Operation ACL: Rehabilitation After Anterior Cruciate Ligament Reconstruction

NCT06318039 | Not Yet Recruiting

• 1 other identifier: IRB2022-06554-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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?

Conditions

Anterior Cruciate Ligament Reconstruction

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (2)

• Knee Injury and Osteoarthritis Outcome Score (KOOS)

  Survey at 10 weeks and 8, 12, 18 and 24 months post-ACLR.

• ACL Return to Sport after Injury scale

  Survey at 10 weeks and 8, 12, 18 and 24 months post-ACLR.

Study Arms (2)

Novel program

EXPERIMENTAL

Rehabilitation using a novel program

Other: Novel program; Other: Traditional program

Traditional program

ACTIVE COMPARATOR

Rehabilitation using a traditional program

Other: Novel program; Other: Traditional program

Interventions

Novel program OTHER

Applying new training method; the Nordic hamstring exercise

Novel program; Traditional program

Traditional program OTHER

Conventional rehabilitation training administered

Novel program; Traditional program

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Athletes or recreational athletes that have undergone ACLR

You may not qualify if:

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

Sponsors & Collaborators

• Linnaeus University: lead

Study Sites (1)

Linnaeus University

Kalmar, Sverige, 39363, Sweden

Location

Related Links

• The project's homepage

Study Officials

• Jesper Augustsson, PhD

  Linneuniversitetet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jesper Augustsson, PhD

CONTACT

+46705589752; jesper.augustsson@lnu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Associate Professor

Model Details: randomized controlled trial

Study Record Dates

• First Submitted: January 3, 2024
• First Posted: March 19, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: April 8, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: From year 2026 to 2031.
• Access Criteria: Other researcher within the field of ACLR-rehabilitation.

Locations

SE (1)