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NCT Number: NCT03904030

Postoperative Rehabilitation After Knee Arthroplasty: 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.

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Key information

Conditions

Rehabilitation

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Orton Ltd

Helsinki, 00280, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • primary knee arthroplasty patients with grade III-V changes

Exclusion criteria

  • earlier osteotomy to the operated knee
  • rheumatoid arthritis

Treatment and study plan

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.

Primary outcomes

  1. Walking ability

    Time frame: 12 months after operation

    6 minutes walking test will be used

  2. Health-related quality of life

    Time frame: 12 months

    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

  3. Perceived pain

    Time frame: 12 months after operation

    Visual analogue scale, (0 to 100, where 0 means no pain at all and 100 means the worst possible pain)

Sponsors and collaborators

Lead sponsor

Orton Orthopaedic Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Apr 4, 2019
Registry last updated
Sep 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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