Knee OsteoarthritisREHAPTNCT04155957
Evaluation of Safety and Efficacy of ReHub in Patients Who Underwent Primary Total Knee Arthroplasty
A study testing Rapid Recovery Rehabilitation Programme and ReHub in people with Knee Osteoarthritis, run by Bio-Sensing Solutions S.L. (DyCare) at 1 site in Spain.
Trial summary
This is a randomized, non-blinded, parallel assignment, clinical trial for the evaluation of safety and efficacy of ReHub, a telerehabilitation system made up of a cloud platform and an exercise kit with smart sensors, for performing rehabilitation exercises after a primary Total Knee Arthroplasty. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Rapid Recovery Rehabilitation Programme and ReHub
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteSpain
- Study dates
- 25 Nov 2019to 3 Dec 2020
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Candidates to primary TKA
- Age from 18 to 75 years old
- Ability to understand and accept the clinical study procedure and to sign an informed consent form
- Good predisposition to the use of technology or cohabitation with someone that can give them technological support
- Availability to attend the Hospital for control visits
- Patient resides in the area of influence of Hospital Clínic de Barcelona
Who cannot join
- Reluctance or inability to use technology
- Any type of disability that could alter the homogeneity of the study
- Sensory and/or cognitive impairment
- Concomitant medical conditions that may influence the rehabilitation process
- Any local or systemic complications after TKA surgery (e.g. surgical wound infection, suspicious of deep vein thrombosis)
Trial locations and contacts
1 site in 1 country.
About this study
This is a randomized, non-blinded, parallel assignment, clinical trial for the evaluation of safety and efficacy of ReHub, a telerehabilitation system made up of a cloud platform and an exercise kit with smart sensors, for performing rehabilitation exercises after a primary Total Knee Arthroplasty.
Primary TKA patients are allocated randomly to the control arm or the experimental arm with a 1:1 ratio. Both arms follow the usual rapid recovery protocol for TKA surgeries at Hospital Clínic de Barcelona, which includes discharge after 2-3 days from the surgery, the prescription of a daily plan of 5 exercises for autonomous rehabilitation and domiciliary visits by a physiotherapist starting approximately 2 weeks after the surgery. The experimental arm participants use ReHub to do their exercises instead of working independently and physiotherapists monitor their performance and adherence remotely.
Outcomes assessment is performed at hospital discharge (baseline), at stitch removal (2 weeks after baseline) and 2 weeks after stitch removal (4 weeks after baseline).
- Conditions
- Knee Osteoarthritis
- Being tested
- Rapid Recovery Rehabilitation Programme, ReHub
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapid Recovery Rehabilitation ProgrammeOther
Usual intervention at Hospital Clínic de Barcelona for post-operative rehabilitation of TKA patients. Participants, already at home after hospital discharge, must perform 5 different exercises 4 times a day (twice in the morning, twice in the afternoon).
Participants are also encouraged to walk and stretch their legs. Domiciliary visits by a physiotherapist start at approximately 2 weeks after the surgery to help participants do the exercises.
ReHubDevice
Participants use a telerehabilitation platform, ReHub, as a guide to perform the TKA rehabilitation exercises of the Rapid Recovery Rehabilitation Programme intervention.
The exercise plan in ReHub is carried out by a site physiotherapist on the first day after discharge by using ReHub to acquire the participant's movement pattern with a wearable inertial sensor that transmits data to the platform.
The wearable inertial sensor participants must wear tracks movement while they do the TKA rehabilitation exercises. Movement is analysed and feedback is given in real time. At the end of each exercise, participants can select if they have felt pain in a scale from 1 to 10. A physiotherapist monitors the participants' progress remotely.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Rehabilitation Group | Active comparator | Participants follow the usual fast-track protocol used at Hospital Clínic de Barcelona for Total Knee Arthroplasty and perform a daily 5-exercise plan autonomously. Receives: Other: Rapid Recovery Rehabilitation Programme |
| ReHub Group | Experimental | Participants follow the usual fast-track protocol used at Hospital Clínic de Barcelona for Total Knee Arthroplasty but use the telerehabilitation platform ReHub to do the exercises in their rehabilitation plan at home and to have their progress monitored. Receives: Other: Rapid Recovery Rehabilitation Programme; Device: ReHub |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Active Knee Range of Motion (º)
Range of motion of the replaced knee without the aid of the outcomes assessor will be measured with a conventional goniometer.
Measured: Baseline, 2 weeks and 4 weeks after discharge
Secondary outcomes (8)
Change in the Timed Up-and-Go test score (s)
The TUG test outcome is the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.
Measured: Baseline, 2 weeks and 4 weeks after discharge
Change in Self-Reported Pain Level: Visual Analogue Scale
The pain level will be reported by the participant with a Visual Analogue Scale from 0 to 10, with 0 being the absence of pain and 10 being the worst pain imaginable.
