Operation ACL: Rehabilitation After Anterior Cruciate Ligament Reconstruction

NCT ID: NCT06318039

Last Updated: 2024-04-08

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-01

Study Completion Date

2027-10-01

Brief Summary

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Scientific Research Question

Overall Purpose:

Regarding rehabilitation after anterior cruciate ligament reconstruction (ACLR), there is a knowledge gap - a lack of evidence. Important questions such as how rehabilitation should be structured, what it should include, and how it should be evaluated are currently not clear. Therefore, the investigators plan to conduct a two-year follow-up randomized controlled trial (RCT) on post-ACLR rehabilitation.

Moreover, detailed information on how/under what circumstances the ACL injury occurred is not satisfactorily described in the literature. Therefore, the investigators are planning a new survey that can identify, explain, and prevent the risk factors causing a person to suffer from an anterior cruciate ligament injury.

Specific Objectives:

How should guidelines for rehabilitation after ACLR be structured, what should they include, and how should they be evaluated to best restore knee function in the patient? Can a detailed and comprehensive survey identify, explain, and prevent the risk factors causing a person to suffer from an ACL injury?

Detailed Description

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The overall aim of the project is to improve the physiotherapeutic guidelines to enhance the quality of rehabilitation for patients with surgically repaired anterior cruciate ligament (ACL) injuries. ACL injury is a severe knee injury that often prevents young individuals from continuing sports activities at their desired level. It can eventually lead to knee osteoarthritis within 10-15 years after the initial injury. Despite existing research on preventive training for young athletes in high-risk sports such as soccer, handball, and floorball, this injury remains common. ACL injury in young female athletes engaged in contact sports is 2-5 times more prevalent compared to young males. Regarding rehabilitation after ACL reconstruction, literature often indicates inadequacies where full muscle strength or jumping ability has not been regained. Despite this, patients often return to sports activities, which may increase the risk of re-injury. Guidelines for structuring rehabilitation, its content, and evaluation need improvement accordingly.

Conditions

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Anterior Cruciate Ligament Reconstruction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Novel program

Rehabilitation using a novel program

Group Type EXPERIMENTAL

Novel program

Intervention Type OTHER

Applying new training method; the Nordic hamstring exercise

Traditional program

Intervention Type OTHER

Conventional rehabilitation training administered

Traditional program

Rehabilitation using a traditional program

Group Type ACTIVE_COMPARATOR

Novel program

Intervention Type OTHER

Applying new training method; the Nordic hamstring exercise

Traditional program

Intervention Type OTHER

Conventional rehabilitation training administered

Interventions

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Novel program

Applying new training method; the Nordic hamstring exercise

Intervention Type OTHER

Traditional program

Conventional rehabilitation training administered

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Athletes or recreational athletes that have undergone ACLR

Exclusion Criteria

* Patients that have undergone ACLR that are nor athletes or recreational athletes
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Linnaeus University

OTHER

Sponsor Role lead

Responsible Party

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Jesper Augustsson

PhD, Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jesper Augustsson, PhD

Role: PRINCIPAL_INVESTIGATOR

Linneuniversitetet

Locations

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Linnaeus University

Kalmar, Sverige, Sweden

Site Status

Countries

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Sweden

Central Contacts

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Jesper Augustsson, PhD

Role: CONTACT

+46705589752

Related Links

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Other Identifiers

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IRB2022-06554-01

Identifier Type: -

Identifier Source: org_study_id

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