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

NCT04155957 | Completed

• 1 other identifier: DCEB28042019
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

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

  Baseline, 2 weeks and 4 weeks after discharge

• Change in Self-Reported Pain Level: Visual Analogue Scale

  Baseline, 2 weeks and 4 weeks after discharge

• Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score

  Baseline, 2 weeks and 4 weeks after discharge

• Change in EuroQol-5D-5L (EQ-5D-5L) score

  Baseline, 2 weeks and 4 weeks after discharge

• Change in Quadriceps Strength (kg)

  Baseline, 2 weeks and 4 weeks after discharge

Study Arms (2)

Conventional Rehabilitation Group

ACTIVE COMPARATOR

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

ReHub Group

EXPERIMENTAL

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; Device: ReHub

Interventions

Rapid Recovery Rehabilitation Programme OTHER

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.

Conventional Rehabilitation Group; ReHub Group

ReHub DEVICE

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.

ReHub Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Bio-Sensing Solutions S.L. (DyCare): lead
• Hospital Clinic of Barcelona: collaborator
• EASME: collaborator

Study Sites (1)

Hospital Clinic of Barcelona

Barcelona, 08036, Spain

Location

Related Publications (1)

• 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.

  PMID: 34013143 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

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

Study Officials

• Salvi Prat Fabregat

  Hospital Clinic of Barcelona

  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 4, 2019
• First Posted: November 7, 2019
• Study Start: November 25, 2019
• Primary Completion: December 3, 2020
• Study Completion: December 3, 2020
• Last Updated: June 9, 2021

Record last verified: 2021-06

Locations

ES (1)