Postoperative Rehabilitation After Knee Arthroplasty: Anti-Gravity Treadmill

Rehabilitation Clinical Trial

Official title:

Postoperative Rehabilitation After Knee Arthroplasty, With or Without Anti-Gravity Treadmill

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03904030
• Other study ID #: OrtonOH
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: July 31, 2022

Study information

• Verified date: September 2022
• Source: Orton Orthopaedic Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: July 31, 2022
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• primary knee arthroplasty patients with grade III-V changes

Exclusion Criteria:

• earlier osteotomy to the operated knee

• rheumatoid arthritis

Related Conditions & MeSH terms

• Rehabilitation

Intervention

Other:
• Rehabilitation with or without Anti-Gravity Treadmill
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.

Locations

Country	Name	City	State
Finland	Orton Ltd	Helsinki

Sponsors (1)

Lead Sponsor	Collaborator
Orton Orthopaedic Hospital

Country where clinical trial is conducted

Finland, 

References & Publications (13)

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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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Freynhagen R, Baron R, Gockel U, Tölle 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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Valtonen A, Pöyhönen T, Sipilä 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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Walking ability	6 minutes walking test will be used	12 months after operation
Primary	Health-related quality of life	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	12 months
Primary	Perceived pain	Visual analogue scale, (0 to 100, where 0 means no pain at all and 100 means the worst possible pain)	12 months after operation