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

Sponsor

University of Alcala (Other)

Overall Status

Completed

CT.gov ID

NCT02974465

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Electromyography	Procedure: Biofeedback Electromyography Procedure: Sham Biofeedback Electromyography Procedure: Conventional Physical Therapy Treatment	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Nov 1, 2016

Actual Primary Completion Date :

Sep 1, 2017

Actual Study Completion Date :

Feb 1, 2018

Arms and Interventions

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: 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. 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…

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: 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.

Procedure: Conventional Physical Therapy Treatment

Outcome Measures

Primary Outcome Measures

Fugl-Meyer Upper-Extremity Scale (FMA-UE) [15 minutes]
Assess functionality found in the motor recruitment of the paretic shoulder muscles after brain injury

Secondary Outcome Measures

range of motion [10 minutes]
Articular goniometer

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Alcala

Investigators

Study Director: Maria Torres Lacomba, PhD, University of Alcalá

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Cristina Lirio Romero, Physiotherapist, University of Alcala

ClinicalTrials.gov Identifier:

NCT02974465

Other Study ID Numbers:

UNIALCALA

First Posted:

Nov 28, 2016

Last Update Posted:

Dec 11, 2018

Last Verified:

Nov 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Cristina Lirio Romero, Physiotherapist, University of Alcala

Additional relevant MeSH terms:

Paresis

Study Results

No Results Posted as of Dec 11, 2018