Usability and Effectiveness of ReHub in Patients After Total Hip Arthroplasty

Hip Osteoarthritis Clinical Trial

— REHIP  

Official title:

Usability and Effectiveness of ReHub in Patients After Total Hip Arthroplasty

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04176315
• Other study ID #: DCEB07072019
• Status: Terminated
• Phase: N/A
• Start date: December 4, 2019
• Est. completion date: December 19, 2020

Study information

• Verified date: June 2021
• Source: Bio-Sensing Solutions S.L. (DyCare)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 38
• Est. completion date: December 19, 2020
• Est. primary completion date: December 19, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hip Osteoarthritis
• Osteoarthritis, Hip

Intervention

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.

Locations

Country	Name	City	State
Italy	Presidio Sanitario San Camillo	Turin	Piemonte

Sponsors (3)

Lead Sponsor	Collaborator
Bio-Sensing Solutions S.L. (DyCare)	Presidio Sanitario San Camillo, Turin, University of Turin, Italy

Country where clinical trial is conducted

Italy, 

Outcome

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