Measured: Baseline, 2 weeks and 4 weeks after discharge
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score
Scores for the WOMAC questionnaire range from 0 to 96, with 0 being the best state and 96 the worst state.
Measured: Baseline, 2 weeks and 4 weeks after discharge
Change in EuroQol-5D-5L (EQ-5D-5L) score
Scores for the EQ-5D-5L questionnaire are 5-digit numbers, each one representing a different aspect of quality of life. Digits can range from 1 to 5. 11111 is considered the ideal state and 55555 the worst state. 9 is used for absent or non-valid answers. The questionnaire also includes a Visual Analogue Scale for indicating perceived self's health state in a scale from 0 (worst state) to 100 (best state).
Measured: Baseline, 2 weeks and 4 weeks after discharge
Change in Quadriceps Strength (kg)
Strength of the quadriceps in the intervened leg will be measured with a dynamometer.
Measured: Baseline, 2 weeks and 4 weeks after discharge
Change in Hamstring Strength (kg)
Strength of the hamstring muscles in the intervened leg will be measured with a dynamometer.
Measured: Baseline, 2 weeks and 4 weeks after discharge
Satisfaction with ReHub: System Usability Scale
Measured with the score from the System Usability Scale questionnaire, which can range from 0 (worst result) to 100 (best result). Only for participants in the experimental arm.
Measured: 4 weeks after discharge
Change in Passive Knee Range of Motion (º)
Range of motion of the replaced knee with the aid of the outcomes assessor will be measured with a conventional goniometer.
Measured: Baseline, 2 weeks and 4 weeks after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2019
- Study start25 Nov 2019
- Primary completion3 Dec 2020
- Study completion3 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bio-Sensing Solutions S.L. (DyCare)
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hospital Clinic of Barcelona, EASME
- Responsible party
- Sponsor
- Investigators
- Salvi Prat Fabregat, Principal investigator, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04155957
- Sponsor's protocol ID
- DCEB28042019
- Acronym
- REHAPT
- Status last verified
- Jun 2021
- First submitted
- 4 Nov 2019
- Last updated
- 9 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nuevo M, Rodriguez-Rodriguez D, Jauregui R, Fabrellas N, Zabalegui A, Conti M, Prat-Fabregat S. Telerehabilitation following fast-track total knee arthroplasty is effective and safe: a randomized controlled trial with the ReHub(R) platform. Disabil Rehabil. 2024 Jun;46(12):2629-2639. doi: 10.1080/09638288.2023.2228689. Epub 2023 Jul 5.
PubMed 37403684Nuevo M, Mahdavi H, Rodriguez D, Faura T, Fabrellas N, Balocco S, Conti M, Castagna A, Prat S. Evaluation of Safety and Efficacy of ReHub in Patients Who Underwent Primary Total Knee Arthroplasty: Study Protocol for a Randomized Controlled Trial. Int J Surg Protoc. 2021 Apr 19;25(1):34-41. doi: 10.29337/ijsp.138.
PubMed 34013143
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Safety and Efficacy of ReHub in Patients Who Underwent Primary Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT04155957
- Acronym / sponsor ID
- REHAPT / DCEB28042019
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Bio-Sensing Solutions S.L. (DyCare)Industry (pharma, biotech, devices)
- Collaborators
- Hospital Clinic of Barcelona, EASME
- Study start
- 25 Nov 2019 (actual)
- Primary completion
- 3 Dec 2020 (actual)
- Study completion
- 3 Dec 2020 (actual)
- First posted
- 7 Nov 2019 (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 is a randomized, non-blinded, parallel assignment, clinical trial for the evaluation of safety and efficacy of ReHub, a telerehabilitation system made up of a cloud platform and an exercise kit with smart sensors, for performing rehabilitation exercises after a primary Total Knee Arthroplasty.
Primary TKA patients are allocated randomly to the control arm or the experimental arm with a 1:1 ratio. Both arms follow the usual rapid recovery protocol for TKA surgeries at Hospital Clínic de Barcelona, which includes discharge after 2-3 days from the surgery, the prescription of a daily plan of 5 exercises for autonomous rehabilitation and domiciliary visits by a physiotherapist starting approximately 2 weeks after the surgery. The experimental arm participants use ReHub to do their exercises instead of working independently and physiotherapists monitor their performance and adherence remotely.
