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Activity Trackers for Monitoring During Rehabilitation After Total Knee Arthroplasty

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ClinicalTrials.gov Identifier: NCT03368287
Recruitment Status : Not yet recruiting
First Posted : December 11, 2017
Last Update Posted : December 11, 2017
Sponsor:
Information provided by (Responsible Party):
Lin Jianhao, Peking University People's Hospital

Brief Summary:
This study aims to estimated the change of the steps of daily life of osteoarthritis patients before and in 6 weeks, 3 months, 6 months, 1 year after the total knee arthroplasty (TKA) through a kind of activity tracker: Fitbit ONE.

Condition or disease Intervention/treatment Phase
Total Knee Arthroplasty Device: Fitbit One, the activity tracker Not Applicable

Detailed Description:
A total of 100 participants who will receive total knee arthroplasty will be recruited in this study. Fitbit ONE, the activity tracker, will be used for all of them to monitor the daily steps during the rehabilitation, to be exact, before and at 6 weeks, 3 months, 6 months, 1 year after TKA. Moreover, pain score, self reported questionnaire will also be estimated at those time points.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Activity Trackers for Monitoring During Rehabilitation After Total Knee Arthroplasty
Estimated Study Start Date : January 1, 2018
Estimated Primary Completion Date : January 30, 2019
Estimated Study Completion Date : January 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: activity tracker
In this study, Fitbit One, the activity tracker, will be used for every participants to evaluate the daily steps before and after surgery for one year
Device: Fitbit One, the activity tracker
Activity tracker, Fitbit One, will be used for a week to evaluate the steps of daily life before the surgery and at the time of follow up.




Primary Outcome Measures :
  1. The change of steps of daily life [ Time Frame: before operation and 6 weeks, 3 months, 6 months, 1 year after operation ]
    steps


Secondary Outcome Measures :
  1. The change of pain score [ Time Frame: before operation and 6 weeks, 3 months, 6 months, 1 year after operation ]
    Visual Analogue Scale of pain is a scale to estimate pain, and its score ranges from 0 to 10. The higher the score is, the more severe pain the patient is feeling.

  2. The change of knee joint symptoms. [ Time Frame: before operation and 6 weeks, 3 months, 6 months, 1 year after operation ]
    The Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC),and its score ranges from 0 to 96. The higher the score is, the more severe symptoms the patient is feeling.



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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ready to receive single-side TKA

Exclusion Criteria:

  • contraindication of surgery
  • self-reported diseases that cause lower limb disability (for example, cerebrovascular disease especially stroke)

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): NCT03368287


Contacts
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Contact: Zhiwei Zhou +8613521817377 zzwwwdz@sina.com

Sponsors and Collaborators
Peking University People's Hospital
Investigators
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Principal Investigator: Jianhao Lin, MD arthritic clinic and research center

Publications:
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Responsible Party: Lin Jianhao, The clinical professor of arthritis clinic and research center, Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT03368287     History of Changes
Other Study ID Numbers: PUPH20170958
First Posted: December 11, 2017    Key Record Dates
Last Update Posted: December 11, 2017
Last Verified: December 2017
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 Lin Jianhao, Peking University People's Hospital:
Total Knee Arthroplasty
steps
rehabilitation
activity tracker