Effect of NMES+ on Hamstring Lesion (3a/3b)

NCT ID: NCT05786300

Last Updated: 2023-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2024-12-01

Brief Summary

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The goal of this clinical trial is to analyze the effect of the electrical stimulation superimposed onto movement in healthy semi-professional athletes who sustained a type 3a/3b hamstring strain injury.

The main questions it aims to answer are:

* Is NMES+ useful for the treatment of type 3a/3b hamstring strain injury?
* Does NMES+ improve the quality of the injured muscle tissue? Participants will follow a 3 week protocol, following the latest evidence available.\[describe the main tasks participants will be asked to do, treatments they'll be given and use bullets if it is more than 2 items\]. If there is a comparison group: Researchers will compare \[insert groups\] to see if \[insert effects\].

Detailed Description

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Conditions

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Hamstring Injury Muscle Rupture Hamstring Sprain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Treatment Group

The Treatment Group will follow the rehabilitation protocol with the addition of the Neuromuscular Electrical Stimulation Superimposed onto Movement (NMES+) as part of the rehabilitation protocol.

1st/2nd Week at 35 Hertz. 3rd/4th Week 50 Hertz. 5th/6th Week 70 Hertz

Group Type EXPERIMENTAL

NMES+

Intervention Type DEVICE

The Treatment Group will follow the rehabilitation protocol with the addition of the NMES+.

1st/2nd Week at 35 Hertz. 3rd/4th Week 50 Hertz. 5th/6th Week 70 Hertz.

Rehab

Intervention Type PROCEDURE

The Control Group will follow a protocol based on the latest available guidelines for the rehabilitation of the hamstrings lesions.

A weight-bearing protocol with a week by week progression on load, repetitions and sets.

Control Group

The Control Group will follow the same rehabilitation protocol with no addition of the NMES+.

A weight-bearing protocol with a week by week progression on load, repetitions and sets.

Group Type ACTIVE_COMPARATOR

Rehab

Intervention Type PROCEDURE

The Control Group will follow a protocol based on the latest available guidelines for the rehabilitation of the hamstrings lesions.

A weight-bearing protocol with a week by week progression on load, repetitions and sets.

Interventions

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NMES+

The Treatment Group will follow the rehabilitation protocol with the addition of the NMES+.

1st/2nd Week at 35 Hertz. 3rd/4th Week 50 Hertz. 5th/6th Week 70 Hertz.

Intervention Type DEVICE

Rehab

The Control Group will follow a protocol based on the latest available guidelines for the rehabilitation of the hamstrings lesions.

A weight-bearing protocol with a week by week progression on load, repetitions and sets.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* recreational or semi-professional athletes
* Body Mass Index between 18,5 e 24,9
* Hamstring strain lesion type 3a/3b

Exclusion Criteria

* previous hamstring strain lesions
* Anterior Cruciate Ligament Reconstruction using Hamstring graft
* Current hamstring strains
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Università degli studi di Roma Foro Italico

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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NMESHAMSTRING1

Identifier Type: -

Identifier Source: org_study_id

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