Electromyographic Biofeedback and Physical Therapy in Upper Limb Hemiparesis

NCT02974465 | Completed DMC

• 1 other identifier: UNIALCALA
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Electromyography

Keywords

Brain injuries; upper extremity; biofeedback; electromyography; recovery of function

Outcome Measures

Primary Outcomes (1)

• Fugl-Meyer Upper-Extremity Scale (FMA-UE)

  Assess functionality found in the motor recruitment of the paretic shoulder muscles after brain injury

  15 minutes

Secondary Outcomes (1)

• range of motion

  10 minutes

Study Arms (2)

Experimental Group

EXPERIMENTAL

protocol of Biofeedback Electromyography plus conventional physical therapy treatment

Procedure: Biofeedback Electromyography; Procedure: Conventional Physical Therapy Treatment

Control Group

SHAM COMPARATOR

consisted of Sham- Biofeedback Electromyography plus conventional physical therapy treatment

Procedure: Sham Biofeedback Electromyography; Procedure: Conventional Physical Therapy Treatment

Interventions

Biofeedback Electromyography PROCEDURE

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.

Experimental Group

Sham Biofeedback Electromyography PROCEDURE

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.

Control Group

Conventional Physical Therapy Treatment PROCEDURE

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…

Control Group; Experimental Group

Eligibility Criteria

• Age: 15 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Alcala: lead

Related Publications (4)

• 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.

  PMID: 20880720 BACKGROUND

• Giggins OM, Persson UM, Caulfield B. Biofeedback in rehabilitation. J Neuroeng Rehabil. 2013 Jun 18;10:60. doi: 10.1186/1743-0003-10-60.

  PMID: 23777436 BACKGROUND

• 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.

  PMID: 25477805 RESULT

• 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.

  PMID: 32718746 DERIVED

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Maria Torres Lacomba, PhD

  University of Alcalá

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist

Study Record Dates

• First Submitted: November 20, 2016
• First Posted: November 28, 2016
• Study Start: November 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: February 1, 2018
• Last Updated: December 11, 2018

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share