Operation ACL: Rehabilitation After Anterior Cruciate Ligament Reconstruction
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorLinnaeus University
About this trial
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?
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Athletes or recreational athletes that have undergone ACLR
Disqualifiers
Patients that have undergone ACLR that are nor athletes or recreational athletes
Trial design
Design model
Parallel
Treatments tested in this trial
Novel program
Other interventionApplying new training method; the Nordic hamstring exercise
Traditional program
Other interventionConventional rehabilitation training administered
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Novel programExperimental treatment 2 interventions
Group B: Traditional programActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
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).
Time frame
Tests at 8, 12, 18 and 24 months post-ACLR.2
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.
Time frame
Tests at 8, 12, 18 and 24 months post-ACLR.Secondary outcomes
1
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.
Time frame
Survey at 10 weeks and 8, 12, 18 and 24 months post-ACLR.2
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).
Time frame
Survey at 10 weeks and 8, 12, 18 and 24 months post-ACLR.Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: