ClinicalTrials.gg
Status unknownNCT03368287Updated Dec 11, 2017

Activity Trackers for Monitoring During Rehabilitation After Total Knee Arthroplasty

An interventional study of Fitbit One, the activity tracker in Total Knee Arthroplasty, sponsored by Peking University People's Hospital. Status unknown. Open to participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-12-11.

Sponsored by Peking University People's Hospital · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Dec 2017), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
50 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Total Knee Arthroplasty

Keywords

  • Total Knee Arthroplasty
  • steps
  • rehabilitation
  • activity tracker
03

In context

Lead sponsor

Peking University People's Hospital is the lead sponsor of 604 studies on the registry; 242 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Ready to receive single-side TKA

Exclusion criteria

Exclusion Criteria:

  • contraindication of surgery
  • self-reported diseases that cause lower limb disability (for example, cerebrovascular disease especially stroke)
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • 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

Interventions

  • DeviceFitbit 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.

06

What researchers measure

Primary outcomes

  1. The change of steps of daily life

    steps

    Time frame: before operation and 6 weeks, 3 months, 6 months, 1 year after operation

Secondary outcomes

  1. 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.

    Time frame: before operation and 6 weeks, 3 months, 6 months, 1 year after operation

  2. 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.

    Time frame: before operation and 6 weeks, 3 months, 6 months, 1 year after operation

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 22520559 ↗
  • 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. PubMed 26464801 ↗
  • 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. PubMed 23992697 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 11, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03368287
Responsible party
Lin Jianhao (The clinical professor of arthritis clinic and research center, Peking University People's Hospital) — Principal investigator
First posted
Dec 11, 2017
Start date
Jan 1, 2018 (estimated)
Primary completion
Jan 30, 2019 (estimated)
Completion
Jan 31, 2019 (estimated)
Last update
Dec 11, 2017

Study contacts

Zhiwei Zhou
Contact
zzwwwdz@sina.com
+8613521817377
Jianhao Lin, MD
principal investigator · arthritic clinic and research center

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion