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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
University of Alcala
About
Eligibility
Locations
Arms
Outcomes
Full info

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

15 Years - 55 Years (Child, Adult)All SexesDoes not accept 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.

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

    First Posted
    November 20, 2016
    Last Updated
    December 7, 2018
    Sponsor
    University of Alcala
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    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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