Usability and Effectiveness of ReHub in Patients After Total Hip Arthroplasty

NCT04176315 | Terminated

• 1 other identifier: DCEB07072019
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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).

Conditions

Hip Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Change in the Timed Up-and-Go test score (s)

  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 Outcomes (12)

• Change in Hip Flexion Range of Motion (º)

  Baseline, 2 weeks and 5 weeks from baseline

• Change in Hip Extension Range of Motion (º)

  Baseline, 2 weeks and 5 weeks from baseline

• Change in Hip Abduction Range of Motion (º)

  Baseline, 2 weeks and 5 weeks from baseline

• Change in Quadriceps Strength (kg)

  Baseline, 2 weeks and 5 weeks from baseline

• Change in Extension Strength (kg)

  Baseline, 2 weeks and 5 weeks from baseline

Study Arms (2)

Conventional Rehabilitation Group

ACTIVE COMPARATOR

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

Other: Conventional Home-based Rehabilitation Plan

ReHub Group

EXPERIMENTAL

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

Interventions

Conventional Home-based Rehabilitation Plan 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.

Conventional Rehabilitation Group

ReHub Home-based Rehabilitation Plan 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.

ReHub Group

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bio-Sensing Solutions S.L. (DyCare): lead
• University of Turin, Italy: collaborator
• Presidio Sanitario San Camillo, Turin: collaborator

Study Sites (1)

Presidio Sanitario San Camillo

Turin, Piedmont, 10131, Italy

Location

Related Publications (1)

• 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.

  PMID: 33054811 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Marco Alessandro Minetto

  University of Turin, Department of Surgical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2019
• First Posted: November 25, 2019
• Study Start: December 4, 2019
• Primary Completion: December 19, 2020
• Study Completion: December 19, 2020
• Last Updated: June 9, 2021

Record last verified: 2021-06

Locations

IT (1)