Neuromuscular Electrical Stimulation With and Without Constraint Induced Movement Therapy in Erb's Palsy

June 27, 2023 updated by: Riphah International University

Effects of Neuromuscular Electrical Stimulation With and Without Constraint Induced Movement Therapy on Upper Limb Function in Children With Erb's Palsy

Erb's Duchenne paralysis constitutes the single commonest form of brachial plexus injury, brachial plexus injury (BPI) is unfortunately a rather common injury in newborn children. Incidence varies between 0.15 and 3 per 1000 live births in various series and countries. The constraint-induced movement therapy (CIMT) has been used to promote functional gains in individuals with neurological dysfunctions .The constraint-induced movement therapy consists of constraining movement of the non-affected upper extremity and providing intensive training to the involved upper extremity. Neuromuscular electrical stimulation (NMES) has been used for muscle strengthening, maintenance of muscle mass and strength during prolonged periods of immobilisation, selective muscle retraining, and the control of oedema.The aim of this study is to compare the effects of Neuromuscular Electrical Stimulation with and without Constraint Induced Movement Therapy on Upper limb Function in Children with Erb's Palsy.

It is a Randomized Controlled Trial.The sample size calculated by using OpenEpi or GPower. Data will be collected from Jinnah Hospital,Children Hospital,Lahore medical city hospital,Farooq hospital,Rising sun institute and PSRD. The patients will be selected through non-probability convenience sampling,will be divided into two groups. The Group A will receive habituation exercises for six weeks, three times per week for thirty minutes, along with application of neuromuscular electrical stimulation for a period of 6 weeks four times a week and perform Constrained induced movement therapy techniques, each for 8 weeks.The interventions are consisted of 3weeks of casting the unaffected limb followed by 5 weeks of transference activities.. The Group B will be given neuromuscular electrical stimulation for a period of 6 weeks four times a week.Range of motion ,Flexibility exercises will be given as baseline treatment to both groups. The arm function was evaluated by the Mallet score system, while active abduction and external rotation range of motion were measured by a standard universal goniometer. Data will be analyzed by SPSS 25.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

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 Contact

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan
        • Jinnah 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

2 years to 6 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Aged between 2.5 to 8 years years
  • Clinically diagnosed with erb's palsy/brachial plexus palsy
  • Ability to cooperate with assessments and therapy
  • Full passive ROMs in all motions at the shoulder, elbow, and wrist joints

Exclusion Criteria:

  • Cognitive impairment
  • Contracture in the affected upper extremity
  • Injured unaffected arm
  • Visual problems likely to interfere with treatment/testing
  • Previous orthopedic or neurological surgery
  • Previous application of CIMT

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EMS with CIMT group
Other: EMS with CIMT
The interventions are consisted of 3weeks of casting the unaffected limb followed by 5 weeks of transference activities.The assisting hand assessment AHA was used to measure bimanual activity performance at baseline,8 weeks, 16 weeks. 20-minute application of currents and resistance exercises for the respective muscles of the area. The intervention group with 11 patients underwent a program of CIMT for one hour daily for 14 consecutive days or two hours per day, six days per week and a total of 12 weeks. A follow-up will be performed 12 weeks after the intervention. The healthy upper limb will be immobilized by orthosis or cast for six hours a day . Electrotherapy will be applied with TENS for 15 minutes at intervals of 1000ms and with a pulse duration of 50ms. The square wave will be chosen to ensure that there will be sufficient muscle contraction
Active Comparator: EMS Group
Other: EMS
this group will only receive baseline exercises (ROM and flexibility exercises) than apply electrical stimulations at specific motor points. Electrotherapy will be applied with TENS for 15 minutes at intervals of 1000ms and with a pulse duration of 50ms. The square wave will be chosen to ensure that there will be sufficient muscle contraction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Mallet scale Scores
Time Frame: Baseline, 8th week and 16th week
The Mallet grading remains the most commonly used system in several obstetric brachial plexus centers. One feature of the Mallet score is that each grade is translated into certain degrees of deficiencies in both shoulder abduction and external rotation.
Baseline, 8th week and 16th week
Change in Box and block test scores
Time Frame: Baseline, 8th week and 16th week
the BBT has been commonly used in the pediatric field. It is particularly suitable for children for several reasons. First, the evaluation method of the BBT examines essential components of manual dexterity for developing children, such as grasping, holdi
Baseline, 8th week and 16th week

Collaborators and Investigators

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

Sponsor

Riphah International University

Investigators

  • Principal Investigator: Muneeb Iqbal, PhD, 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)

January 13, 2023

Primary Completion (Actual)

March 1, 2023

Study Completion (Actual)

March 28, 2023

Study Registration Dates

First Submitted

January 24, 2023

First Submitted That Met QC Criteria

February 1, 2023

First Posted (Actual)

February 10, 2023

Study Record Updates

Last Update Posted (Actual)

June 28, 2023

Last Update Submitted That Met QC Criteria

June 27, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/RCR & AHS/22/0749

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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