Activity Trackers for Monitoring During Rehabilitation After Total Knee Arthroplasty

Not Applicable

• Conditions: Total Knee Arthroplasty
• Interventions: Device: Fitbit One, the activity tracker

• Registration Number: NCT03368287
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2017-11-25
• Status Verified: 2017-12
• Study First Submitted QC: 2017-12-05
• Last Update Submitted: 2017-12-05
• Study First Posted: 2017-12-11
• Last Update Posted: 2017-12-11
• Study Start: 2018-01-01
• Primary Completion: 2019-01-30
• Study Completion: 2019-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
activity tracker	Fitbit One, the 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

Primary Outcome Measures

Name	Time	Method
The change of steps of daily life	before operation and 6 weeks, 3 months, 6 months, 1 year after operation	steps

Secondary Outcome Measures

Name	Time	Method
The change of pain score	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.
The change of knee joint symptoms.	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.