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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03368287
Other study ID # PUPH20170958
Secondary ID
Status Not yet recruiting
Phase N/A
First received November 25, 2017
Last updated December 5, 2017
Start date January 1, 2018
Est. completion date January 31, 2019

Study information

Verified date December 2017
Source Peking University People's Hospital
Contact Zhiwei Zhou
Phone +8613521817377
Email zzwwwdz@sina.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date January 31, 2019
Est. primary completion date January 30, 2019
Accepts healthy volunteers No
Gender All
Age group 50 Years to 80 Years
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Peking University People's Hospital

References & Publications (3)

Cook DJ, Thompson JE, Prinsen SK, Dearani JA, Deschamps C. Functional recovery in the elderly after major surgery: assessment of mobility recovery using wireless technology. Ann Thorac Surg. 2013 Sep;96(3):1057-61. doi: 10.1016/j.athoracsur.2013.05.092. — View Citation

Kooiman TJ, Dontje ML, Sprenger SR, Krijnen WP, van der Schans CP, de Groot M. Reliability and validity of ten consumer activity trackers. BMC Sports Sci Med Rehabil. 2015 Oct 12;7:24. doi: 10.1186/s13102-015-0018-5. eCollection 2015. — View Citation

Patel S, Park H, Bonato P, Chan L, Rodgers M. A review of wearable sensors and systems with application in rehabilitation. J Neuroeng Rehabil. 2012 Apr 20;9:21. doi: 10.1186/1743-0003-9-21. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary The change of steps of daily life steps before operation and 6 weeks, 3 months, 6 months, 1 year after operation
Secondary The change of pain score 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. before operation and 6 weeks, 3 months, 6 months, 1 year after operation
Secondary The change of knee joint symptoms. 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. before operation and 6 weeks, 3 months, 6 months, 1 year after operation
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