Outcomes assessment is performed at hospital discharge (baseline), at stitch removal (2 weeks after baseline) and 2 weeks after stitch removal (4 weeks after baseline).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Rehabilitation Group | Active comparator | Other: Rapid Recovery Rehabilitation ProgrammeParticipants follow the usual fast-track protocol used at Hospital Clínic de Barcelona for Total Knee Arthroplasty and perform a daily 5-exercise plan autonomously. |
| ReHub Group | Experimental | Other: Rapid Recovery Rehabilitation Programme, Device: ReHubParticipants follow the usual fast-track protocol used at Hospital Clínic de Barcelona for Total Knee Arthroplasty but use the telerehabilitation platform ReHub to do the exercises in their rehabilitation plan at home and to have their progress monitored. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Candidates to primary TKA
- Age from 18 to 75 years old
- Ability to understand and accept the clinical study procedure and to sign an informed consent form
- Good predisposition to the use of technology or cohabitation with someone that can give them technological support
- Availability to attend the Hospital for control visits
Key exclusion criteria (5 listed)
- Reluctance or inability to use technology
- Any type of disability that could alter the homogeneity of the study
- Sensory and/or cognitive impairment
- Concomitant medical conditions that may influence the rehabilitation process
- Any local or systemic complications after TKA surgery (e.g. surgical wound infection, suspicious of deep vein thrombosis)
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 |
|---|---|---|
| Rapid Recovery Rehabilitation ProgrammeUsual intervention at Hospital Clínic de Barcelona for post-operative rehabilitation of TKA patients. Participants, already at home after hospital discharge, must perform 5 different exercises 4 times a day (twice in the morning, twice in the afternoon). Participants are also encouraged to walk and stretch their legs. Domiciliary visits by a physiotherapist start at approximately 2 weeks after the surgery to help participants do the exercises. | Other | Conventional Rehabilitation Group, ReHub Group |
| ReHubParticipants use a telerehabilitation platform, ReHub, as a guide to perform the TKA rehabilitation exercises of the Rapid Recovery Rehabilitation Programme intervention. The exercise plan in ReHub is carried out by a site physiotherapist on the first day after discharge by using ReHub to acquire the participant's movement pattern with a wearable inertial sensor that transmits data to the platform. The wearable inertial sensor participants must wear tracks movement while they do the TKA rehabilitation exercises. Movement is analysed and feedback is given in real time. At the end of each exercise, participants can select if they have felt pain in a scale from 1 to 10. A physiotherapist monitors the participants' progress remotely. | Device | ReHub Group |
Primary outcome
Change in Active Knee Range of Motion (º)
Time frame: Baseline, 2 weeks and 4 weeks after discharge
Range of motion of the replaced knee without the aid of the outcomes assessor will be measured with a conventional goniometer.
8 secondary outcomes
Change in the Timed Up-and-Go test score (s)
Time frame: Baseline, 2 weeks and 4 weeks after discharge
Change in Self-Reported Pain Level: Visual Analogue Scale
Time frame: Baseline, 2 weeks and 4 weeks after discharge
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score
Time frame: Baseline, 2 weeks and 4 weeks after discharge
Change in EuroQol-5D-5L (EQ-5D-5L) score
Time frame: Baseline, 2 weeks and 4 weeks after discharge
Change in Quadriceps Strength (kg)
Time frame: Baseline, 2 weeks and 4 weeks after discharge
Change in Hamstring Strength (kg)
Time frame: Baseline, 2 weeks and 4 weeks after discharge
Satisfaction with ReHub: System Usability Scale
Time frame: 4 weeks after discharge
Change in Passive Knee Range of Motion (º)
Time frame: Baseline, 2 weeks and 4 weeks after discharge
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 9 Jun 2021.
- Derived from this study: PubMed 37403684Nuevo M, Rodriguez-Rodriguez D, Jauregui R, Fabrellas N, Zabalegui A, Conti M, Prat-Fabregat S. Telerehabilitation following fast-track total knee arthroplasty is effective and safe: a randomized controlled trial with the ReHub(R) platform. Disabil Rehabil. 2024 Jun;46(12):2629-2639. doi: 10.1080/09638288.2023.2228689. Epub 2023 Jul 5.
- Derived from this study: PubMed 34013143Nuevo M, Mahdavi H, Rodriguez D, Faura T, Fabrellas N, Balocco S, Conti M, Castagna A, Prat S. Evaluation of Safety and Efficacy of ReHub in Patients Who Underwent Primary Total Knee Arthroplasty: Study Protocol for a Randomized Controlled Trial. Int J Surg Protoc. 2021 Apr 19;25(1):34-41. doi: 10.29337/ijsp.138.
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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.
Salvi Prat Fabregat principal investigator
Hospital Clinic of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rapid Recovery Rehabilitation Programme and ReHub in people with Knee Osteoarthritis, run by Bio-Sensing Solutions S.L. (DyCare) at 1 site in Spain.
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 6 inclusion and 5 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 9 Jun 2021. 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 Spain. 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?
Change in Active Knee Range of Motion (º) (time frame: Baseline, 2 weeks and 4 weeks after discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04155957, which also lists 2 linked publications.
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 9 Jun 2021.