Usability and Effectiveness of ReHub in Patients After Total Hip Arthroplasty (REHIP)

DyCare

Status: Terminated

Conditions: Hip Osteoarthritis

Treatments: Device: ReHub Home-based Rehabilitation Plan; Other: Conventional Home-based Rehabilitation Plan

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04176315

DCEB07072019

Details and patient eligibility

About

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).

Enrollment: 38 patients

Sex: All

Ages: 60 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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38 participants in 2 patient groups

Conventional Rehabilitation Group

Active Comparator group

Description:

Participants follow the usual exercise plan designed at Presidio San Camillo for Total Hip Arthroplasty autonomously

Treatment:

Other: Conventional Home-based Rehabilitation Plan

ReHub Group

Experimental group

Description:

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.

Treatment:

Device: ReHub Home-based Rehabilitation Plan