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

November 26, 2007
January 11, 2010
September 1999
February 2001   (final data collection date for primary outcome measure)
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 ]
Active assisted knee flexion and passive knee extension range of motion [ Time Frame: pre-op, 6 & 12 weeks post-op ]
Complete list of historical versions of study NCT00564837 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Knee flexion and extension range of motion during gait [ Time Frame: pre-op, 6 & 12 wks post-op ]
  • Sagittal plane laxity of the knee [ Time Frame: pre-op, 6 & 12 wks post-op ]
  • Isokinetic quadriceps and hamstrings strength [ Time Frame: pre-op and 12wks post-op ]
Not Provided
Not Provided
 
Home Vs. Physiotherapy Supervised Rehabilitation After ACL Reconstruction
Comparison of Home Vs. Physiotherapy-Supervised Rehabilitation Programs Following Reconstruction of the Anterior Cruciate Ligament (ACL)

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
ACL Reconstruction
  • Procedure: Home-based rehabilitation program
    Home-based rehabilitation program that includes 4 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
  • Experimental: Home-based
    Home-based post-operative rehabilitation program with 4 scheduled physiotherapy sessions over the first 3 post-op months
    Intervention: Procedure: Home-based rehabilitation program
  • Active Comparator: Physiotherapy supervised
    Physiotherapy-supervised rehabilitation program including 17 scheduled physiotherapy sessions in the first 3 post-op months
    Intervention: Procedure: Physiotherapy-supervised rehabilitation program
Grant JA, Mohtadi NG, Maitland ME, Zernicke RF. Comparison of home versus physical therapy-supervised rehabilitation programs after anterior cruciate ligament reconstruction: a randomized clinical trial. Am J Sports Med. 2005 Sep;33(9):1288-97. Epub 2005 Jul 7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
145
February 2001
February 2001   (final data collection date for primary outcome measure)

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
Both
16 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00564837
10339
No
Nicholas Mohtadi, University of Calgary Sport Medicine Centre
University of Calgary
  • Calgary Health Region
  • Olympic Oval Endowment Fund
  • AirCast LLC
  • Fitter International Inc.
Principal Investigator: Nicholas G. Mohtadi, MD, MSc University of Calgary Sport Medicine Centre
University of Calgary
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP