Usability and Effectiveness of ReHub in Patients After Total Hip Arthroplasty
- Conditions
- Hip Osteoarthritis
- Interventions
- Other: Conventional Home-based Rehabilitation PlanDevice: ReHub Home-based Rehabilitation Plan
- Registration Number
- NCT04176315
- Lead Sponsor
- Bio-Sensing Solutions S.L. (DyCare)
- Brief 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).
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 38
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Conventional Rehabilitation Group Conventional Home-based Rehabilitation Plan Participants follow the usual exercise plan designed at Presidio San Camillo for Total Hip Arthroplasty autonomously ReHub Group ReHub Home-based Rehabilitation Plan 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.
- Primary Outcome Measures
Name Time Method Change in the Timed Up-and-Go test score (s) 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.
- Secondary Outcome Measures
Name Time Method Change in Hip Extension Range of Motion (º) Baseline, 2 weeks and 5 weeks from baseline Range of motion of the replaced hip for extension, without the aid of the outcomes assessor, is measured with a conventional goniometer.
Change in Hip Flexion Range of Motion (º) Baseline, 2 weeks and 5 weeks from baseline Range of motion of the replaced hip for flexion, without the aid of the outcomes assessor, is measured with a conventional goniometer.
Change in Hip Abduction Range of Motion (º) Baseline, 2 weeks and 5 weeks from baseline Range of motion of the replaced hip for abduction, without the aid of the outcomes assessor, is measured with a conventional goniometer.
Change in Abduction Strength (kg) Baseline, 2 weeks and 5 weeks from baseline Strength of the intervened leg while performing an abduction movement is measured with a dynamometer.
Change in Quadriceps Strength (kg) Baseline, 2 weeks and 5 weeks from baseline Strength of the quadriceps in the intervened leg is measured with a dynamometer.
Satisfaction with ReHub: System Usability Scale 5 weeks from baseline 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.
Change in Extension Strength (kg) Baseline, 2 weeks and 5 weeks from baseline Strength of the intervened leg while performing an extension movement is measured with a dynamometer.
Global Rating Of Change 5 weeks from baseline 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).
Change in Self-Reported Pain Level in Movement: Numerical Rating Scale Baseline, 2 weeks and 5 weeks from baseline 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.
Change in Hip disability and Osteoarthritis Outcome Score (HOOS) Baseline, 2 weeks and 5 weeks from baseline Scores for the HOOS questionnaire range from 0% to 100%, with 0 being the worst possible score and 100 the best possible score.
Change in Functional Independence Measure (FIM) score Baseline, 2 weeks and 5 weeks from baseline 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).
Change in Self-Reported Pain Level at Rest: Numerical Rating Scale Baseline, 2 weeks and 5 weeks from baseline 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.
Trial Locations
- Locations (1)
Presidio Sanitario San Camillo
🇮🇹Turin, Piemonte, Italy