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Isoinertial Rehabilitation in Recovering Hamstring Strength Following Surgical Anterior Cruciate Ligament Reconstruction

Primary Purpose

ACL Injury, ACL Sprain, ACL Tear

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Isoinertial training
Strength Training
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 ACL Injury

Eligibility Criteria

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

Inclusion Criteria: having undergone ACL-R surgery following a unilateral rupture with reconstructive surgical technique using autograft tendon from the semitendinosus and gracilis muscles (ST-GR), also in the presence of meniscal injuries treated with selective meniscectomy or meniscal suturing. Participants must report a level of physical activity between 5 and 10 assessed using the Tegner scale, and have completed the third month of post-operative rehabilitation Exclusion Criteria: concurrent injuries involving other ligaments of the knee, cartilage injuries requiring surgery to repair the damage previous ACL reconstruction (re-rupture with a new ACL reconstruction) on the knee affected by the new ACL injury. Additionally, if the level of pain prevents the subject from performing the functional tests, they will not be included in the study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Gold Rehab + Strength Training

    Gold Rehab + Isoinertial

    Arm Description

    Gold standard rehabilitation plus traditional strength training with overloads

    Gold standard rehabilitation with the inclusion of isoinertial training

    Outcomes

    Primary Outcome Measures

    Active and passive range of motion (ROM) of the knee joint
    Active and passive range of motion (ROM) of the knee joint
    Strength of the thigh flexor and extensor muscles
    Strength of the thigh flexor and extensor muscles
    Qualitative analysis of the Single Leg Squat
    Qualitative analysis of the Single Leg Squat
    Maximal Hip Flexion Active Knee Extension Test
    Maximal Hip Flexion Active Knee Extension Test
    Quantitative analysis of the Drop Jump, with frontal and sagittal views
    Quantitative analysis of the Drop Jump, with frontal and sagittal views

    Secondary Outcome Measures

    Full Information

    First Posted
    July 28, 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
    NCT06063915
    Brief Title
    Isoinertial Rehabilitation in Recovering Hamstring Strength Following Surgical Anterior Cruciate Ligament Reconstruction
    Official Title
    "Efficacy of Isoinertial Rehabilitation in Recovering Hamstring Strength Following Surgical Anterior Cruciate Ligament Reconstruction: a Randomized Controlled Trial"
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 1, 2024 (Anticipated)
    Primary Completion Date
    October 31, 2024 (Anticipated)
    Study Completion Date
    October 31, 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
    No

    5. Study Description

    Brief Summary
    The present experimental study aims to evaluate the effectiveness and tolerability of isoinertial strength training of the hamstrings using machines in patients with ACL-R during the intermediate post-intervention phases.
    Detailed Description
    A proper post-operative rehabilitation program is essential for a positive outcome after anterior cruciate ligament (ACL) reconstruction surgery, a procedure known to cause morpho-functional issues in the short, medium, and long term in individuals who undergo it. Generally, after an initial rehabilitation phase focused on protecting the healing process of the new ligament and regaining range of motion, the rehabilitation path focuses on muscular strengthening and neuromuscular control of both lower limbs. It has been demonstrated that deficits in extensor and flexor muscle strength, as well as their strength ratios, increase the risk of re-injury. Specifically, in athletes, the rate of recurrence, defined as a new injury to the same or opposite side ACL, is considerably high. High-intensity resistance training of the operated limb has often been contraindicated in the early post-operative period, as it was considered detrimental to the new ligament, joint cartilage, and surrounding soft tissues. However, recent studies suggest that the early application of progressive eccentric-focused exercises, even with high loads, can be safely used to increase muscle volume and strength levels in individuals undergoing ACL reconstruction (ACL-R). Therefore, eccentric reinforcement can be a valid alternative to traditional concentric work for improving lower limb muscle strength after ACL-R. Recently, it has been demonstrated that strength training using isoinertial machines in healthy individuals leads to positive chronic adaptations in terms of strength recovery, power, and functional capacities such as sprinting, change of direction, and agility. Isoinertial training allows for exercises in both closed and open kinetic chains, as well as multiplanar motor activities. The combination of concentric phases with subsequent eccentric overload allows for the development of high levels of strength and power with low energy cost, promotes intermuscular coordination, preferentially recruits motor units with high activation thresholds, and increases cortical activity. Increased muscle activation, particularly during eccentric muscle actions, indicates a higher mechanical load and a greater training stimulus, leading to better and earlier protein synthesis and subsequent muscle hypertrophy compared to traditional resistance training. Furthermore, the metabolic cost required for an eccentric contraction is about a quarter of that for a concentric contraction at the same external load. Therefore, at the same contraction velocity, eccentric contractions allow for a higher force expression. While the use of isoinertial equipment is well-established in healthy individuals, scientific evidence regarding its use in rehabilitation protocols is currently limited. The use of eccentric overload, in addition to improving parameters related to muscle strength and power, seems to promote tendon remodeling due to an increased production of fibroblasts and collagen, generated by the higher mechanical load compared to traditional concentric exercise. In lower limb pathologies, isoinertial rehabilitation following injury can be a valid alternative to traditional strength training for the development of muscle hypertrophy and function. However, specific studies investigating the effects of isoinertial rehabilitation in the intermediate stages of recovery following ACL-R and monitoring the tolerability of the treatment are currently lacking.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    ACL Injury, ACL Sprain, ACL Tear, Anterior Cruciate Ligament Rupture, Anterior Cruciate Ligament Injuries

