Activity Trackers for Monitoring During Rehabilitation After Total Knee Arthroplasty

December 5, 2017 updated by: Lin Jianhao, Peking University People's Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change of steps of daily life
Time Frame: before operation and 6 weeks, 3 months, 6 months, 1 year after operation
steps
before operation and 6 weeks, 3 months, 6 months, 1 year after operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
before operation and 6 weeks, 3 months, 6 months, 1 year after operation
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.
before operation and 6 weeks, 3 months, 6 months, 1 year after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University People's Hospital

Investigators

  • Principal Investigator: Jianhao Lin, MD, arthritic clinic and research center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2018

Primary Completion (Anticipated)

January 30, 2019

Study Completion (Anticipated)

January 31, 2019

Study Registration Dates

First Submitted

November 25, 2017

First Submitted That Met QC Criteria

December 5, 2017

First Posted (Actual)

December 11, 2017

Study Record Updates

Last Update Posted (Actual)

December 11, 2017

Last Update Submitted That Met QC Criteria

December 5, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PUPH20170958

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Total Knee Arthroplasty

Clinical Trials on Fitbit One, the activity tracker

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kosovo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe