Hip OsteoarthritisREHIPNCT04176315
Usability and Effectiveness of ReHub in Patients After Total Hip Arthroplasty
A study testing Conventional Home-based Rehabilitation Plan and ReHub Home-based Rehabilitation Plan in people with Hip Osteoarthritis, run by Bio-Sensing Solutions S.L. (DyCare) at 1 site in Italy.
Trial summary
This is a randomized, non-blinded, parallel assignment, clinical trial for the evaluation of usability and effectiveness 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 Hip Arthroplasty (THA). Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Hip Osteoarthritis
- What is being tested?
- Conventional Home-based Rehabilitation Plan and ReHub Home-based Rehabilitation Plan
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteItaly
- Study dates
- 4 Dec 2019to 19 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 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to understand and accept the clinical study procedure and to sign an informed consent form
- Good familiarity with the Italian language
- Good predisposition to the use of technology or availability of a caregiver providing technological support to the patient
- Availability to move to the Rehabilitation Center for control visits
Who cannot join
- Age <60 or >80 years
- Admission after THA revision surgery
- Contralateral hip osteoarthritis severely limiting patient mobility and ability to comply with a rehabilitation program
- Aphasia, dementia, or psychiatric comorbidity interfering with communication or adherence to the rehabilitation process
- Respiratory, cardiac, metabolic, or other condition limiting patient mobility and ability to comply with a rehabilitation program
- Major medical complications occurring after surgery that prevented the discharge of the patient within 10 days after the surgery
- Body mass index >35kg/m2
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 usability and effectiveness 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 Hip Arthroplasty (THA).
Patients admitted to Presidio San Camillo after a THA surgery are randomly allocated to the control arm or the experimental arm with a 1:1 ratio. Participants in both arms receive inpatient care and rehabilitation for 2 weeks at San Camillo. At discharge, they are prescribed with the same daily plan of 5 exercises for autonomous home-based rehabilitation. 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 San Camillo admission (baseline), at San Camillo discharge (2 weeks from baseline) and 3 weeks after San Camillo discharge (5 weeks from baseline).
- Conditions
- Hip Osteoarthritis
- Being tested
- Conventional Home-based Rehabilitation Plan, ReHub Home-based Rehabilitation Plan
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Home-based Rehabilitation PlanOther
Usual intervention at Presidio Sanitario San Camillo for post-operative rehabilitation of THA patients. Participants receive inpatient care and rehabilitation for 2 weeks. At discharge, they receive a 5-exercise home-based rehabilitation plan. For the sake of homogeneity of all participants, they receive from 2 to 4 of training prior to discharge. At home, participants shall perform the exercises in the rehabilitation plan daily.
ReHub Home-based Rehabilitation PlanDevice
Combination of the usual intervention at Presidio Sanitario San Camillo for post-operative rehabilitation of THA patients with ReHub, a telerehabilitation platform that serves as a guide to perform the TKA rehabilitation exercises.
Participants receive inpatient care and rehabilitation at San Camillo for 2 weeks. At discharge, a 5-exercise home-based rehabilitation plan is carried out by a site physiotherapist by using ReHub to acquire the participant's movement pattern with a wearable inertial sensor. Participants receive from 2 to 4 sessions of ReHub prior to discharge.
At home, participants shall perform the exercises in the rehabilitation plan with ReHub daily. 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. 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 exercise plan designed at Presidio San Camillo for Total Hip Arthroplasty autonomously Receives: Other: Conventional Home-based Rehabilitation Plan |
| ReHub Group | Experimental | Participants follow the usual exercise plan designed at Presidio San Camillo for Total Hip Arthroplasty but use the telerehabilitation platform ReHub to do the exercises at home and to have their progress monitored. Receives: Device: ReHub Home-based Rehabilitation Plan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 as the score.
Measured: Baseline, 2 weeks and 5 weeks from baseline
Secondary outcomes (12)
Change in Hip Flexion Range of Motion (º)
Range of motion of the replaced hip for flexion, without the aid of the outcomes assessor, is measured with a conventional goniometer.
Measured: Baseline, 2 weeks and 5 weeks from baseline
Change in Hip Extension Range of Motion (º)
Range of motion of the replaced hip for extension, without the aid of the outcomes assessor, is measured with a conventional goniometer.
Measured: Baseline, 2 weeks and 5 weeks from baseline
Change in Hip Abduction Range of Motion (º)
Range of motion of the replaced hip for abduction, without the aid of the outcomes assessor, is measured with a conventional goniometer.
Measured: Baseline, 2 weeks and 5 weeks from baseline
Change in Quadriceps Strength (kg)
Strength of the quadriceps in the intervened leg is measured with a dynamometer.
Measured: Baseline, 2 weeks and 5 weeks from baseline
Change in Extension Strength (kg)
Strength of the intervened leg while performing an extension movement is measured with a dynamometer.
Measured: Baseline, 2 weeks and 5 weeks from baseline
Change in Abduction Strength (kg)
Strength of the intervened leg while performing an abduction movement is measured with a dynamometer.
Measured: Baseline, 2 weeks and 5 weeks from baseline
Change in Self-Reported Pain Level at Rest: Numerical Rating Scale
The pain level of the intervened hip at rest is reported by the participant with a Numerical Rating Scale from 0 to 10, with 0 being the absence of pain and 100 being the worst possible pain.
Measured: Baseline, 2 weeks and 5 weeks from baseline
Change in Self-Reported Pain Level in Movement: Numerical Rating Scale
The pain level of the intervened hip in movement is reported by the participant with a Numerical Rating Scale from 0 to 10, with 0 being the absence of pain and 100 being the worst possible pain.
Measured: Baseline, 2 weeks and 5 weeks from baseline
Change in Hip disability and Osteoarthritis Outcome Score (HOOS)
Scores for the HOOS questionnaire range from 0% to 100%, with 0 being the worst possible score and 100 the best possible score.
Measured: Baseline, 2 weeks and 5 weeks from baseline
Change in Functional Independence Measure (FIM) score
Scores for the FIM questionnaire range from 18 to 126, with 13 being the worst possible score and 100 the best possible score. Individual items (18) are scored from 1 (worst) to 7 (best).
Measured: Baseline, 2 weeks and 5 weeks from baseline
Global Rating Of Change
The participant will report their perception of change from the start to the end of the study with a number from 1 (substantial worsening) to 6 (total recovery).
Measured: 5 weeks from baseline
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: 5 weeks from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2019
- Study start4 Dec 2019
- Primary completion19 Dec 2020
- Study completion19 Dec 2020
Why it stopped: COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hip 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
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bio-Sensing Solutions S.L. (DyCare)
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Turin, Italy, Presidio Sanitario San Camillo, Turin
- Responsible party
- Sponsor
- Investigators
- Marco Alessandro Minetto, Principal investigator, University of Turin, Department of Surgical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04176315
- Sponsor's protocol ID
- DCEB07072019
- Acronym
- REHIP
- Status last verified
- Jun 2021
- First submitted
- 22 Nov 2019
- Last updated
- 9 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Busso C, Castorina G, Di Monaco M, Rodriguez D, Mahdavi H, Balocco S, Trucco M, Conti M, Castagna A, Minetto MA. Effectiveness of a home-based telerehabilitation system in patients after total hip arthroplasty: study protocol of a randomized controlled trial. Trials. 2020 Oct 14;21(1):852. doi: 10.1186/s13063-020-04791-4.
PubMed 33054811
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
- Usability and Effectiveness of ReHub in Patients After Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT04176315
- Acronym / sponsor ID
- REHIP / DCEB07072019
- Conditions
- Hip Osteoarthritis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Bio-Sensing Solutions S.L. (DyCare)Industry (pharma, biotech, devices)
- Collaborators
- University of Turin, Italy, Presidio Sanitario San Camillo, Turin
- Study start
- 4 Dec 2019 (actual)
- Primary completion
- 19 Dec 2020 (actual)
- Study completion
- 19 Dec 2020 (actual)
- First posted
- 25 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 usability and effectiveness 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 Hip Arthroplasty (THA).
