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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06318039
Other study ID # IRB2022-06554-01
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 1, 2024
Est. completion date October 1, 2027

Study information

Verified date April 2024
Source Linnaeus University
Contact Jesper Augustsson, PhD
Phone +46705589752
Email jesper.augustsson@lnu.se
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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?


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date October 1, 2027
Est. primary completion date March 1, 2027
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Athletes or recreational athletes that have undergone ACLR Exclusion Criteria: - Patients that have undergone ACLR that are nor athletes or recreational athletes

Study Design


Related Conditions & MeSH terms

  • Anterior Cruciate Ligament Reconstruction

Intervention

Other:
Novel program
Applying new training method; the Nordic hamstring exercise
Traditional program
Conventional rehabilitation training administered

Locations

Country Name City State
Sweden Linnaeus University Kalmar Sverige

Sponsors (1)

Lead Sponsor Collaborator
Linnaeus University

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Isokinetic muscle strength 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). Tests at 8, 12, 18 and 24 months post-ACLR.
Primary Single-leg hop performance 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. Tests at 8, 12, 18 and 24 months post-ACLR.
Secondary Knee Injury and Osteoarthritis Outcome Score (KOOS) 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. Survey at 10 weeks and 8, 12, 18 and 24 months post-ACLR.
Secondary ACL Return to Sport after Injury scale 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). Survey at 10 weeks and 8, 12, 18 and 24 months post-ACLR.
See also
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Not yet recruiting NCT05619393 - Comparison of Kinematic Movements Between ACL Deficiency With ACL Reconstruction and Healthy People N/A
Completed NCT02604550 - Anterior Cruciate Ligament Pain Study Phase 4
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Recruiting NCT05152758 - STABILITY: Physical Activity Intervention at 7 Years Post-Anterior Cruciate Ligament Reconstruction N/A

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