NCT03838809

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 7, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 12, 2019

Completed
Last Updated

February 12, 2019

Status Verified

February 1, 2019

Enrollment Period

4 months

First QC Date

February 7, 2019

Last Update Submit

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

EXPERIMENTAL

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

Device: surface electromyography-biofeedback

CONTROL

ACTIVE COMPARATOR

A group that underwent a conventional physiotheraphy intervention

Device: surface electromyography-biofeedback

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.

CONTROLINTERVENTION

Eligibility Criteria

Age74 Years - 84 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

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

Location

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.

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Juan José Hernández Morante, PhD

    Catholic University of Murcia

    PRINCIPAL INVESTIGATOR

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

Locations