NCT04176315

Usability and Effectiveness of ReHub in Patients After Total Hip Arthroplasty

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Bio-Sensing Solutions S.L. (DyCare) · Industry
• Sex: All
• Age: 60 Years – 80 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Hip Osteoarthritis

Interventions

Type	Name	Description
OTHER	Conventional Home-based Rehabilitation Plan	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.
DEVICE	ReHub Home-based Rehabilitation Plan	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.

Timeline

• Start date: 2019-12-04
• Primary completion: 2020-12-19
• Completion: 2020-12-19
• First posted: 2019-11-25
• Last updated: 2021-06-09

Locations

1 site across 1 country: Italy