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

Knee Osteoarthritis Clinical Trial

— REHAPT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04155957
• Other study ID #: DCEB28042019
• Status: Completed
• Phase: N/A
• Start date: November 25, 2019
• Est. completion date: December 3, 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 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: December 3, 2020
• Est. primary completion date: December 3, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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.

Locations

Country	Name	City	State
Spain	Hospital Clinic of Barcelona	Barcelona

Sponsors (3)

Lead Sponsor	Collaborator
Bio-Sensing Solutions S.L. (DyCare)	EASME, Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
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.	4 weeks after discharge
Secondary	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