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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

Tracking Information
First Submitted Date  ICMJE April 1, 2019
First Posted Date  ICMJE April 4, 2019
Last Update Posted Date April 9, 2019
Actual Study Start Date  ICMJE January 1, 2019
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 5, 2019)
  • Walking ability [ Time Frame: 12 months after operation ]
    6 minutes walking test will be used
  • 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
  • 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)
Original Primary Outcome Measures  ICMJE
 (submitted: April 3, 2019)
  • Walking ability [ Time Frame: 12 months after operation ]
    We will use 6 minutes walking test
  • Health-related quality of life [ Time Frame: 12 months ]
    We will use RAND-36 (The RAND Health-Related Quality of Life Inventory, 36-Item Health Survey) questionnaire
  • Perceived pain [ Time Frame: 12 months after operation ]
    Visual analogue scale
Change History Complete list of historical versions of study NCT03904030 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Postoperative Rehabilitation After Knee Arthroplasty: Anti-Gravity Treadmill
Official Title  ICMJE Postoperative Rehabilitation After Knee Arthroplasty, With or Without Anti-Gravity Treadmill
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.

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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Anti-gravity treadmill rehabilitation and traditional rehabilitation
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Rehabilitation
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Other: Rehabilitation with or without Anti-Gravity Treadmill
  • Active Comparator: Traditional rehabilitation
    Traditional exercises with instructions are given to the patients (n=27) (as a control group).
    Intervention: Other: Rehabilitation with or without Anti-Gravity Treadmill
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 3, 2019)
54
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • primary knee arthroplasty patients with grade III-V changes

Exclusion Criteria:

  • earlier osteotomy to the operated knee
  • rheumatoid arthritis
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Leena Ristolainen +358 40 6312255 leena.ristolainen@orton.fi
Contact: Heikki Hurri +358 50 5922600 heikki.hurri@orton.fi
Listed Location Countries  ICMJE Finland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03904030
Other Study ID Numbers  ICMJE OrtonOH
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Leena Ristolainen, Orton Orthopaedic Hospital
Study Sponsor  ICMJE Orton Orthopaedic Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Heikki Hurri Orton Ltd
PRS Account Orton Orthopaedic Hospital
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP