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

June 7, 2021 updated by: Bio-Sensing Solutions S.L. (DyCare)

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Piemonte
      • Turin, Piemonte, Italy, 10131
        • Presidio Sanitario San Camillo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Conventional Rehabilitation Group
Participants follow the usual exercise plan designed at Presidio San Camillo for Total Hip Arthroplasty autonomously
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.
EXPERIMENTAL: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the Timed Up-and-Go test score (s)
Time Frame: 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.
Baseline, 2 weeks and 5 weeks from baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Hip Flexion Range of Motion (º)
Time Frame: 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.
Baseline, 2 weeks and 5 weeks from baseline
Change in Hip Extension Range of Motion (º)
Time Frame: 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.
Baseline, 2 weeks and 5 weeks from baseline
Change in Hip Abduction Range of Motion (º)
Time Frame: 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.
Baseline, 2 weeks and 5 weeks from baseline
Change in Quadriceps Strength (kg)
Time Frame: Baseline, 2 weeks and 5 weeks from baseline
Strength of the quadriceps in the intervened leg is measured with a dynamometer.
Baseline, 2 weeks and 5 weeks from baseline
Change in Extension Strength (kg)
Time Frame: Baseline, 2 weeks and 5 weeks from baseline
Strength of the intervened leg while performing an extension movement is measured with a dynamometer.
Baseline, 2 weeks and 5 weeks from baseline
Change in Abduction Strength (kg)
Time Frame: Baseline, 2 weeks and 5 weeks from baseline
Strength of the intervened leg while performing an abduction movement is measured with a dynamometer.
Baseline, 2 weeks and 5 weeks from baseline
Change in Self-Reported Pain Level at Rest: Numerical Rating Scale
Time Frame: 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.
Baseline, 2 weeks and 5 weeks from baseline
Change in Self-Reported Pain Level in Movement: Numerical Rating Scale
Time Frame: 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.
Baseline, 2 weeks and 5 weeks from baseline
Change in Hip disability and Osteoarthritis Outcome Score (HOOS)
Time Frame: 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.
Baseline, 2 weeks and 5 weeks from baseline
Change in Functional Independence Measure (FIM) score
Time Frame: 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).
Baseline, 2 weeks and 5 weeks from baseline
Global Rating Of Change
Time Frame: 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).
5 weeks from baseline
Satisfaction with ReHub: System Usability Scale
Time Frame: 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.
5 weeks from baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bio-Sensing Solutions S.L. (DyCare)

Collaborators

University of Turin, Italy
Presidio Sanitario San Camillo, Turin

Investigators

  • Principal Investigator: Marco Alessandro Minetto, University of Turin, Department of Surgical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 4, 2019

Primary Completion (ACTUAL)

December 19, 2020

Study Completion (ACTUAL)

December 19, 2020

Study Registration Dates

First Submitted

November 22, 2019

First Submitted That Met QC Criteria

November 22, 2019

First Posted (ACTUAL)

November 25, 2019

Study Record Updates

Last Update Posted (ACTUAL)

June 9, 2021

Last Update Submitted That Met QC Criteria

June 7, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DCEB07072019

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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