Feedback, PsychologicalNCT05376072
Electromyographic Biofeedback Muscle Recovery Meniscectomy
A study testing Electromyographic Biofeedback in people with Feedback, Psychological, run by Western Norway University of Applied Sciences at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 24 to 35 years, men only
- Conditions the study is for
- Feedback, Psychological
- What is being tested?
- Electromyographic Biofeedback
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2018to 1 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 35 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Partial meniscus tear
- Meniscectomy
Who cannot join
- Having an injury other than a partial meniscus tear
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Electromyographic Biofeedback in Muscle Recovery After Meniscectomy in Soccer Players
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.
- Conditions
- Feedback, Psychological
- Being tested
- Electromyographic Biofeedback
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electromyographic BiofeedbackOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental data | Experimental | Not described Receives: Other: Electromyographic Biofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Each participant performed a total of 10 session during 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2022
- Study start1 Jan 2018
- Primary completion1 May 2018
- Study completion1 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Feedback, PsychologicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western Norway University of Applied Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- University of Malaga
- Responsible party
- Principal investigator, Coral Falco, Western Norway University of Applied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05376072
- Sponsor's protocol ID
- Biofeedback_UMA-WNUAS_2022
- Status last verified
- May 2022
- First submitted
- 2 May 2022
- Last updated
- 17 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Electromyographic Biofeedback in Muscle Recovery After Meniscectomy in Soccer Players
- ClinicalTrials.gov ID
- NCT05376072
- Acronym / sponsor ID
- Biofeedback_UMA-WNUAS_2022
- Conditions
- Feedback, Psychological
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Western Norway University of Applied SciencesUniversity, hospital or other
- Collaborators
- University of Malaga
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 17 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental data | Experimental | Other: Electromyographic Biofeedback |
Who may qualify
- Ages
- 24 to 35 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Partial meniscus tear
- Meniscectomy
Key exclusion criteria (1 listed)
- Having an injury other than a partial meniscus tear
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electromyographic BiofeedbackThe 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. | Other | Experimental data |
Primary outcome
Changes in muscle tension level
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electromyographic Biofeedback in people with Feedback, Psychological, run by Western Norway University of Applied Sciences at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in muscle tension level (time frame: Each participant performed a total of 10 session during 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2022.