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    52 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Gold Rehab + Strength Training
    Arm Type
    Active Comparator
    Arm Description
    Gold standard rehabilitation plus traditional strength training with overloads
    Arm Title
    Gold Rehab + Isoinertial
    Arm Type
    Experimental
    Arm Description
    Gold standard rehabilitation with the inclusion of isoinertial training
    Intervention Type
    Device
    Intervention Name(s)
    Isoinertial training
    Intervention Description
    The subjects included in the study will undergo traditional muscle strengthening for a period of 4 weeks, with 2 sessions per week consisting of strength training using isoinertial machines
    Intervention Type
    Other
    Intervention Name(s)
    Strength Training
    Intervention Description
    The subjects included in the study will undergo traditional muscle strengthening for a period of 4 weeks, with 2 sessions per week consisting of strength training using classic exercises
    Primary Outcome Measure Information:
    Title
    Active and passive range of motion (ROM) of the knee joint
    Time Frame
    Day 0
    Title
    Active and passive range of motion (ROM) of the knee joint
    Time Frame
    Day 28
    Title
    Strength of the thigh flexor and extensor muscles
    Time Frame
    Day 0
    Title
    Strength of the thigh flexor and extensor muscles
    Time Frame
    Day 28
    Title
    Qualitative analysis of the Single Leg Squat
    Time Frame
    Day 0
    Title
    Qualitative analysis of the Single Leg Squat
    Time Frame
    Day 28
    Title
    Maximal Hip Flexion Active Knee Extension Test
    Time Frame
    Day 0
    Title
    Maximal Hip Flexion Active Knee Extension Test
    Time Frame
    Day 28
    Title
    Quantitative analysis of the Drop Jump, with frontal and sagittal views
    Time Frame
    Day 0
    Title
    Quantitative analysis of the Drop Jump, with frontal and sagittal views
    Time Frame
    Day 28

    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: having undergone ACL-R surgery following a unilateral rupture with reconstructive surgical technique using autograft tendon from the semitendinosus and gracilis muscles (ST-GR), also in the presence of meniscal injuries treated with selective meniscectomy or meniscal suturing. Participants must report a level of physical activity between 5 and 10 assessed using the Tegner scale, and have completed the third month of post-operative rehabilitation Exclusion Criteria: concurrent injuries involving other ligaments of the knee, cartilage injuries requiring surgery to repair the damage previous ACL reconstruction (re-rupture with a new ACL reconstruction) on the knee affected by the new ACL injury. Additionally, if the level of pain prevents the subject from performing the functional tests, they will not be included in the study

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Isoinertial Rehabilitation in Recovering Hamstring Strength Following Surgical Anterior Cruciate Ligament Reconstruction

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