NCT05376072

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2018

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

January 1, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

May 2, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 17, 2022

Completed
Last Updated

May 17, 2022

Status Verified

May 1, 2022

Enrollment Period

4 months

First QC Date

May 2, 2022

Last Update Submit

May 10, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Changes in muscle tension level

    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.

    Each participant performed a total of 10 session during 5 weeks

Study Arms (1)

Experimental data

EXPERIMENTAL
Other: Electromyographic Biofeedback

Interventions

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.

Experimental data

Eligibility Criteria

Age24 Years - 35 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Partial meniscus tear
  • Meniscectomy

You may not qualify if:

  • Having an injury other than a partial meniscus tear

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Antonio Hernández Mendo

Málaga, 29010, Spain

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 2, 2022

First Posted

May 17, 2022

Study Start

January 1, 2018

Primary Completion

May 1, 2018

Study Completion

June 1, 2018

Last Updated

May 17, 2022

Record last verified: 2022-05

Locations