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A Quantitative Assessment of Early Mobility in Total Knee Replacement Patients Using Smart Activity Tracker

A Quantitative Assessment of Early Mobility in Total Knee Replacement Patients Using Smart Activity Tracker

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05076539
Acronym
Geospatial
Enrollment
50
Registered
2021-10-13
Start date
2018-06-11
Completion date
2023-01-30
Last updated
2022-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthritis

Brief summary

This study aims to evaluate the patients' mobility and quality of life prior to their total knee replacement surgery and their progress pre-operatively and 6 months post-operatively using the smart activity tracker. We hypothesize that mobility limitation presents a strong correlation with reduced quality of life.

Detailed description

The present study is to determine the effect of TKA based on their mobility and QOL pre and post surgery. The GPS and accelerometry-based tracker will be able to provide quantitative-based outcomes to indicate the physical activity of patients after TKR remains at or above pre-surgical levels. A total of 50 participants are to be enrolled in this cross-sectional study. Patients who will be required to undergo unilateral total knee replacement will be recruited when fulfilling the respective inclusion and exclusion criteria. The patients will undergo the standard consultations and rehabilitation pre - and post operative care, no changes to the treatment itself will be made. After recruitment and counseling by the surgeon for TKR, the patients will have pre-operative baseline clinical scores taken prior to surgery. They will subsequently have their TKR surgery. Post-operatively, they will be followed up prospectively at the clinics as well as Orthopaedics Diagnostic Centre. Their outcome will be evaluated using validated scoring system, Oxford Knee Score, SF-36, Knee Society Clinical Rating System, satisfaction questionnaire, as well as be provided with a GPS-activity tracker. 50 patients will be issued a Garmin GPS-activity tracker where they will be required to wear for 24 hours for 1 week, prior to each timepoint (pre-operatively and 6 months post surgery). The de-identified raw data gathered from the Garmin tracker will be collected by Curtin University for their analysis. The patients will undergo the standard consultations and rehabilitation pre - and postoperative care, no changes to the treatment itself will be made. Standard consultations/review by orthopaedic specialist * Pre-surgery * 6 months post surgery Standard Orthopaedic Diagnostic Center (ODC) data collection timepoints * Pre-surgrey * 6 months Standard rehabilitation care * Upon discharge * 2 - 3 weeks post discharge in outpatient services (OPS) On top of the standard consultations and rehabilitation pre - and postoperative care, the patients will be monitored on their normal lifestyle at home using a tracker worn on their wrists for 1 week, pre-operatively and 6 months post surgery.

Interventions

OTHERGarmin GPS activity tracker

50 patients will be issued a Garmin GPS-activity tracker where they will be required to wear for 24 hours for 1 week, prior to each timepoint (pre-operatively and 6 months post surgery).

Sponsors

Curtin University
CollaboratorOTHER
Singapore General Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Patients who are referred by the Orthopaedic surgeon and are diagnosed with Knee Osteoarthritis, and consented to unilateral total knee replacement. * Able to ambulate with or without walking aid. * Ability to provide informed consent.

Exclusion criteria

* Patients who have severe bilateral Knee Osteoarthritis, affecting their ability to walk and only one will be operated on. * Patients with pre-existing cognitive issues, such as dementia. * Patients planning for another surgery within 6 months after their TKR. * Patients with existing co-morbidities that limit their walking ability, such as severe respiratory distress syndromes.

Design outcomes

Primary

MeasureTime frameDescription
Knee Society Clinical Rating systempre-surgeryMeasuring knee range of motion, knee extension lag, knee alignment in standing using the knee society clinical rating system (KSS Scores)
Oxford Kneepre-surgeryUsing the Oxford Knee questionnaire to get the oxford knee score
SF 36 Health surveypre-surgerySF36 questionnaires to get SF-36 scores
Expectation met for surgerypre-surgeryPatient satisfaction form
Overall result of surgerypre-surgerySubject's summary and outcomes form; data collected from Orthopaedic diagnostis center (ODC)
Length of stayup to 6 months post surgerythe number of nights spend in the hospital from the day of surgery
Premorbid historyup to 6 months post surgeryPatients reported ambulation status before surgery, including the use of walking aids and assistance level required
Early ambulation rateup to 6 months post surgeryPercentage of patients who start walking postoperative day (POD) 1
Knee range-of-motionup to 6 months post surgerymeasure knee ROM
Ability to perform a straight leg raiseup to 6 months post surgeryIf patient is able to lift their leg independently. Lag is measured by a goniometer measured by a goniometer
Type of walking aids usedup to 6 months post surgeryThe type of walking aids required, namely, walking frame, broad- and narrow-based quadstick, or walking stick (in descending order of base of support provided)
Discharge Destinationup to 6 months post surgeryWhere the patient will be going to after discharge from SGH
Data Collected from Garmin GPS-activity trackerPre-surgery for 1 week1. Latitude and longitudinal location coordinates to determine an individual's activity space 2. Distance travelled 3. Walking speed 4. Heart rate 5. Calories burned 6. Energy expenditure 7. Steps count 8. Physical activity

Countries

Singapore

Contacts

Primary ContactCelia Tan Ia Choo
celia.tan.i.c@singhealth.com.sg91721220
Backup ContactYeo Hwee Shan
yeo.hwee.shan@sgh.com.sg

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026