Patients admitted to Presidio San Camillo after a THA surgery are randomly allocated to the control arm or the experimental arm with a 1:1 ratio. Participants in both arms receive inpatient care and rehabilitation for 2 weeks at San Camillo. At discharge, they are prescribed with the same daily plan of 5 exercises for autonomous home-based rehabilitation. 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 San Camillo admission (baseline), at San Camillo discharge (2 weeks from baseline) and 3 weeks after San Camillo discharge (5 weeks from 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: Conventional Home-based Rehabilitation PlanParticipants follow the usual exercise plan designed at Presidio San Camillo for Total Hip Arthroplasty autonomously |
| ReHub Group | Experimental | Device: ReHub Home-based Rehabilitation PlanParticipants follow the usual exercise plan designed at Presidio San Camillo for Total Hip Arthroplasty but use the telerehabilitation platform ReHub to do the exercises at home and to have their progress monitored. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ability to understand and accept the clinical study procedure and to sign an informed consent form
- Good familiarity with the Italian language
- Good predisposition to the use of technology or availability of a caregiver providing technological support to the patient
- Availability to move to the Rehabilitation Center for control visits
Key exclusion criteria (7 listed)
- Age <60 or >80 years
- Admission after THA revision surgery
- Contralateral hip osteoarthritis severely limiting patient mobility and ability to comply with a rehabilitation program
- Aphasia, dementia, or psychiatric comorbidity interfering with communication or adherence to the rehabilitation process
- Respiratory, cardiac, metabolic, or other condition limiting patient mobility and ability to comply with a rehabilitation program
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 |
|---|---|---|
| Conventional Home-based Rehabilitation PlanUsual intervention at Presidio Sanitario San Camillo for post-operative rehabilitation of THA patients. Participants receive inpatient care and rehabilitation for 2 weeks. At discharge, they receive a 5-exercise home-based rehabilitation plan. For the sake of homogeneity of all participants, they receive from 2 to 4 of training prior to discharge. At home, participants shall perform the exercises in the rehabilitation plan daily. | Other | Conventional Rehabilitation Group |
| ReHub Home-based Rehabilitation PlanCombination of the usual intervention at Presidio Sanitario San Camillo for post-operative rehabilitation of THA patients with ReHub, a telerehabilitation platform that serves as a guide to perform the TKA rehabilitation exercises. Participants receive inpatient care and rehabilitation at San Camillo for 2 weeks. At discharge, a 5-exercise home-based rehabilitation plan is carried out by a site physiotherapist by using ReHub to acquire the participant's movement pattern with a wearable inertial sensor. Participants receive from 2 to 4 sessions of ReHub prior to discharge. At home, participants shall perform the exercises in the rehabilitation plan with ReHub daily. 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. 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 the Timed Up-and-Go test score (s)
Time frame: Baseline, 2 weeks and 5 weeks from baseline
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 as the score.
12 secondary outcomes
Change in Hip Flexion Range of Motion (º)
Time frame: Baseline, 2 weeks and 5 weeks from baseline
Change in Hip Extension Range of Motion (º)
Time frame: Baseline, 2 weeks and 5 weeks from baseline
Change in Hip Abduction Range of Motion (º)
Time frame: Baseline, 2 weeks and 5 weeks from baseline
Change in Quadriceps Strength (kg)
Time frame: Baseline, 2 weeks and 5 weeks from baseline
Change in Extension Strength (kg)
Time frame: Baseline, 2 weeks and 5 weeks from baseline
Change in Abduction Strength (kg)
Time frame: Baseline, 2 weeks and 5 weeks from baseline
Change in Self-Reported Pain Level at Rest: Numerical Rating Scale
Time frame: Baseline, 2 weeks and 5 weeks from baseline
Change in Self-Reported Pain Level in Movement: Numerical Rating Scale
Time frame: Baseline, 2 weeks and 5 weeks from baseline
Change in Hip disability and Osteoarthritis Outcome Score (HOOS)
Time frame: Baseline, 2 weeks and 5 weeks from baseline
Change in Functional Independence Measure (FIM) score
Time frame: Baseline, 2 weeks and 5 weeks from baseline
Global Rating Of Change
Time frame: 5 weeks from baseline
Satisfaction with ReHub: System Usability Scale
Time frame: 5 weeks from baseline
Results and safety
The study was stopped early (reason given: COVID-19). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2021.
- Derived from this study: PubMed 33054811Busso C, Castorina G, Di Monaco M, Rodriguez D, Mahdavi H, Balocco S, Trucco M, Conti M, Castagna A, Minetto MA. Effectiveness of a home-based telerehabilitation system in patients after total hip arthroplasty: study protocol of a randomized controlled trial. Trials. 2020 Oct 14;21(1):852. doi: 10.1186/s13063-020-04791-4.
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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.
Marco Alessandro Minetto principal investigator
University of Turin, Department of Surgical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Home-based Rehabilitation Plan and ReHub Home-based Rehabilitation Plan in people with Hip Osteoarthritis, run by Bio-Sensing Solutions S.L. (DyCare) at 1 site in Italy.
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 4 inclusion and 7 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: stopped early, 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 Italy. 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 was stopped early (reason given: COVID-19). Results are not available in the source record.
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 the Timed Up-and-Go test score (s) (time frame: Baseline, 2 weeks and 5 weeks from baseline). 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 NCT04176315, which also lists 1 linked publication.
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.