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Effect of Physiotherapy After Total Knee Replacement

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vigdis Bruun-Olsen, University of Oslo
ClinicalTrials.gov Identifier:
NCT00807716
First received: December 11, 2008
Last updated: December 4, 2014
Last verified: December 2014
  Purpose

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.


Condition Intervention
Knee Osteoarthritis
Other: walking skill group
Other: usual physiotherapy care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by University of Oslo:

Primary Outcome Measures:
  • 6 minutes walk test [ Time Frame: preoperatively, baseline at 6 weeks, after the intervention at 3 months, 12onths ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Self reported pain and activity level(KOOS) [ Time Frame: preoperatively, 6 weeks, 3 months and 12 months ] [ Designated as safety issue: No ]

Enrollment: 57
Study Start Date: October 2008
Study Completion Date: December 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: walking skill group
weight-bearing 12 times, 70 minutes
Other: walking skill group
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.
Active Comparator: usual physiotherapy care
partial weight-bearing, 12 times, 40 minutes
Other: usual physiotherapy care
physiotherapy, mostly in non-weight bearing, 12 times 40 minutes

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.

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00807716

Locations
Norway
Section of Nursing and Health Science, University of Oslo
Oslo, Norway, 0318
Sponsors and Collaborators
University of Oslo
Investigators
Study Director: Anne Marit Mengshoel, PhD professor
  More Information

No publications provided

Responsible Party: Vigdis Bruun-Olsen, PHD student, University of Oslo
ClinicalTrials.gov Identifier: NCT00807716     History of Changes
Other Study ID Numbers: 2008/2436
Study First Received: December 11, 2008
Last Updated: December 4, 2014
Health Authority: Norway: Norwegian Social Science Data Services
Norway:National Committee for Medical and Health Research Ethics

Keywords provided by University of Oslo:
physiotherapy
functional outcome
activity level
self efficacy
task oriented exercises

ClinicalTrials.gov processed this record on March 03, 2015