Electromyographic Biofeedback and Physical Therapy in Upper Limb Hemiparesis (EMG-BFB)

December 7, 2018 updated by: Cristina Lirio Romero, University of Alcala

Electromyographic Biofeedback and Physical Therapy in Upper Limb Hemiparesis: A Randomized Controlled Clinical Trial

The aim of this study was to assess the effect of a specific protocol of sEMG-BFB in upper limb hemiparesis added to conventional physical therapy on changes in upper extremity functionality, motor recruitment pattern and range of motion (ROM) compared to the single application of conventional physical therapy. It aims to find a 22.22% difference between both interventions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Upper limb hemiparesis is a common consequence after brain damage.

Objective: To evaluate the effect of a specific protocol of surface electromyographic biofeedback (sEMG-BFB) and conventional physical therapy in upper limb functionality, muscle recruitment changes, and glenohumeral range of motion compared to the single application of conventional physical therapy.

Design: randomized controlled clinical trial.

Sample: 40 participants from State Center of Attention to Brain Injury were recruited.

Interventions: Patients were randomly assigned to 2 groups where the experimental group received sEMG-BFB for the upper trapezius and middle deltoid muscles of the upper limb with hemiparesis and the control group received a placebo of the same technique. Both treatments were applied for 6 weeks. The score of the Fugl-Meyer Assessment-Upper Extremity" for functionality and shoulder range of motion were objectified. Root mean square (RMS) value was assessed as a secondary measure Data were collected before and after intervention.

A protocol of sEMG-BFB in upper limb may have an important role in the recovery of subjects with upper limb hemiparesis.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

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

15 years to 55 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • acquired brain injury after two months of medical evolution at least;
  • suffer paretic upper limb;
  • spasticity no greater than 3 in the modified Ashworth scale;
  • minimum active ROM of 20º of glenohumeral abduction.

Exclusion Criteria:

  • peripheral nerve injury, fractures of upper limb, cervical radiculopathy, complete luxation of the shoulder and severe cognitive impairment.

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: Experimental Group
protocol of Biofeedback Electromyography plus conventional physical therapy treatment
Procedure: Biofeedback Electromyography
protocol of sEMG-BFB that consisted of active movements in glenohumeral abduction guided by the visual signal of the register equipment. The protocol was the following: firstly proof active movements were requested in glenohumeral abduction without feeling any pain in order to teach the visual signal of their muscle activity. The therapist dedicated around 10 minutes in each session for subject learned to control the activation of both muscles in the limits that physical therapist marked with each individual in particular (controlling the activation in the upper trapezius). Once integrated information, shoulder abduction were requested following 4 main principles.
Procedure: Conventional Physical Therapy Treatment
All participants received a conventional daily treatment of neurological physical therapy. Since no evidence has been found about a specific therapy that specially could benefit hemiparesis consequences, the common approach in this center consists of a combination of different specific concepts (Bobath, Brunnstrom, Rood, Johnstone, Propioceptive Neuromuscular Facilitation, Perfetti, Vojta, Motor Relearning Programme,…), exercise programs, electrotherapy, myofascial techniques, etc…
Sham Comparator: Control Group
consisted of Sham- Biofeedback Electromyography plus conventional physical therapy treatment
Procedure: Conventional Physical Therapy Treatment
All participants received a conventional daily treatment of neurological physical therapy. Since no evidence has been found about a specific therapy that specially could benefit hemiparesis consequences, the common approach in this center consists of a combination of different specific concepts (Bobath, Brunnstrom, Rood, Johnstone, Propioceptive Neuromuscular Facilitation, Perfetti, Vojta, Motor Relearning Programme,…), exercise programs, electrotherapy, myofascial techniques, etc…
Procedure: Sham Biofeedback Electromyography
consisted of Sham-EMG biofeedback, in which the electrodes were placed as the same method as the EG (Fig. 2) but the screen emit no signal. The subject performed 3 sequences of 10 abduction contractions (first degrees) without pain feeling and with 5 minutes of rest between sequences.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fugl-Meyer Upper-Extremity Scale (FMA-UE)
Time Frame: 15 minutes
Assess functionality found in the motor recruitment of the paretic shoulder muscles after brain injury
15 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
range of motion
Time Frame: 10 minutes
Articular goniometer
10 minutes

Collaborators and Investigators

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

Sponsor

University of Alcala

Investigators

  • Study Director: Maria Torres Lacomba, PhD, University of Alcala

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

November 1, 2016

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

February 1, 2018

Study Registration Dates

First Submitted

November 20, 2016

First Submitted That Met QC Criteria

November 22, 2016

First Posted (Estimate)

November 28, 2016

Study Record Updates

Last Update Posted (Actual)

December 11, 2018

Last Update Submitted That Met QC Criteria

December 7, 2018

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UNIALCALA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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