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
1 other identifier
interventional
28
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2017
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 8, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2018
CompletedFirst Submitted
Initial submission to the registry
February 7, 2019
CompletedFirst Posted
Study publicly available on registry
February 12, 2019
CompletedFebruary 12, 2019
February 1, 2019
4 months
February 7, 2019
February 9, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Extension Degree
Change in the extension ability of the upper an lower members depending on the activity of the extensor muscles
3 months
Secondary Outcomes (1)
Fugl Meyer Test
6 months
Study Arms (2)
INTERVENTION
EXPERIMENTALA group that underwent a neurological physiotherapy program with electromyography-biofeedback on the hand and the foot
CONTROL
ACTIVE COMPARATORA group that underwent a conventional physiotheraphy intervention
Interventions
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.
Eligibility Criteria
You may qualify if:
- Patients with a stroke
- Limitation of the hand and foot extension
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Catholic University of Murcia
Murcia, 30107, Spain
Related Publications (1)
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.
PMID: 31511629DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Juan José Hernández Morante, PhD
Catholic University of Murcia
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator of the Eating Disorders Research Unit
Study Record Dates
First Submitted
February 7, 2019
First Posted
February 12, 2019
Study Start
August 8, 2017
Primary Completion
November 30, 2017
Study Completion
June 1, 2018
Last Updated
February 12, 2019
Record last verified: 2019-02
Data Sharing
- IPD Sharing
- Will not share