TKANCT07779122
Wearable Electrogoniometry-Based Telerehabilitation After Total Knee Arthroplasty
A study testing Wearable Electrogoniometry-Based Telerehabilitation System and Standard Home-Based Rehabilitation Program in people with TKA and Knee Osteoarthritis, run by University of Chile at 1 site in Chile.
Trial summary
This study evaluated a wearable electrogoniometry-based telerehabilitation system designed to support recovery after total knee arthroplasty. Participants followed a home-based rehabilitation program, while patients in the intervention group additionally used a wearable knee device connected to a digital application… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- TKA, Knee Osteoarthritis
- What is being tested?
- Wearable Electrogoniometry-Based Telerehabilitation System and Standard Home-Based Rehabilitation Program
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteChile
- Study dates
- 31 May 2022to 12 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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. Able to attend weekly postoperative range-of-motion 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
1 site in 1 country.
Chile1 site
Hospital Clinico Universidad de Chile
Santiago, Santiago Metropolitan, santiago
About this study
Official title: Sistema de telerrehabilitación Guiado Por electrogoniometría, lúdico y de Bajo Costo, Para la recuperación Funcional Posterior a Una Artroplastia de Rodilla en Personas Mayores
This study evaluated a wearable electrogoniometry-based telerehabilitation system designed to support recovery after total knee arthroplasty. Participants followed a home-based rehabilitation program, while patients in the intervention group additionally used a wearable knee device connected to a digital application that provided exercise guidance, real-time feedback, and remote monitoring. Knee range of motion, functional performance, and patient-reported outcomes were evaluated during postoperative recovery.
Read the detailed description
Participants were allocated sequentially in a non-randomized manner. The first 50 enrolled participants constituted the control group, and the subsequent 32 participants were allocated to the intervention group and received the wearable electrogoniometry-based telerehabilitation system. All participants underwent a preoperative baseline assessment. Following total knee arthroplasty, participants were followed weekly during the first 8 postoperative weeks, with a final assessment at 12 weeks. Clinical and functional outcomes included knee range of motion, functional performance, and self-reported assessments. Participants in the intervention group additionally completed a questionnaire evaluating the usability of and their experience with the technology-assisted rehabilitation system.
- Conditions
- TKA, Knee Osteoarthritis
- Being tested
- Wearable Electrogoniometry-Based Telerehabilitation System, Standard Home-Based Rehabilitation Program
- Keywords
- Telerehabilitation, Electrogoniometry, Wearable Technology, Total Knee Arthroplasty, Postoperative Rehabilitation, Range of Motion
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearable Electrogoniometry-Based Telerehabilitation SystemDevice
Also called RebK
Participants performed their prescribed postoperative rehabilitation exercises using the RebK wearable electrogoniometry-based telerehabilitation system. The wearable knee device was connected to a mobile application that guided exercise performance, provided real-time feedback on knee movement, and enabled remote monitoring of rehabilitation progress by the clinical team.
Standard Home-Based Rehabilitation ProgramBehavioural
A standardized home-based exercise program following total knee arthroplasty, including therapeutic exercises aimed at improving knee range of motion, muscle strength, and functional recovery. Partici
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Participants received the standard home-based rehabilitation program following total knee arthroplasty, without use of the wearable electrogoniometry-based telerehabilitation system. Receives: Behavioral: Standard Home-Based Rehabilitation Program |
| Technology-Assisted Rehabilitation Group | Experimental | Participants received the standard home-based rehabilitation program following total knee arthroplasty, supplemented with a wearable electrogoniometry-based telerehabilitation system connected to a mobile application that provided guided exercises, real-time feedback, and remote monitoring of rehabilitation progress. Receives: Device: Wearable Electrogoniometry-Based Telerehabilitation System |
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 standardized goniometry. Higher values indicate greater knee flexion.
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 standardized goniometry. Higher values indicate greater knee flexion.
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 standardized goniometry. A value of 0° indicates full knee extension, while negative values indicate an extension deficit.
Measured: Preoperative baseline, weekly during postoperative weeks 1-8, and postoperative week 12
Passive Knee Extension
Passive knee extension range of motion, measured in degrees using standardized goniometry. A value of 0° indicates full knee extension, while negative values indicate an extension deficit.
Measured: Preoperative baseline, weekly during postoperative weeks 1-8, and postoperative week 12
Secondary outcomes (2)
30-Second Sit-to-Stand Test
Functional performance assessed as the total number of complete sit-to-stand repetitions performed within 30 seconds. Higher values indicate better functional performance.
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 posted21 Aug 2026
- Study start31 May 2022
- Primary completion12 Sep 2024
- Study completion12 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TKAStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants were assigned sequentially to two parallel groups in a non-randomized manner. The first 50 enrolled participants were assigned to the control group and received the standard home-based rehabilitation program. The subsequent 32 participants were assigned to the intervention group and received the same rehabilitation program supported by the wearable electrogoniometry-based telerehabilitation system.
