Activity Trackers for Monitoring During Rehabilitation After Total Knee Arthroplasty

Total Knee Arthroplasty Clinical Trial

Official title:

Activity Trackers for Monitoring During Rehabilitation After Total Knee Arthroplasty

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03368287
• Other study ID #: PUPH20170958
• 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
• 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)

Related Conditions & MeSH terms

• Total Knee Arthroplasty

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