Clinical trial NCT04176315: Usability and Effectiveness of ReHub in Patients After Total Hip Arthroplasty
Official title: Usability and Effectiveness of ReHub in Patients After Total Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hip Osteoarthritis
Lead sponsor: Bio-Sensing Solutions S.L. (DyCare)
Sponsor class: INDUSTRY
Collaborators: name: University of Turin, Italy
name: Presidio Sanitario San Camillo, Turin
First posted: 2019-11-25
Enrollment: 38
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in the Timed Up-and-Go test score (s)
timeFrame: Baseline, 2 weeks and 5 weeks from baseline
Secondary outcomes:
measure: Change in Hip Flexion Range of Motion (º)
timeFrame: Baseline, 2 weeks and 5 weeks from baseline
measure: Change in Hip Extension Range of Motion (º)
timeFrame: Baseline, 2 weeks and 5 weeks from baseline
measure: Change in Hip Abduction Range of Motion (º)
timeFrame: Baseline, 2 weeks and 5 weeks from baseline
measure: Change in Quadriceps Strength (kg)
timeFrame: Baseline, 2 weeks and 5 weeks from baseline
measure: Change in Extension Strength (kg)
timeFrame: Baseline, 2 weeks and 5 weeks from baseline
measure: Change in Abduction Strength (kg)
timeFrame: Baseline, 2 weeks and 5 weeks from baseline
measure: Change in Self-Reported Pain Level at Rest: Numerical Rating Scale
timeFrame: Baseline, 2 weeks and 5 weeks from baseline
measure: Change in Self-Reported Pain Level in Movement: Numerical Rating Scale
timeFrame: Baseline, 2 weeks and 5 weeks from baseline
measure: Change in Hip disability and Osteoarthritis Outcome Score (HOOS)
timeFrame: Baseline, 2 weeks and 5 weeks from baseline
measure: Change in Functional Independence Measure (FIM) score
timeFrame: Baseline, 2 weeks and 5 weeks from baseline
measure: Global Rating Of Change
timeFrame: 5 weeks from baseline
measure: Satisfaction with ReHub: System Usability Scale
timeFrame: 5 weeks from baseline
Other outcomes:
Locations:
city: Turin
country: Italy
facility: Presidio Sanitario San Camillo
state: Piemonte
Study officials:
affiliation: University of Turin, Department of Surgical Sciences
name: Marco Alessandro Minetto
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.