Functional Electrical Stimulation On Functional Rehabilitation In Children With Erb's Palsy

February 20, 2023 updated by: Riphah International University

Effects Of Functional Electrical Stimulation On Functional Rehabilitation In Children With Erb's Palsy

Erb's palsy is a type of brachial plexus injury occurs in infants due to injury of nerves during childbirth. Injury causes weakness or paralysis of different muscles. Different type of approaches are made for the treatment of erb;s palsy such passive range of motion, stretching ,splinting ,electrotherapy etc. In erb's palsy the most affected ranges are shoulder abduction and shoulder external rotation. Quasi experimental study will be done on the patient with erb's palsy intervention applied will be functional electrical stimulation (a low frequency current) applied 5 day a weeks for 2 weeks than on alternate days for the rest of the treatment. Setting for functional electrical stimulation will be Frequency 20 pps with Pulse width of 300 msec. 18 patient will be recruited . "Assumed population standard deviation"4.24" "Confidence level""0.95" "Acceptable error""2". Pre-intervention reading will be taken on modified mallet scale and universal goniometer and post intervention measurement will be taken after 02, 04 ,06 months.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Pakistan
    • Punjab
      • Faisalābad, Punjab, Pakistan, 38000
        • Children Complex Hospital

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

1 year to 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosed with Erb's Palsy
  • Children of age 15 months to 3 years

Exclusion Criteria:

  • hemiplegic cerebral palsy
  • children with upper limb fractures
  • obstetrical brachial plexus injury
  • upper limb contracture

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

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Functional Electrical Stimulation
functional electrical stimulation with Frequency 20 pps with Pulse width of 300 msec.
Other: Functional Electrical Stimulation
functional electrical stimulation with Frequency 20 pps with Pulse width of 300 msec.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Modified mallet scale Score
Time Frame: Baseline, 2nd, 4th and 6th Months
Modified Mallet scale evaluation of function and arm appearance. In addition to assessing the classical shoulder functions of the classical Modified Mallet system, supination and the resting position are evaluated. In the resting position, medial rotation at the shoulder is scored on a scale of 1 to 5. 1 is the lowest score and 5 is the highest score
Baseline, 2nd, 4th and 6th Months
Change in range of motion
Time Frame: Baseline, 2nd, 4th and 6th months

A goniometer is an instrument that measures the available range of motion at a joint. The art and science of measuring the joint ranges in each plane of the joint are called goniometry.

To measure the range of motion physical therapists most commonly use a goniometer.
Baseline, 2nd, 4th and 6th months

Collaborators and Investigators

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

Sponsor

Riphah International 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, 2021

Primary Completion (Actual)

June 30, 2022

Study Completion (Actual)

July 31, 2022

Study Registration Dates

First Submitted

April 2, 2022

First Submitted That Met QC Criteria

April 15, 2022

First Posted (Actual)

April 19, 2022

Study Record Updates

Last Update Posted (Estimate)

February 21, 2023

Last Update Submitted That Met QC Criteria

February 20, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/RCR &AHS/21/0701

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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