Electromyography-biofeedback on the Motor Activation of the Extension of the Hand

Stroke, Complication Clinical Trial

— EMGBIO-ICTUS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03838809
• Other study ID #: UCAM/UITA/03
• Status: Completed
• Phase: N/A
• Start date: August 8, 2017
• Est. completion date: June 1, 2018

Study information

• Verified date: February 2019
• Source: Universidad Católica San Antonio de Murcia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: June 1, 2018
• Est. primary completion date: November 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 74 Years to 84 Years

Eligibility

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.

Related Conditions & MeSH terms

• Stroke, Complication

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.

Locations

Country	Name	City	State
Spain	Catholic University of Murcia	Murcia

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Católica San Antonio de Murcia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Extension Degree	Change in the extension ability of the upper an lower members depending on the activity of the extensor muscles	3 months
Secondary	Fugl Meyer Test	Severity degree of the stroke-derived consequences	6 months