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Evaluation of Safety and Efficacy of ReHub in Patients Who Underwent Primary TKA (REHAPT) (REHAPT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04155957
Recruitment Status : Recruiting
First Posted : November 7, 2019
Last Update Posted : December 2, 2019
Sponsor:
Collaborators:
Hospital Clinic of Barcelona
EASME
Information provided by (Responsible Party):
Bio-Sensing Solutions S.L. (DyCare)

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).


Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Other: Rapid Recovery Rehabilitation Programme Device: ReHub Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Safety and Efficacy of ReHub in Patients Who Underwent Primary TKA
Actual Study Start Date : November 25, 2019
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : April 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

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.





Primary Outcome Measures :
  1. Change in Active Knee Range of Motion (º) [ Time Frame: Baseline, 2 weeks and 4 weeks after discharge ]
    Range of motion of the replaced knee without the aid of the outcomes assessor will be measured with a conventional goniometer.

  2. Change in Passive Knee Range of Motion (º) [ Time Frame: Baseline, 2 weeks and 4 weeks after discharge ]
    Range of motion of the replaced knee with the aid of the outcomes assessor will be measured with a conventional goniometer.


Secondary Outcome Measures :
  1. Change in the Timed Up-and-Go test score (s) [ Time Frame: Baseline, 2 weeks and 4 weeks after discharge ]
    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.

  2. Change in Self-Reported Pain Level: Visual Analogue Scale [ Time Frame: Baseline, 2 weeks and 4 weeks after discharge ]
    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.

  3. Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score [ Time Frame: Baseline, 2 weeks and 4 weeks after discharge ]
    Scores for the WOMAC questionnaire range from 0 to 96, with 0 being the best state and 96 the worst state.

  4. Change in EuroQol-5D-5L (EQ-5D-5L) score [ Time Frame: Baseline, 2 weeks and 4 weeks after discharge ]
    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).

  5. Change in Quadriceps Strength (kg) [ Time Frame: Baseline, 2 weeks and 4 weeks after discharge ]
    Strength of the quadriceps in the intervened leg will be measured with a dynamometer.

  6. Change in Hamstring Strength (kg) [ Time Frame: Baseline, 2 weeks and 4 weeks after discharge ]
    Strength of the hamstring muscles in the intervened leg will be measured with a dynamometer.

  7. Satisfaction with ReHub: System Usability Scale [ Time Frame: 4 weeks after discharge ]
    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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04155957


Locations
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Spain
Hospital Clinic of Barcelona Recruiting
Barcelona, Spain, 08036
Contact: Salvi Prat Fabregat    +34932275533    sprat@clinic.cat   
Sponsors and Collaborators
Bio-Sensing Solutions S.L. (DyCare)
Hospital Clinic of Barcelona
EASME
Investigators
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Principal Investigator: Salvi Prat Fabregat Hospital Clinic of Barcelona
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Responsible Party: Bio-Sensing Solutions S.L. (DyCare)
ClinicalTrials.gov Identifier: NCT04155957    
Other Study ID Numbers: DCEB28042019
First Posted: November 7, 2019    Key Record Dates
Last Update Posted: December 2, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases