Electromyography-biofeedback on the Motor Activation of the Extension of the Hand (EMGBIO-ICTUS)

Effect of a Neurological Physiotherapy Program With Electromyography-biofeedback on the Motor Activation of the Extension of the Hand and Dorsiflexion of the Foot in Cerebrovascular Damage: A Randomized Clinical Trial

Background: Biofeedback-Surface electromyography (BIO-SEMG) is a relatively recent physiotherapy technique. Although its use is widespread in sports science and sports performance, its use for the rehabilitation of patients with neurological pathologies is less studied.

Objective: The purpose of this research was to determine the changes that occur in the application of BIO-SEMG in the muscles responsible for the extension and the dorsiflexion of the hand and the foot in subjects with cerebrovascular damage.

Design: A randomized, double-blind, two-arm parallel group study was performed.

Patients: A sample of 28 subjects with limited extension of the hand and dorsiflexion of the foot as a consequence of a stroke was randomized divided in intervention or control groups.

Methods: The subjects of the intervention group underwent 12 sessions of BIO-SEMG, of 15-minute duration each of them, in the upper and lower members. On the other hand, the control group underwent another 12 sessions of 15-minute duration, in which manual physiotherapy techniques were performed.

Study Overview

• Status: Completed
• Conditions: Stroke, Complication
• Intervention / Treatment: Device: surface electromyography-biofeedback

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Murcia, Spain, 30107
    • Catholic University of Murcia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 74 years to 84 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with a stroke
• Limitation of the hand and foot extension

Exclusion Criteria:

• Patients with some contraindication against the surface electromyography biofeedback technique, for instance, people with pacemaker, with cardiovascular antecedents, etc.
• Patients receiving other physiotherapy treatment 2 months before the beginning of the study
• Patients that decline to sign the informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: INTERVENTION; A group that underwent a neurological physiotherapy program with electromyography-biofeedback on the hand and the foot	Device: surface electromyography-biofeedback; Two electrodes were putted on the motor point of the extensor muscle of the hand and the foot. The positive electrode was placed on the distal zone of the hand or the foot, while the negative electrode was placed on the proximal zone.
Active Comparator: CONTROL; A group that underwent a conventional physiotheraphy intervention	Device: surface electromyography-biofeedback; Two electrodes were putted on the motor point of the extensor muscle of the hand and the foot. The positive electrode was placed on the distal zone of the hand or the foot, while the negative electrode was placed on the proximal zone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Extension Degree	Change in the extension ability of the upper an lower members depending on the activity of the extensor muscles	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fugl Meyer Test	Severity degree of the stroke-derived consequences	6 months

Collaborators and Investigators

• Sponsor: Universidad Católica San Antonio de Murcia
• Investigators: Principal Investigator: Juan José Hernández Morante, PhD, Catholic University of Murcia

Publications and helpful links

General Publications

• Gamez AB, Hernandez Morante JJ, Martinez Gil JL, Esparza F, Martinez CM. The effect of surface electromyography biofeedback on the activity of extensor and dorsiflexor muscles in elderly adults: a randomized trial. Sci Rep. 2019 Sep 11;9(1):13153. doi: 10.1038/s41598-019-49720-x.

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2017
• Primary Completion (Actual): November 30, 2017
• Study Completion (Actual): June 1, 2018

Study Registration Dates

• First Submitted: February 7, 2019
• First Submitted That Met QC Criteria: February 9, 2019
• First Posted (Actual): February 12, 2019

Study Record Updates

• Last Update Posted (Actual): February 12, 2019
• Last Update Submitted That Met QC Criteria: February 9, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: UCAM/UITA/03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No