Electromyographic Biofeedback Muscle Recovery Meniscectomy

Sponsor

Western Norway University of Applied Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT05376072

Collaborator

University of Malaga (Other)

Enrollment

Location

Arm

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Electromyographic biofeedback (EMG-BF) is a therapeutic technique that has been used success-fully in rehabilitation of injuries. Although it has been applied in athletes, its use in this field is not very widespread. The objective of this study is to analyze its effectiveness in the recovery of electromyographic activity of the quadriceps after meniscectomy, evaluated through isometric contraction of the vastus lateralis. The sample comprised ten professional footballers in the Spanish League (2nd Division A) who had previously suffered a meniscus injury in their knee and had undergone a meniscectomy. The intervention consisted of EMG-BF treatment lasting between 6 and 10 sessions. The electromyographic signal was recorded using a Thought Tech-nology ProComp Infiniti 8-channel biofeedback unit with a sampling rate of 2048 sam-ples/seconds. For each session a within-subject ABA design of 6 or 10 trials per session was used, with three pre- and three post-measures, which determined the gain for each session.

Condition or Disease	Intervention/Treatment	Phase
Feedback, Psychological	Other: Electromyographic Biofeedback	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

Efficacy of Electromyographic Biofeedback in Muscle Recovery After Meniscectomy in Soccer Players

Actual Study Start Date :

Jan 1, 2018

Actual Primary Completion Date :

May 1, 2018

Actual Study Completion Date :

Jun 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental data	Other: Electromyographic Biofeedback The players performed 10 work sessions with EMG-BF. Each session was divided into three phases: (a) three trials without receiving feedback, (b) between six and ten trials with feedback of electromyographic activity, (c) three trials without feedback. In each trial, isometric contractions of the vastus lateralis were performed. During maximum effort isometric contraction, the software associated with the ProComp Infiniti biofeedback unit collects the amplitude, the mean and maximum electromyographic signal, and also the contraction and tightening times. The contrac-tion time comprises the interval between the start of the contraction and achievement of the desired muscle tension. The tightening time is the period in which the tension voluntarily reached is maintained. For this study, the maximum and mean elec-tromyographic activity values were considered, calculated during the muscle tension time and maintained during each trial.

Arm

Intervention/Treatment

Experimental: Experimental data

Other: Electromyographic Biofeedback

The players performed 10 work sessions with EMG-BF. Each session was divided into three phases: (a) three trials without receiving feedback, (b) between six and ten trials with feedback of electromyographic activity, (c) three trials without feedback. In each trial, isometric contractions of the vastus lateralis were performed. During maximum effort isometric contraction, the software associated with the ProComp Infiniti biofeedback unit collects the amplitude, the mean and maximum electromyographic signal, and also the contraction and tightening times. The contrac-tion time comprises the interval between the start of the contraction and achievement of the desired muscle tension. The tightening time is the period in which the tension voluntarily reached is maintained. For this study, the maximum and mean elec-tromyographic activity values were considered, calculated during the muscle tension time and maintained during each trial.

Outcome Measures

Primary Outcome Measures

Changes in muscle tension level [Each participant performed a total of 10 session during 5 weeks]
Using electrommiographic biofeedback device, the increase in muscle tension after isometric contraction was observed. Each player performed 10 work sessions (2 sessions per week) with EMG-BF. Each session was divided into three phases: (a) three trials without receiving feedback, (b) between six and ten trials with feedback of electromyographic activity, (c) three trials without feedback. In each trial, isometric contractions of the vastus lateralis were performed. For all sessions, each isometric contraction lasted six seconds and the participants rested for two minutes between trials to recover their contraction capacity. The sampling rate was 2048 samples per second.

Eligibility Criteria

Criteria

Ages Eligible for Study:

24 Years to 35 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion Criteria:

Partial meniscus tear
Meniscectomy

Exclusion Criteria:

Having an injury other than a partial meniscus tear

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Antonio Hernández Mendo	Málaga		Spain	29010

Sponsors and Collaborators

Western Norway University of Applied Sciences
University of Malaga

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Coral Falco, Principal Investigator, Western Norway University of Applied Sciences

ClinicalTrials.gov Identifier:

NCT05376072

Other Study ID Numbers:

Biofeedback_UMA-WNUAS_2022

First Posted:

May 17, 2022

Last Update Posted:

May 17, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of May 17, 2022