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Not yet recruiting NCT06318039

Operation ACL: Rehabilitation After Anterior Cruciate Ligament Reconstruction

No phase Interventional Anterior Cruciate Ligament Reconstruction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Novel program, Traditional program.
Who it may be relevant to
Registry conditions: Anterior Cruciate Ligament Reconstruction. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

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

Primary outcome measures

  • Isokinetic muscle strength [Time frame: Tests at 8, 12, 18 and 24 months post-ACLR.]
  • Single-leg hop performance [Time frame: Tests at 8, 12, 18 and 24 months post-ACLR.]
Secondary outcome measures (2)
  • Knee Injury and Osteoarthritis Outcome Score (KOOS) [Time frame: Survey at 10 weeks and 8, 12, 18 and 24 months post-ACLR.]
  • ACL Return to Sport after Injury scale [Time frame: Survey at 10 weeks and 8, 12, 18 and 24 months post-ACLR.]

Eligibility criteria

Inclusion criteria

  • Athletes or recreational athletes that have undergone ACLR

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Sweden · 1 center
  • Linnaeus University — Kalmar

Identifiers

NCT: NCT06318039 · IRB2022-06554-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