CClinicalTrials.gg
CompletedNCT03838809EMGBIO-ICTUSUpdated Feb 12, 2019

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

An interventional study of surface electromyography-biofeedback in Stroke, Complication, sponsored by Universidad Católica San Antonio de Murcia. Completed at 1 site in Spain. Open to participants aged 74 Years to 84 Years. Per ClinicalTrials.gov, last updated 2019-02-12.

Sponsored by Universidad Católica San Antonio de Murcia · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 1 year 5 months after the study started (first participant enrolled Aug 2017, registered Feb 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
28
Allocation
Randomized
Ages
74 Years to 84 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Stroke, Complication
03

In context

Lead sponsor

Universidad Católica San Antonio de Murcia is the lead sponsor of 132 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
74 Years to 84 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
28 participants (actual)

Study arms

  • Experimental
    INTERVENTION

    A group that underwent a neurological physiotherapy program with electromyography-biofeedback on the hand and the foot

    Device: surface electromyography-biofeedback

  • Active comparator
    CONTROL

    A group that underwent a conventional physiotheraphy intervention

    Device: surface electromyography-biofeedback

Interventions

  • Devicesurface 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.

06

What researchers measure

Primary outcomes

  1. Extension Degree

    Change in the extension ability of the upper an lower members depending on the activity of the extensor muscles

    Time frame: 3 months

Secondary outcomes

  1. Fugl Meyer Test

    Severity degree of the stroke-derived consequences

    Time frame: 6 months

07

Study locations

1 site
  • Catholic University of Murcia
    Murcia, 30107, Spain
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References and documents

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. PubMed 31511629 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 12, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03838809
Lead sponsor
Universidad Católica San Antonio de Murcia
Responsible party
Juan Jose Hernández Morante (Principal Investigator of the Eating Disorders Research Unit, Universidad Católica San Antonio de Murcia) — Principal investigator
First posted
Feb 12, 2019
Start date
Aug 8, 2017
Primary completion
Nov 30, 2017
Completion
Jun 1, 2018
Last update
Feb 12, 2019

Study contacts

Juan José Hernández Morante, PhD
principal investigator · Catholic University of Murcia

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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