Knee OsteoarthritisNCT00807716
Effect of Physiotherapy After Total Knee Replacement
A study testing walking skill group and usual physiotherapy care in people with Knee Osteoarthritis, run by University of Oslo at 1 site in Norway.
Trial 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… Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- walking skill group and usual physiotherapy care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteNorway
- Study dates
- Oct 2008to Dec 2011
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary gonarthrosis
- Good written and oral understanding of Norwegian
- Good cognitive function
Who cannot join
- Severe gonarthrosis in the other knee or coxarthrosis
- Neurological disorders or rheumatoid arthritis
Trial locations and contacts
1 site in 1 country.
Norway1 site
Section of Nursing and Health Science, University of Oslo
Oslo, 0318
About this study
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
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.
Read the 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.
- Conditions
- Knee Osteoarthritis
- Being tested
- walking skill group, usual physiotherapy care
- Keywords
- physiotherapy, functional outcome, activity level, self efficacy, task oriented exercises
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
walking skill groupOther
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.
usual physiotherapy careOther
physiotherapy, mostly in non-weight bearing, 12 times 40 minutes
| Study group | Role | What they receive |
|---|---|---|
| walking skill group | Experimental | weight-bearing 12 times, 70 minutes Receives: Other: walking skill group |
| usual physiotherapy care | Active comparator | partial weight-bearing, 12 times, 40 minutes Receives: Other: usual physiotherapy care |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 minutes walk test
Measured: preoperatively, baseline at 6 weeks, after the intervention at 3 months, 12onths
Secondary outcomes (1)
Self reported pain and activity level(KOOS)
Measured: preoperatively, 6 weeks, 3 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2008 (estimated)
- Study startOct 2008
- Primary completionDec 2010
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies 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
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oslo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vigdis Bruun-Olsen, University of Oslo
- Investigators
- Anne Marit Mengshoel, PhD, Study director, professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00807716
- Sponsor's protocol ID
- 2008/2436
- Status last verified
- Dec 2014
- First submitted
- 11 Dec 2008
- Last updated
- 5 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00807716
- Acronym / sponsor ID
- 2008/2436
- Conditions
- Knee Osteoarthritis
- Keywords
- physiotherapy, functional outcome, activity level, self efficacy, task oriented exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University of OsloUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 12 Dec 2008 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| walking skill group | Experimental | Other: walking skill groupweight-bearing 12 times, 70 minutes |
| usual physiotherapy care | Active comparator | Other: usual physiotherapy carepartial weight-bearing, 12 times, 40 minutes |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Primary gonarthrosis
- Good written and oral understanding of Norwegian
- Good cognitive function
Key exclusion criteria (2 listed)
- Severe gonarthrosis in the other knee or coxarthrosis
- Neurological disorders or rheumatoid arthritis
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 |
|---|---|---|
| walking skill group12 Individualized group training sessions with focus on functional exercises like walking and stair climbing including balance training under physiotherapy guidance, 12 times 70 minutes. | Other | walking skill group |
| usual physiotherapy carephysiotherapy, mostly in non-weight bearing, 12 times 40 minutes | Other | usual physiotherapy care |
Primary outcome
6 minutes walk test
Time frame: preoperatively, baseline at 6 weeks, after the intervention at 3 months, 12onths
1 secondary outcome
Self reported pain and activity level(KOOS)
Time frame: preoperatively, 6 weeks, 3 months and 12 months
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 5 Dec 2014.
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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.
Anne Marit Mengshoel, PhD study director
professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing walking skill group and usual physiotherapy care in people with Knee Osteoarthritis, run by University of Oslo at 1 site in Norway.
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 2 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 5 Dec 2014. 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 Norway. 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?
6 minutes walk test (time frame: preoperatively, baseline at 6 weeks, after the intervention at 3 months, 12onths). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Dec 2014.