ACL ReconstructionNCT00564837
Home Vs. Physiotherapy Supervised Rehabilitation After ACL Reconstruction
A study testing Home-based rehabilitation program and Physiotherapy-supervised rehabilitation program in people with ACL Reconstruction, run by University of Calgary at 1 site in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- ACL Reconstruction
- What is being tested?
- Home-based rehabilitation program and Physiotherapy-supervised rehabilitation program
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 1 siteCanada
- Study dates
- Sep 1999to Feb 2001
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 16 years of age or older
- 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
- ACL reconstruction with a bone-patellar tendon-bone autograft
Who cannot join
- Previous or concomitant reconstruction of any knee ligament to either knee
- Ongoing knee abnormality unrelated to the ACL injury (eg, evidence of changes on radiographs consistent with osteoarthritis)
- Professional athletes or workers' compensation patients
- Complications during surgery (eg, inadequate graft fixation requiring protocol modification)
- Patients without access to local physical therapy services
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of Calgary Sport Medicine Centre
Calgary, Alberta, T2N 1N4
About this study
Official title: 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.
- Conditions
- ACL Reconstruction
- Being tested
- Home-based rehabilitation program, Physiotherapy-supervised rehabilitation program
- Keywords
- Anterior cruciate ligament, Reconstruction, Rehabilitation, Home-based
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based rehabilitation programProcedure or surgery
Home-based rehabilitation program that includes 4 physiotherapy sessions in the first 3 post-op months
Physiotherapy-supervised rehabilitation programProcedure or surgery
Physiotherapy-supervised rehabilitation program that includes 17 scheduled physiotherapy sessions in the first 3 post-op months
| Study group | Role | What they receive |
|---|---|---|
| Home-based | Experimental | Home-based post-operative rehabilitation program with 4 scheduled physiotherapy sessions over the first 3 post-op months Receives: Procedure: Home-based rehabilitation program |
| Physiotherapy supervised | Active comparator | Physiotherapy-supervised rehabilitation program including 17 scheduled physiotherapy sessions in the first 3 post-op months Receives: Procedure: Physiotherapy-supervised rehabilitation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Active assisted knee flexion and passive knee extension range of motion
Measured: pre-op, 6 & 12 weeks post-op
Secondary outcomes (3)
Knee flexion and extension range of motion during gait
Measured: pre-op, 6 & 12 wks post-op
Sagittal plane laxity of the knee
Measured: pre-op, 6 & 12 wks post-op
Isokinetic quadriceps and hamstrings strength
Measured: pre-op and 12wks post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2007 (estimated)
- Study startSep 1999
- Primary completionFeb 2001
- Study completionFeb 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ACL ReconstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Calgary Health Region, Olympic Oval Endowment Fund, AirCast LLC, Fitter International Inc.
- Investigators
- Nicholas G. Mohtadi, MD, MSc, Principal investigator, University of Calgary Sport Medicine Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00564837
- Sponsor's protocol ID
- 10339
- Status last verified
- Jan 2010
- First submitted
- 26 Nov 2007
- Last updated
- 12 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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. doi: 10.1177/0363546504273051. Epub 2005 Jul 7.
PubMed 16002493
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Home Vs. Physiotherapy-Supervised Rehabilitation Programs Following Reconstruction of the Anterior Cruciate Ligament (ACL)
- ClinicalTrials.gov ID
- NCT00564837
- Acronym / sponsor ID
- 10339
- Conditions
- ACL Reconstruction
- Keywords
- Anterior cruciate ligament, Reconstruction, Rehabilitation, Home-based
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Calgary Health Region, Olympic Oval Endowment Fund, AirCast LLC, Fitter International Inc.
- Study start
- Sep 1999
- Primary completion
- Feb 2001 (actual)
- Study completion
- Feb 2001 (actual)
- First posted
- 28 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home-based | Experimental | Procedure: Home-based rehabilitation programHome-based post-operative rehabilitation program with 4 scheduled physiotherapy sessions over the first 3 post-op months |
| Physiotherapy supervised | Active comparator | Procedure: Physiotherapy-supervised rehabilitation programPhysiotherapy-supervised rehabilitation program including 17 scheduled physiotherapy sessions in the first 3 post-op months |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 16 years of age or older
- 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
- ACL reconstruction with a bone-patellar tendon-bone autograft
Key exclusion criteria (5 listed)
- Previous or concomitant reconstruction of any knee ligament to either knee
- Ongoing knee abnormality unrelated to the ACL injury (eg, evidence of changes on radiographs consistent with osteoarthritis)
- Professional athletes or workers' compensation patients
- Complications during surgery (eg, inadequate graft fixation requiring protocol modification)
- Patients without access to local physical therapy services
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home-based rehabilitation programHome-based rehabilitation program that includes 4 physiotherapy sessions in the first 3 post-op months | Procedure or surgery | Home-based |
| Physiotherapy-supervised rehabilitation programPhysiotherapy-supervised rehabilitation program that includes 17 scheduled physiotherapy sessions in the first 3 post-op months | Procedure or surgery | Physiotherapy supervised |
Primary outcome
Active assisted knee flexion and passive knee extension range of motion
Time frame: pre-op, 6 & 12 weeks post-op
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2010.
- Results publication: PubMed 16002493Grant 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. doi: 10.1177/0363546504273051. Epub 2005 Jul 7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicholas G. Mohtadi, MD, MSc principal investigator
University of Calgary Sport Medicine Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based rehabilitation program and Physiotherapy-supervised rehabilitation program in people with ACL Reconstruction, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Active assisted knee flexion and passive knee extension range of motion (time frame: pre-op, 6 & 12 weeks post-op). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00564837, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2010.