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Trial record 6 of 24 for:    13688369 [PUBMED-IDS]

Postoperative Rehabilitation After Knee Arthroplasty: Anti-Gravity Treadmill

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ClinicalTrials.gov Identifier: NCT03904030
Recruitment Status : Recruiting
First Posted : April 4, 2019
Last Update Posted : April 9, 2019
Sponsor:
Information provided by (Responsible Party):
Leena Ristolainen, Orton Orthopaedic Hospital

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.


Condition or disease Intervention/treatment Phase
Rehabilitation Other: Rehabilitation with or without Anti-Gravity Treadmill Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Anti-gravity treadmill rehabilitation and traditional rehabilitation
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Postoperative Rehabilitation After Knee Arthroplasty, With or Without Anti-Gravity Treadmill
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


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.
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.

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




Primary Outcome Measures :
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • primary knee arthroplasty patients with grade III-V changes

Exclusion Criteria:

  • earlier osteotomy to the operated knee
  • rheumatoid arthritis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03904030


Contacts
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Contact: Leena Ristolainen +358 40 6312255 leena.ristolainen@orton.fi
Contact: Heikki Hurri +358 50 5922600 heikki.hurri@orton.fi

Locations
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Finland
Orton Ltd Recruiting
Helsinki, Finland, 00280
Sponsors and Collaborators
Orton Orthopaedic Hospital
Investigators
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Study Director: Heikki Hurri Orton Ltd

Publications:

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Responsible Party: Leena Ristolainen, Research and Education Manager, Orton Orthopaedic Hospital
ClinicalTrials.gov Identifier: NCT03904030     History of Changes
Other Study ID Numbers: OrtonOH
First Posted: April 4, 2019    Key Record Dates
Last Update Posted: April 9, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Leena Ristolainen, Orton Orthopaedic Hospital:
knee arthroplasty
rehabilitation
anti-gravity treadmill
Randomized study