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

Primary Purpose

Hamstring Injury, Muscle Rupture, Hamstring Sprain

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
NMES+
Rehab
Sponsored by
Università degli studi di Roma Foro Italico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hamstring Injury focused on measuring Electrical Muscle Stimulation (EMS), NMES+, Hamstring strain injury, Neuromuscular Electrical Stimulation (NMES)

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Treatment Group

    Control Group

    Arm Description

    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

    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.

    Outcomes

    Primary Outcome Measures

    Tear monitoring and muscle quality
    Healing status of the muscle tear (mm/cm), using ultrasounds
    Tear Monitoring
    Healing status of the muscle tear (mm/cm), using ultrasounds

    Secondary Outcome Measures

    Full Information

    First Posted
    March 1, 2023
    Last Updated
    September 25, 2023
    Sponsor
    Università degli studi di Roma Foro Italico
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05786300
    Brief Title
    Effect of NMES+ on Hamstring Lesion (3a/3b)
    Official Title
    Is Early Superimposed Neuromuscular Electrical Stimulation (NMES+) Useful to Improve Muscle Tissue Recovery From Type 3a/3b Hamstring Strain Injuries (HSI)?
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 1, 2023 (Anticipated)
    Primary Completion Date
    September 1, 2024 (Anticipated)
    Study Completion Date
    December 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Università degli studi di Roma Foro Italico

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Product Manufactured in and Exported from the U.S.
    Yes

    5. Study Description

    Brief Summary
    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].

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hamstring Injury, Muscle Rupture, Hamstring Sprain
    Keywords
    Electrical Muscle Stimulation (EMS), NMES+, Hamstring strain injury, Neuromuscular Electrical Stimulation (NMES)

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment Group
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    Control Group
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    NMES+
    Intervention Description
    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
    Procedure
    Intervention Name(s)
    Rehab
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Tear monitoring and muscle quality
    Description
    Healing status of the muscle tear (mm/cm), using ultrasounds
    Time Frame
    Baseline
    Title
    Tear Monitoring
    Description
    Healing status of the muscle tear (mm/cm), using ultrasounds
    Time Frame
    Up to 6 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Learn more about this trial

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

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