Home Vs. Physiotherapy Supervised Rehabilitation After ACL Reconstruction

This study has been completed.
Sponsor:
Collaborators:
Calgary Health Region
Olympic Oval Endowment Fund
AirCast LLC
Fitter International Inc.
Information provided by:
University of Calgary
ClinicalTrials.gov Identifier:
NCT00564837
First received: November 26, 2007
Last updated: January 11, 2010
Last verified: January 2010
  Purpose

This study was designed to determine whether or not there were any differences in knee range of motion, both statically and during gait, sagittal plane knee laxity, and quadriceps and hamstrings strength in patients three months post-ACL reconstruction with a bone-patellar tendon-bone autograft based on their performance of a primarily home based rehabilitation program or a standard physiotherapy-supervised program.


Condition Intervention
ACL Reconstruction
Procedure: Home-based rehabilitation program
Procedure: Physiotherapy-supervised rehabilitation program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Home Vs. Physiotherapy-Supervised Rehabilitation Programs Following Reconstruction of the Anterior Cruciate Ligament (ACL)

Resource links provided by NLM:


Further study details as provided by University of Calgary:

Primary Outcome Measures:
  • Active assisted knee flexion and passive knee extension range of motion [ Time Frame: pre-op, 6 & 12 weeks post-op ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Knee flexion and extension range of motion during gait [ Time Frame: pre-op, 6 & 12 wks post-op ] [ Designated as safety issue: No ]
  • Sagittal plane laxity of the knee [ Time Frame: pre-op, 6 & 12 wks post-op ] [ Designated as safety issue: No ]
  • Isokinetic quadriceps and hamstrings strength [ Time Frame: pre-op and 12wks post-op ] [ Designated as safety issue: No ]

Enrollment: 145
Study Start Date: September 1999
Study Completion Date: February 2001
Primary Completion Date: February 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Home-based
Home-based post-operative rehabilitation program with 4 scheduled physiotherapy sessions over the first 3 post-op months
Procedure: Home-based rehabilitation program
Home-based rehabilitation program that includes 4 physiotherapy sessions in the first 3 post-op months
Active Comparator: Physiotherapy supervised
Physiotherapy-supervised rehabilitation program including 17 scheduled physiotherapy sessions in the first 3 post-op months
Procedure: Physiotherapy-supervised rehabilitation program
Physiotherapy-supervised rehabilitation program that includes 17 scheduled physiotherapy sessions in the first 3 post-op months

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 16 years of age or older
  2. Surgery at least 6 weeks after injury to allow for a return of full range of motion, minimize swelling, and offset strength deficits due to pain/swelling14,28
  3. ACL reconstruction with a bone-patellar tendon-bone autograft

Exclusion Criteria:

  1. Previous or concomitant reconstruction of any knee ligament to either knee
  2. Ongoing knee abnormality unrelated to the ACL injury (eg, evidence of changes on radiographs consistent with osteoarthritis)
  3. Professional athletes or workers' compensation patients
  4. Complications during surgery (eg, inadequate graft fixation requiring protocol modification)
  5. Patients without access to local physical therapy services
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00564837

Locations
Canada, Alberta
University of Calgary Sport Medicine Centre
Calgary, Alberta, Canada, T2N 1N4
Sponsors and Collaborators
University of Calgary
Calgary Health Region
Olympic Oval Endowment Fund
AirCast LLC
Fitter International Inc.
Investigators
Principal Investigator: Nicholas G. Mohtadi, MD, MSc University of Calgary Sport Medicine Centre
  More Information

Publications:
Responsible Party: Nicholas Mohtadi, University of Calgary Sport Medicine Centre
ClinicalTrials.gov Identifier: NCT00564837     History of Changes
Other Study ID Numbers: 10339
Study First Received: November 26, 2007
Last Updated: January 11, 2010
Health Authority: Canada: Health Canada

Keywords provided by University of Calgary:
Anterior cruciate ligament
Reconstruction
Rehabilitation
Home-based

ClinicalTrials.gov processed this record on July 24, 2014