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
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
- NCT07779122
- Sponsor's protocol ID
- Acta 049-2021
- Other IDs
- ID21I10289
- Status last verified
- Aug 2026
- First submitted
- 18 Aug 2026
- Last updated
- 21 Aug 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sistema de telerrehabilitación Guiado Por electrogoniometría, lúdico y de Bajo Costo, Para la recuperación Funcional Posterior a Una Artroplastia de Rodilla en Personas Mayores
- ClinicalTrials.gov ID
- NCT07779122
- Acronym / sponsor ID
- Acta 049-2021
- Conditions
- TKA, Knee Osteoarthritis
- Keywords
- Telerehabilitation, Electrogoniometry, Wearable Technology, Total Knee Arthroplasty, Postoperative Rehabilitation, Range of Motion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Study start
- 31 May 2022 (actual)
- Primary completion
- 12 Sep 2024 (actual)
- Study completion
- 12 Sep 2024 (actual)
- First posted
- 21 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluated a wearable electrogoniometry-based telerehabilitation system designed to support recovery after total knee arthroplasty. Participants followed a home-based rehabilitation program, while patients in the intervention group additionally used a wearable knee device connected to a digital application that provided exercise guidance, real-time feedback, and remote monitoring. Knee range of motion, functional performance, and patient-reported outcomes were evaluated during postoperative recovery.
Detailed description
Participants were allocated sequentially in a non-randomized manner. The first 50 enrolled participants constituted the control group, and the subsequent 32 participants were allocated to the intervention group and received the wearable electrogoniometry-based telerehabilitation system. All participants underwent a preoperative baseline assessment. Following total knee arthroplasty, participants were followed weekly during the first 8 postoperative weeks, with a final assessment at 12 weeks. Clinical and functional outcomes included knee range of motion, functional performance, and self-reported assessments. Participants in the intervention group additionally completed a questionnaire evaluating the usability of and their experience with the technology-assisted rehabilitation system.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were assigned sequentially to two parallel groups in a non-randomized manner. The first 50 enrolled participants were assigned to the control group and received the standard home-based rehabilitation program. The subsequent 32 participants were assigned to the intervention group and received the same rehabilitation program supported by the wearable electrogoniometry-based telerehabilitation system.
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Behavioral: Standard Home-Based Rehabilitation ProgramParticipants received the standard home-based rehabilitation program following total knee arthroplasty, without use of the wearable electrogoniometry-based telerehabilitation system. |
| Technology-Assisted Rehabilitation Group | Experimental | Device: Wearable Electrogoniometry-Based Telerehabilitation SystemParticipants received the standard home-based rehabilitation program following total knee arthroplasty, supplemented with a wearable electrogoniometry-based telerehabilitation system connected to a mobile application that provided guided exercises, real-time feedback, and remote monitoring of rehabilitation progress. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults older than 60 years. Scheduled for primary total knee arthroplasty for knee osteoarthritis. Able to attend weekly postoperative range-of-motion assessments.
Key exclusion criteria (1 listed)
- Revision arthroplasty. Use of constrained implants. Cognitive impairment preventing adherence to rehabilitation instructions. Inability to participate in follow-up assessments.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wearable Electrogoniometry-Based Telerehabilitation SystemAlso: RebKParticipants performed their prescribed postoperative rehabilitation exercises using the RebK wearable electrogoniometry-based telerehabilitation system. The wearable knee device was connected to a mobile application that guided exercise performance, provided real-time feedback on knee movement, and enabled remote monitoring of rehabilitation progress by the clinical team. | Device | Technology-Assisted Rehabilitation Group |
| Standard Home-Based Rehabilitation ProgramA standardized home-based exercise program following total knee arthroplasty, including therapeutic exercises aimed at improving knee range of motion, muscle strength, and functional recovery. Partici | Behavioural | Control group |
Primary outcome
Active Knee Flexion Range of Motion
Time frame: Preoperative baseline, weekly during postoperative weeks 1-8, and postoperative week 12
Active knee flexion range of motion, measured in degrees using standardized goniometry. Higher values indicate greater knee flexion.
Passive Knee Flexion Range of Motion
Time frame: Preoperative baseline, weekly during postoperative weeks 1-8, and postoperative week 12
Passive knee flexion range of motion, measured in degrees using standardized goniometry. Higher values indicate greater knee flexion.
Active Knee Extension Range of Motion
Time frame: Preoperative baseline, weekly during postoperative weeks 1-8, and postoperative week 12
Active knee extension range of motion, measured in degrees using standardized goniometry. A value of 0° indicates full knee extension, while negative values indicate an extension deficit.
Passive Knee Extension
Time frame: Preoperative baseline, weekly during postoperative weeks 1-8, and postoperative week 12
Passive knee extension range of motion, measured in degrees using standardized goniometry. A value of 0° indicates full knee extension, while negative values indicate an extension deficit.
2 secondary outcomes
30-Second Sit-to-Stand Test
Time frame: Preoperative baseline, weekly during postoperative weeks 1-8, and postoperative week 12
Usability of the Technology-Assisted Rehabilitation System
Time frame: Postoperative week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in the published article will be made available upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hachi Manzur, MD principal investigator
University of Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wearable Electrogoniometry-Based Telerehabilitation System and Standard Home-Based Rehabilitation Program in people with TKA and Knee Osteoarthritis, run by University of Chile at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Active Knee Flexion Range of Motion (time frame: Preoperative baseline, weekly during postoperative weeks 1-8, and postoperative week 12). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.