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Operation ACL: Rehabilitation After Anterior Cruciate Ligament Reconstruction

Operation ACL: Rehabilitation After Anterior Cruciate Ligament Reconstruction

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06318039
Enrollment
100
Registered
2024-03-19
Start date
2024-10-01
Completion date
2027-10-01
Last updated
2024-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anterior Cruciate Ligament Reconstruction

Brief summary

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

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.

Interventions

OTHERNovel program

Applying new training method; the Nordic hamstring exercise

Conventional rehabilitation training administered

Sponsors

Linnaeus University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

randomized controlled trial

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Athletes or recreational athletes that have undergone ACLR

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Isokinetic muscle strengthTests at 8, 12, 18 and 24 months post-ACLR.Test of each patient's unilateral maximal isokinetic muscle strength for the involved and the uninvolved leg, using an isokinetic dynamometer (Biodex isokinetic dynamometry system 4).
Single-leg hop performanceTests at 8, 12, 18 and 24 months post-ACLR.Test of each patient's single-leg hop performance for the involved and the uninvolved leg. The goal is to have a less than 10% difference in hop distance between the injured limb and uninjured limb.

Secondary

MeasureTime frameDescription
Knee Injury and Osteoarthritis Outcome Score (KOOS)Survey at 10 weeks and 8, 12, 18 and 24 months post-ACLR.Knee Injury and Osteoarthritis Outcome Score (KOOS) evaluates both short-term and long-term consequences of knee injury. It holds 42 items in 5 separately scored subscales; Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL). The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems.
ACL Return to Sport after Injury scaleSurvey at 10 weeks and 8, 12, 18 and 24 months post-ACLR.The ACL - Return to Sport after Injury (ACL-RSI) scale measure athletes' emotion, confidence, and risk appraisal when returning to sports after an ACL injury and/or reconstructive surgery. The survey consists of 12 items that are graded on a visual analogue scale from 0 points (extremely negative psychological responses) to 100 points (no negative psychological responses).

Countries

Sweden

Contacts

Primary ContactJesper Augustsson, PhD
jesper.augustsson@lnu.se+46705589752

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026