Postoperative Rehabilitation After Knee Arthroplasty: Anti-Gravity Treadmill

NCT ID: NCT03904030

Last Updated: 2022-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2022-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Rehabilitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Anti-gravity treadmill rehabilitation and traditional rehabilitation
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Rehabilitation with or without Anti-Gravity Treadmill

Intervention Type OTHER

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.

Traditional rehabilitation

Traditional exercises with instructions are given to the patients (n=27) (as a control group).

Group Type ACTIVE_COMPARATOR

Rehabilitation with or without Anti-Gravity Treadmill

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* primary knee arthroplasty patients with grade III-V changes

Exclusion Criteria

* earlier osteotomy to the operated knee
* rheumatoid arthritis
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Orton Orthopaedic Hospital

OTHER

Sponsor Role lead

Responsible Party

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Leena Ristolainen

Research Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Heikki Hurri

Role: STUDY_DIRECTOR

Orton Ltd

Locations

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Orton Ltd

Helsinki, , Finland

Site Status

Countries

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Finland

References

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Reference Type BACKGROUND
PMID: 3068365 (View on PubMed)

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.

Reference Type BACKGROUND
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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.

Reference Type BACKGROUND
PMID: 25611202 (View on PubMed)

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.

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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.

Reference Type BACKGROUND
PMID: 3978515 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10223000 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23239580 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1991946 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18645984 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20510971 (View on PubMed)

Jaaskelainen E, Manninen M, Hurri H, Rantasalo M, Zhou Y, Kautiainen H, Ristolainen L. Effectiveness of Anti-Gravity Treadmill Exercise After Total Knee Arthroplasty: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Feb 11;14:e59935. doi: 10.2196/59935.

Reference Type DERIVED
PMID: 39932768 (View on PubMed)

Other Identifiers

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OrtonOH

Identifier Type: -

Identifier Source: org_study_id

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