- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01555307
Effectiveness of Exercise Programs Following Total Hip and Knee Joint Arthroplasty
March 14, 2012 updated by: Lawson Health Research Institute
The purpose of the study was to evaluate the effectiveness of balance exercises added to typical joint range of motion and muscle strengthening exercises on balance in patients following total hip or knee joint arthroplasty
Study Overview
Status
Completed
Detailed Description
Rehabilitation program following total hip and knee joint arthroplasty typically focus on joint range of motion and muscle strengthening exercises.
Although the balance ability of these patients tends to be reduced, leading to limitations in mobility and activities of daily living, clinicians often assume that strength and joint range of motion exercises will ultimately lead to improvement in balance, making the typical exercise programs appropriate.
However, the feasibility and effectiveness of introducing balance specific exercises during the post-operative period is unclear.
Study Type
Interventional
Enrollment (Actual)
82
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
London, Ontario, Canada, N6A 5C1
- School of Physical Therapy, University of Western Ontario
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
55 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients with primary unilateral total hip or knee joint arthroplasty.
- Patients who had been advised to weight bear as tolerated following surgery.
Exclusion Criteria:
- Patients who had been advised by their surgeon to remain non-weight bearing or partial weight bearing on the operated leg or unoperated leg.
- Patients with neurological conditions such as hemiplegia, peripheral neuropathy, Parkinsons disease, multiple sclerosis, or spinal cord compression that might affect balance.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Balance group
Typical plus balance exercises
|
Seven typical exercises, and three balance exercises, 10 times each, 3 times a day.
|
|
Other: Typical group
Typical exercises
|
Seven typical exercises, 10 times each, 3 times a day
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Berg balance scale
Time Frame: Day 0 and Week 5
|
Day 0 and Week 5
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Timed Up and go test
Time Frame: Day 0 and Week 5
|
Day 0 and Week 5
|
|
Western Ontario McMaster Universities Osteoarthritis Index
Time Frame: Day 0 and Week 5
|
Day 0 and Week 5
|
|
Activity-specific Balance Confidence Scale
Time Frame: Day 0 and Week 5
|
Day 0 and Week 5
|
|
Force platform
Time Frame: Week 5
|
Week 5
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: John Kramer, PhD, Western University, Canada
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2007
Primary Completion (Actual)
May 1, 2009
Study Completion (Actual)
April 1, 2010
Study Registration Dates
First Submitted
January 16, 2012
First Submitted That Met QC Criteria
March 14, 2012
First Posted (Estimate)
March 15, 2012
Study Record Updates
Last Update Posted (Estimate)
March 15, 2012
Last Update Submitted That Met QC Criteria
March 14, 2012
Last Verified
January 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R-06-461
- 12697E (Other Identifier: REB)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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