Total Knee Arthroplasty RecoveryNCT07875725
Wearable Knee-Assisted Rehabilitation for Range of Motion and Muscle Strength After Total Knee Arthroplasty
A study testing ReBK Wearable Telerehabilitation System and Standard Home-Based Rehabilitation in people with Total Knee Arthroplasty Recovery and Knee Osteoarthritis, run by University of Chile at 3 sites in Chile.
Trial summary
This randomized controlled trial evaluates a wearable electrogoniometry-based telerehabilitation system designed to support recovery after total knee arthroplasty. Participants follow the same home-based rehabilitation exercise program and are randomly assigned to an intervention or control group. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Total Knee Arthroplasty Recovery, Knee Osteoarthritis
- What is being tested?
- ReBK Wearable Telerehabilitation System and Standard Home-Based Rehabilitation
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 3 sitesChile
- Study dates
- 21 Sep 2026to 30 Sep 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults older than 60 years scheduled for primary total knee arthroplasty for knee osteoarthritis.
- Ability to attend postoperative follow-up assessments.
Who cannot join
- Revision arthroplasty.
- Use of constrained implants.
- Cognitive impairment preventing adherence to rehabilitation instructions.
- Inability to participate in follow-up assessments.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Chile3 sites
Hospital Dr. Franco Ravera Zunino
Rancagua, Región del Libertador General Bernardo O’Higgins, rancagua
Nicolas Jabes, MD, 997595606, dr.nicolas.jabes@gmail.com
Hospital Clinico Universidad de Chile
Santiago, Santiago Metropolitan, santiago
Macarena A Barahona, PT, +56999054293, maca.b.v@gmail.com
Hachi Manzur, MD
Hospital Las Higueras de Talcahuano
Talcahuano
Francisco Urrizola, +56992997832, urrizola@gmail.com
Nelson Morales, +56974081638, dr.nmorales.rodilla@gmail.com
About this study
Official title: Wearable Knee-Assisted Rehabilitation to Improve Range of Motion and Muscle Strength During Early Recovery After Total Knee Arthroplasty: A Randomized Controlled Trial
This randomized controlled trial evaluates a wearable electrogoniometry-based telerehabilitation system designed to support recovery after total knee arthroplasty. Participants follow the same home-based rehabilitation exercise program and are randomly assigned to an intervention or control group. Participants in the intervention group additionally use a wearable knee device connected to a digital application that provides guidance and real-time feedback during exercise and allows remote monitoring of rehabilitation. Knee range of motion, functional performance, and isometric quadriceps strength are assessed before surgery and during the 12-week postoperative follow-up. The study compares recovery between patients using the technology-assisted rehabilitation system and those following the conventional home-based rehabilitation program.
Read the detailed description
Participants are randomly assigned to either the control group or the intervention group. Both groups follow the same standardized home-based rehabilitation exercise program after total knee arthroplasty. Participants assigned to the intervention group additionally use the wearable electrogoniometry-based telerehabilitation system during their rehabilitation exercises.
Clinical and functional outcomes are assessed throughout the 12-week postoperative follow-up. Assessments include knee range of motion, functional performance, and isometric quadriceps strength. Isometric quadriceps strength is measured using a Tindeq dynamometer and recorded in kilograms at baseline, postoperative week 1, week 4, week 8, and approximately week 12. Participants also complete self-reported assessments, and participants in the intervention group complete an additional questionnaire evaluating usability and their experience with the technology-assisted rehabilitation system.
- Being tested
- ReBK Wearable Telerehabilitation System, Standard Home-Based Rehabilitation
- Keywords
- Telerehabilitation, Total Knee Arthroplasty, Wearable Technology, Electrogoniometry, Range of Motion, Quadriceps Strength, Home-Based Rehabilitation
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReBK Wearable Telerehabilitation SystemDevice
Participants use the ReBK wearable telerehabilitation system during prescribed home-based rehabilitation exercises. The system consists of a sensorized knee device connected to a digital application that provides guided exercise, real-time feedback based on knee movement, and remote monitoring of rehabilitation progress.
Standard Home-Based RehabilitationBehavioural
articipants follow the standard postoperative rehabilitation program after total knee arthroplasty and perform the prescribed home-based exercises without using the ReBK wearable telerehabilitation system.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Participants receive the standard postoperative rehabilitation program after total knee arthroplasty and perform the prescribed home-based exercises without using the wearable telerehabilitation system. Receives: Behavioral: Standard Home-Based Rehabilitation |
| Wearable Telerehabilitation Group | Experimental | Participants receive the same standard postoperative rehabilitation program and perform the prescribed home-based exercises using the wearable knee device connected to the telerehabilitation application, which provides exercise guidance, real-time feedback, and remote monitoring. Receives: Device: ReBK Wearable Telerehabilitation System; Behavioral: Standard Home-Based Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Active Knee Flexion Range of Motion
Active knee flexion range of motion, measured in degrees using a 360° universal goniometer. Three measurements are performed and the average value is recorded.
Measured: Preoperative baseline, weekly during postoperative weeks 1-8, and postoperative week 12.
Passive Knee Flexion Range of Motion
Passive knee flexion range of motion, measured in degrees using a 360° universal goniometer. Three measurements are performed and the average value is recorded.
Measured: Preoperative baseline, weekly during postoperative weeks 1-8, and postoperative week 12
Active Knee Extension Range of Motion
Active knee extension range of motion, measured in degrees using a 360° universal goniometer. Three measurements are performed and the average value is recorded
Measured: Preoperative baseline, weekly during postoperative weeks 1-8, and postoperative week 12
Passive Knee Extension Range of Motion
Passive knee extension range of motion, measured in degrees using a 360° universal goniometer. Three measurements are performed and the average value is recorded.
Measured: Preoperative baseline, weekly during postoperative weeks 1-8, and postoperative week 12
Isometric Quadriceps Strength
Isometric quadriceps muscle strength of the operated limb, measured in kilograms using a Tindeq dynamometer
Measured: Preoperative baseline and postoperative weeks 1, 4, 8, and approximately 12
Secondary outcomes (2)
30-Second Sit-to-Stand Test
Functional performance assessed using the 30-second Sit-to-Stand test. The number of complete sit-to-stand repetitions performed within 30 seconds is recorded
Measured: Preoperative baseline, weekly during postoperative weeks 1-8, and postoperative week 12
Usability of the Technology-Assisted Rehabilitation System
Usability of the wearable electrogoniometry-based telerehabilitation system assessed using a structured patient questionnaire. Items were rated on a 5-point Likert scale, with higher scores indicating more favorable usability ratings.
Measured: Postoperative week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start21 Sep 2026 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee Arthroplasty RecoveryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, maximiliano barahona vasquez, University of Chile
- Investigators
- Hachi Manzur, MD, Principal investigator, University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07875725
- Sponsor's protocol ID
- Acta 097-2025
- Other IDs
- ID21I10289
- Status last verified
- Oct 2026
- First submitted
- 8 Oct 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in the published article will be made available upon reasonable request.