Electromyographic Biofeedback and Physical Therapy in Upper Limb Hemiparesis (EMG-BFB)
Primary Purpose
Electromyography
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Biofeedback Electromyography
Sham Biofeedback Electromyography
Conventional Physical Therapy Treatment
Sponsored by
About this trial
This is an interventional treatment trial for Electromyography focused on measuring Brain injuries, upper extremity, biofeedback, electromyography, recovery of function
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Experimental Group
Control Group
Arm Description
protocol of Biofeedback Electromyography plus conventional physical therapy treatment
consisted of Sham- Biofeedback Electromyography plus conventional physical therapy treatment
Outcomes
Primary Outcome Measures
Fugl-Meyer Upper-Extremity Scale (FMA-UE)
Assess functionality found in the motor recruitment of the paretic shoulder muscles after brain injury
Secondary Outcome Measures
range of motion
Articular goniometer
Full Information
NCT ID
NCT02974465
First Posted
November 20, 2016
Last Updated
December 7, 2018
Sponsor
University of Alcala
1. Study Identification
Unique Protocol Identification Number
NCT02974465
Brief Title
Electromyographic Biofeedback and Physical Therapy in Upper Limb Hemiparesis
Acronym
EMG-BFB
Official Title
Electromyographic Biofeedback and Physical Therapy in Upper Limb Hemiparesis: A Randomized Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
November 2016 (undefined)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
February 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alcala
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Electromyography
Keywords
Brain injuries, upper extremity, biofeedback, electromyography, recovery of function
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
protocol of Biofeedback Electromyography plus conventional physical therapy treatment
Arm Title
Control Group
Arm Type
Sham Comparator
Arm Description
consisted of Sham- Biofeedback Electromyography plus conventional physical therapy treatment
Intervention Type
Procedure
Intervention Name(s)
Biofeedback Electromyography
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Sham Biofeedback Electromyography
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Conventional Physical Therapy Treatment
Intervention Description
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…
Primary Outcome Measure Information:
Title
Fugl-Meyer Upper-Extremity Scale (FMA-UE)
Description
Assess functionality found in the motor recruitment of the paretic shoulder muscles after brain injury
Time Frame
15 minutes
Secondary Outcome Measure Information:
Title
range of motion
Description
Articular goniometer
Time Frame
10 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Torres Lacomba, PhD
Organizational Affiliation
University of Alcalá
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
20880720
Citation
Dogan-Aslan M, Nakipoglu-Yuzer GF, Dogan A, Karabay I, Ozgirgin N. The effect of electromyographic biofeedback treatment in improving upper extremity functioning of patients with hemiplegic stroke. J Stroke Cerebrovasc Dis. 2012 Apr;21(3):187-92. doi: 10.1016/j.jstrokecerebrovasdis.2010.06.006. Epub 2010 Sep 29.
Results Reference
background
PubMed Identifier
23777436
Citation
Giggins OM, Persson UM, Caulfield B. Biofeedback in rehabilitation. J Neuroeng Rehabil. 2013 Jun 18;10:60. doi: 10.1186/1743-0003-10-60.
Results Reference
background
PubMed Identifier
25477805
Citation
De Baets L, Jaspers E, Janssens L, Van Deun S. Characteristics of neuromuscular control of the scapula after stroke: a first exploration. Front Hum Neurosci. 2014 Nov 17;8:933. doi: 10.3389/fnhum.2014.00933. eCollection 2014.
Results Reference
result
PubMed Identifier
32718746
Citation
Lirio-Romero C, Torres-Lacomba M, Gomez-Blanco A, Acero-Cortes A, Retana-Garrido A, de la Villa-Polo P, Sanchez-Sanchez B. Electromyographic biofeedback improves upper extremity function: a randomized, single-blinded, controlled trial. Physiotherapy. 2021 Mar;110:54-62. doi: 10.1016/j.physio.2020.02.002. Epub 2020 Feb 15.
Results Reference
derived
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Electromyographic Biofeedback and Physical Therapy in Upper Limb Hemiparesis
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