

Last Update Submitted That Met QC Criteria

March 31, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TENS IN CP CHILDREN

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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