- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03904030
Postoperative Rehabilitation After Knee Arthroplasty: Anti-Gravity Treadmill
Postoperative Rehabilitation After Knee Arthroplasty, With or Without Anti-Gravity Treadmill
The aim of this study is to clarify the effectiveness and the usefulness of the anti-gravity treadmill in postoperative rehabilitation after knee arthroplasty. The investigators will compare anti-gravity treadmill rehabilitation and the traditional postoperative rehabilitation with instructions.
The investigators will assume that anti-gravity treadmill exercise after hospitalization will lead to the faster rehabilitation, better walking quality and balance management compared to traditional rehabilitation methods with instructions, where patient themselves do the exercises at home. Additionally, the investigators will assume that quality of life and physical activity will be more increased in the anti-gravity group than in the traditional rehabilitation.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The aim of this study is to clarify the effectiveness and the usefulness of the anti-gravity treadmill in postoperative rehabilitation after knee arthroplasty. This issue is especially relevant because the number of knee arthroplasty patients is increasing. The rehabilitation of knee arthroplasty patients has also appeared to be more challenging than in the case of hip arthroplasty.
The investigators will compare anti-gravity treadmill rehabilitation and the traditional postoperative rehabilitation with instructions. The investigators will recruit the patients either in the anti-gravity group (n=27) or in the traditional rehabilitation (n=27) (randomized study design).
The investigators will assume that anti-gravity treadmill exercise after hospitalization will lead to the faster rehabilitation, better walking quality and balance management compared to the traditional rehabilitation.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Helsinki, Finland, 00280
- Orton Ltd
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- primary knee arthroplasty patients with grade III-V changes
Exclusion Criteria:
- earlier osteotomy to the operated knee
- rheumatoid arthritis
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Anti-Gravity Treadmill rehabilitation
Patients in the intervention group are participating to the Alter G exercises (n=27).
The groups are randomized, so after patients have signed consent, an envelop will be opened and there can be seen in which groups patients will participate.
|
The study will include patients with grade III-IV primary knee osteoarthritis.
The investigators will take 27 patients to the both groups.
The investigators will look after more specifically the anti-gravity treadmill rehabilitation and traditional rehabilitation after arthroplasty.
Follow-up is one year.
Functional tests will be made and questionnaires will be given to the patients before operation and after operation.
After 6 to 8 weeks, 4 months and 12 months of operation questionnaires will be fil up again.
After six month the investigators will send a questionnaire and there will be asked possible rehabilitation sessions, use of drugs and possible complications after knee arthroplasty.
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ACTIVE_COMPARATOR: Traditional rehabilitation
Traditional exercises with instructions are given to the patients (n=27) (as a control group).
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The study will include patients with grade III-IV primary knee osteoarthritis.
The investigators will take 27 patients to the both groups.
The investigators will look after more specifically the anti-gravity treadmill rehabilitation and traditional rehabilitation after arthroplasty.
Follow-up is one year.
Functional tests will be made and questionnaires will be given to the patients before operation and after operation.
After 6 to 8 weeks, 4 months and 12 months of operation questionnaires will be fil up again.
After six month the investigators will send a questionnaire and there will be asked possible rehabilitation sessions, use of drugs and possible complications after knee arthroplasty.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Walking ability
Time Frame: 12 months after operation
|
6 minutes walking test will be used
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12 months after operation
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Health-related quality of life
Time Frame: 12 months
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The RAND Health-Related Quality of Life Inventory, RAND 36-Item, will be used, RAND-36 includes: Physical functioning,10 questions; Role functioning/physical, 4 questions; Role functioning/emotional, 3 questions; Energy/fatique, 4 questions, Emotional well-being, 5 questions; Social functioning, 2 questions; Pain, 2 questions; General health, 5 questions; Health change, 1 question.
All: 36 questions.
Scale: 0 - 100
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12 months
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Perceived pain
Time Frame: 12 months after operation
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Visual analogue scale, (0 to 100, where 0 means no pain at all and 100 means the worst possible pain)
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12 months after operation
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Heikki Hurri, Orton Ltd
Publications and helpful links
General Publications
- Bellamy N, Buchanan WW, Goldsmith CH, Campbell J, Stitt LW. Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol. 1988 Dec;15(12):1833-40.
- Freynhagen R, Baron R, Gockel U, Tolle TR. painDETECT: a new screening questionnaire to identify neuropathic components in patients with back pain. Curr Med Res Opin. 2006 Oct;22(10):1911-20. doi: 10.1185/030079906X132488.
- Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991 Feb;39(2):142-8. doi: 10.1111/j.1532-5415.1991.tb01616.x.
- BECK AT, WARD CH, MENDELSON M, MOCK J, ERBAUGH J. An inventory for measuring depression. Arch Gen Psychiatry. 1961 Jun;4:561-71. doi: 10.1001/archpsyc.1961.01710120031004. No abstract available.
- Dawson J, Fitzpatrick R, Murray D, Carr A. Questionnaire on the perceptions of patients about total knee replacement. J Bone Joint Surg Br. 1998 Jan;80(1):63-9. doi: 10.1302/0301-620x.80b1.7859.
- Bugbee WD, Pulido PA, Goldberg T, D'Lima DD. Use of an Anti-Gravity Treadmill for Early Postoperative Rehabilitation After Total Knee Replacement: A Pilot Study to Determine Safety and Feasibility. Am J Orthop (Belle Mead NJ). 2016 May-Jun;45(4):E167-73.
- Cheatham SW, Mokha M, Lee M. Postoperative Rehabilitation After Hip Resurfacing: A Systematic Review. J Sport Rehabil. 2016 May;25(2):181-9. doi: 10.1123/jsr.2014-0270. Epub 2015 Jan 22.
- Gaudry E, Vagg P, Spielberger CD. Validation of the State-Trait Distinction in Anxiety Research. Multivariate Behav Res. 1975 Jul 1;10(3):331-41. doi: 10.1207/s15327906mbr1003_6.
- Guyatt GH, Sullivan MJ, Thompson PJ, Fallen EL, Pugsley SO, Taylor DW, Berman LB. The 6-minute walk: a new measure of exercise capacity in patients with chronic heart failure. Can Med Assoc J. 1985 Apr 15;132(8):919-23.
- Konlian C. Aquatic therapy: making a wave in the treatment of low back injuries. Orthop Nurs. 1999 Jan-Feb;18(1):11-8; quiz 19-20. doi: 10.1016/s1361-3111(99)80068-5.
- Patil S, Steklov N, Bugbee WD, Goldberg T, Colwell CW Jr, D'Lima DD. Anti-gravity treadmills are effective in reducing knee forces. J Orthop Res. 2013 May;31(5):672-9. doi: 10.1002/jor.22272. Epub 2012 Dec 13.
- Soininen JV, Paavolainen PO, Gronblad MA, Kaapa EH. Validation study of a Finnish version of the Western Ontario and McMasters University osteoarthritis index. Hip Int. 2008 Apr-Jun;18(2):108-11. doi: 10.1177/112070000801800207.
- Valtonen A, Poyhonen T, Sipila S, Heinonen A. Effects of aquatic resistance training on mobility limitation and lower-limb impairments after knee replacement. Arch Phys Med Rehabil. 2010 Jun;91(6):833-9. doi: 10.1016/j.apmr.2010.03.002.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- OrtonOH
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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