Postoperative Rehabilitation After Knee Arthroplasty: Anti-Gravity Treadmill

NCT03904030 | Completed

• 1 other identifier: OrtonOH
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rehabilitation

Keywords

knee arthroplasty; rehabilitation; anti-gravity treadmill; Randomized study

Outcome Measures

Primary Outcomes (3)

• Walking ability

  6 minutes walking test will be used

  12 months after operation

• 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

• 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

Study Arms (2)

Anti-Gravity Treadmill rehabilitation

EXPERIMENTAL

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.

Other: Rehabilitation with or without Anti-Gravity Treadmill

Traditional rehabilitation

ACTIVE COMPARATOR

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

Other: Rehabilitation with or without Anti-Gravity Treadmill

Interventions

Rehabilitation with or without Anti-Gravity Treadmill 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.

Anti-Gravity Treadmill rehabilitation; Traditional rehabilitation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• primary knee arthroplasty patients with grade III-V changes

You may not qualify if:

• earlier osteotomy to the operated knee
• rheumatoid arthritis

Sponsors & Collaborators

• Orton Orthopaedic Hospital: lead

Study Sites (1)

Orton Ltd

Helsinki, 00280, Finland

Location

Related Publications (14)

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• 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.

  PMID: 27327921 BACKGROUND

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  PMID: 10223000 BACKGROUND

• 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.

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• 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.

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  PMID: 18645984 BACKGROUND

• 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.

  PMID: 20510971 BACKGROUND

• 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.

  PMID: 39932768 DERIVED

MeSH Terms

Interventions

Rehabilitation

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Heikki Hurri

  Orton Ltd

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Director

Model Details: Anti-gravity treadmill rehabilitation and traditional rehabilitation

Study Record Dates

• First Submitted: April 1, 2019
• First Posted: April 4, 2019
• Study Start: January 1, 2019
• Primary Completion: July 31, 2022
• Study Completion: July 31, 2022
• Last Updated: September 22, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)