Back to resultsEffect of Physiotherapy After Total Knee Replacement
Primary Purpose
Knee Osteoarthritis
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
walking skill group
usual physiotherapy care
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis focused on measuring physiotherapy, functional outcome, activity level, self efficacy, task oriented exercises
Eligibility Criteria
Inclusion Criteria:
- Primary gonarthrosis
- Good written and oral understanding of Norwegian
- Good cognitive function
Exclusion Criteria:
- Severe gonarthrosis in the other knee or coxarthrosis
- Neurological disorders or rheumatoid arthritis
Sites / Locations
- Section of Nursing and Health Science, University of Oslo
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
walking skill group
usual physiotherapy care
Arm Description
weight-bearing 12 times, 70 minutes
partial weight-bearing, 12 times, 40 minutes
Outcomes
Primary Outcome Measures
6 minutes walk test
Secondary Outcome Measures
Self reported pain and activity level(KOOS)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00807716
Brief Title
Effect of Physiotherapy After Total Knee Replacement
Official Title
The Immediate and Long Term Effects of a Walking-skill Program Compared to Usual Physiotherapy Care in Patients Who Have Undergone Total Knee Arthroplasty (TKA): A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oslo
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Physiotherapy plays an important part in rehabilitation after total knee arthroplasty. Even if this is a common practice, few studies have been performed on this issue.
The prime aim of this study is to examine the effects of an ambulatory individualized task-oriented exercise program compared with current ambulatory physiotherapy(usual care)on activity performance and self efficacy beliefs in the time span 6 weeks to 3 months after total knee arthroplasty with a follow-up at twelve months.
HO:Task oriented physiotherapy has better effect than usual care on activity performance and self-efficacy beliefs in the time span 6 weeks to 3 months after total knee replacement.
Detailed Description
A randomized controlled trial was performed with an experiment group having task oriented exercises in only weight-bearing 12 times from 6 weeks to 12 weeks after the operation, while the control group had usual physiotherapy care during the same time span. The primary outcome was walking measured by the six minutes walk test. Other performed and self reported measures of physical functioning were performed, at baseline, six weeks after the operation, immediately after the intervention at 12-14 weeks and with a follow-up nine months after the intervention.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
physiotherapy, functional outcome, activity level, self efficacy, task oriented exercises
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
57 (Actual)
8. Arms, Groups, and Interventions
Arm Title
walking skill group
Arm Type
Experimental
Arm Description
weight-bearing 12 times, 70 minutes
Arm Title
usual physiotherapy care
Arm Type
Active Comparator
Arm Description
partial weight-bearing, 12 times, 40 minutes
Intervention Type
Other
Intervention Name(s)
walking skill group
Intervention Description
12 Individualized group training sessions with focus on functional exercises like walking and stair climbing including balance training under physiotherapy guidance, 12 times 70 minutes.
Intervention Type
Other
Intervention Name(s)
usual physiotherapy care
Intervention Description
physiotherapy, mostly in non-weight bearing, 12 times 40 minutes
Primary Outcome Measure Information:
Title
6 minutes walk test
Time Frame
preoperatively, baseline at 6 weeks, after the intervention at 3 months, 12onths
Secondary Outcome Measure Information:
Title
Self reported pain and activity level(KOOS)
Time Frame
preoperatively, 6 weeks, 3 months and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Primary gonarthrosis
Good written and oral understanding of Norwegian
Good cognitive function
Exclusion Criteria:
Severe gonarthrosis in the other knee or coxarthrosis
Neurological disorders or rheumatoid arthritis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Marit Mengshoel, PhD
Organizational Affiliation
professor
Official's Role
Study Director
Facility Information:
Facility Name
Section of Nursing and Health Science, University of Oslo
City
Oslo
ZIP/Postal Code
0318
Country
Norway
12. IPD Sharing Statement
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Effect of Physiotherapy After Total Knee Replacement
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