Postoperative Rehabilitation After Knee Arthroplasty: Anti-Gravity Treadmill

Sponsor
Orton Orthopaedic Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT03904030
Collaborator
(none)
54
1
2
84
0.6

Study Details

Study Description

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
  • Other: Rehabilitation with or without Anti-Gravity Treadmill
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
54 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Anti-gravity treadmill rehabilitation and traditional rehabilitationAnti-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 :
Jan 1, 2019
Anticipated Primary Completion Date :
Jun 30, 2022
Anticipated Study Completion Date :
Dec 31, 2025

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Walking ability [12 months after operation]

    6 minutes walking test will be used

  2. Health-related quality of life [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 [12 months after operation]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • primary knee arthroplasty patients with grade III-V changes
Exclusion Criteria:
  • earlier osteotomy to the operated knee

  • rheumatoid arthritis

Contacts and Locations

Locations

Site City State Country Postal Code
1 Orton Ltd Helsinki Finland 00280

Sponsors and Collaborators

  • Orton Orthopaedic Hospital

Investigators

  • Study Director: Heikki Hurri, Orton Ltd

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Leena Ristolainen, Research and Education Manager, Orton Orthopaedic Hospital
ClinicalTrials.gov Identifier:
NCT03904030
Other Study ID Numbers:
  • OrtonOH
First Posted:
Apr 4, 2019
Last Update Posted:
Sep 9, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Leena Ristolainen, Research and Education Manager, Orton Orthopaedic Hospital

Study Results

No Results Posted as of Sep 9, 2021