Evaluation of Safety and Efficacy of ReHub in Patients Who Underwent Primary Total Knee Arthroplasty (REHAPT)

This is a randomized, non-blinded, parallel assignment, clinical trial for the evaluation of safety and efficacy 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 Knee Arthroplasty.

Primary TKA patients are allocated randomly to the control arm or the experimental arm with a 1:1 ratio. Both arms follow the usual rapid recovery protocol for TKA surgeries at Hospital Clínic de Barcelona, which includes discharge after 2-3 days from the surgery, the prescription of a daily plan of 5 exercises for autonomous rehabilitation and domiciliary visits by a physiotherapist starting approximately 2 weeks after the surgery. 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 hospital discharge (baseline), at stitch removal (2 weeks after baseline) and 2 weeks after stitch removal (4 weeks after baseline).

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Other: Rapid Recovery Rehabilitation Programme; Device: ReHub

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08036
    • Hospital Clinic of Barcelona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Candidates to primary TKA
• Age from 18 to 75 years old
• Ability to understand and accept the clinical study procedure and to sign an informed consent form
• Good predisposition to the use of technology or cohabitation with someone that can give them technological support
• Availability to attend the Hospital for control visits
• Patient resides in the area of influence of Hospital Clínic de Barcelona

Exclusion Criteria:

• Reluctance or inability to use technology
• Any type of disability that could alter the homogeneity of the study
• Sensory and/or cognitive impairment
• Concomitant medical conditions that may influence the rehabilitation process
• Any local or systemic complications after TKA surgery (e.g. surgical wound infection, suspicious of deep vein thrombosis)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Conventional Rehabilitation Group; Participants follow the usual fast-track protocol used at Hospital Clínic de Barcelona for Total Knee Arthroplasty and perform a daily 5-exercise plan autonomously.	Other: Rapid Recovery Rehabilitation Programme; Usual intervention at Hospital Clínic de Barcelona for post-operative rehabilitation of TKA patients. Participants, already at home after hospital discharge, must perform 5 different exercises 4 times a day (twice in the morning, twice in the afternoon). Participants are also encouraged to walk and stretch their legs. Domiciliary visits by a physiotherapist start at approximately 2 weeks after the surgery to help participants do the exercises.
EXPERIMENTAL: ReHub Group; Participants follow the usual fast-track protocol used at Hospital Clínic de Barcelona for Total Knee Arthroplasty but use the telerehabilitation platform ReHub to do the exercises in their rehabilitation plan at home and to have their progress monitored.	Other: Rapid Recovery Rehabilitation Programme; Usual intervention at Hospital Clínic de Barcelona for post-operative rehabilitation of TKA patients. Participants, already at home after hospital discharge, must perform 5 different exercises 4 times a day (twice in the morning, twice in the afternoon). Participants are also encouraged to walk and stretch their legs. Domiciliary visits by a physiotherapist start at approximately 2 weeks after the surgery to help participants do the exercises.; Device: ReHub; Participants use a telerehabilitation platform, ReHub, as a guide to perform the TKA rehabilitation exercises of the Rapid Recovery Rehabilitation Programme intervention. The exercise plan in ReHub is carried out by a site physiotherapist on the first day after discharge by using ReHub to acquire the participant's movement pattern with a wearable inertial sensor that transmits data to the platform. 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. At the end of each exercise, 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 Active Knee Range of Motion (º)	Range of motion of the replaced knee without the aid of the outcomes assessor will be measured with a conventional goniometer.	Baseline, 2 weeks and 4 weeks after discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, 2 weeks and 4 weeks after discharge
Change in Self-Reported Pain Level: Visual Analogue Scale	The pain level will be reported by the participant with a Visual Analogue Scale from 0 to 10, with 0 being the absence of pain and 10 being the worst pain imaginable.	Baseline, 2 weeks and 4 weeks after discharge
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score	Scores for the WOMAC questionnaire range from 0 to 96, with 0 being the best state and 96 the worst state.	Baseline, 2 weeks and 4 weeks after discharge
Change in EuroQol-5D-5L (EQ-5D-5L) score	Scores for the EQ-5D-5L questionnaire are 5-digit numbers, each one representing a different aspect of quality of life. Digits can range from 1 to 5. 11111 is considered the ideal state and 55555 the worst state. 9 is used for absent or non-valid answers. The questionnaire also includes a Visual Analogue Scale for indicating perceived self's health state in a scale from 0 (worst state) to 100 (best state).	Baseline, 2 weeks and 4 weeks after discharge
Change in Quadriceps Strength (kg)	Strength of the quadriceps in the intervened leg will be measured with a dynamometer.	Baseline, 2 weeks and 4 weeks after discharge
Change in Hamstring Strength (kg)	Strength of the hamstring muscles in the intervened leg will be measured with a dynamometer.	Baseline, 2 weeks and 4 weeks after discharge
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.	4 weeks after discharge
Change in Passive Knee Range of Motion (º)	Range of motion of the replaced knee with the aid of the outcomes assessor will be measured with a conventional goniometer.	Baseline, 2 weeks and 4 weeks after discharge

Collaborators and Investigators

• Sponsor: Bio-Sensing Solutions S.L. (DyCare)
• Collaborators: Hospital Clinic of Barcelona; EASME
• Investigators: Principal Investigator: Salvi Prat Fabregat, Hospital Clinic of Barcelona

Publications and helpful links

General Publications

• Nuevo M, Mahdavi H, Rodriguez D, Faura T, Fabrellas N, Balocco S, Conti M, Castagna A, Prat S. Evaluation of Safety and Efficacy of ReHub in Patients Who Underwent Primary Total Knee Arthroplasty: Study Protocol for a Randomized Controlled Trial. Int J Surg Protoc. 2021 Apr 19;25(1):34-41. doi: 10.29337/ijsp.138.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 25, 2019
• Primary Completion (ACTUAL): December 3, 2020
• Study Completion (ACTUAL): December 3, 2020

Study Registration Dates

• First Submitted: November 4, 2019
• First Submitted That Met QC Criteria: November 5, 2019
• First Posted (ACTUAL): November 7, 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: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: DCEB28042019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No