Usability and Effectiveness of ReHub in Patients After Total Hip Arthroplasty

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-04

Study Completion Date

2020-12-19

Brief Summary

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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).

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Detailed Description

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Conditions

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Hip Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Conventional Rehabilitation Group

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

Group Type ACTIVE_COMPARATOR

Conventional Home-based Rehabilitation Plan

Intervention Type OTHER

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 Group

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.

Group Type EXPERIMENTAL

ReHub Home-based Rehabilitation Plan

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type OTHER

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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

60 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No