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NCT04155957 | COMPLETED | Knee Osteoarthritis


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

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

Knee Osteoarthritis

Intervention/treatment

Rapid Recovery Rehabilitation Programme

ReHub

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 52 participants
Masking : SINGLE
Primary Purpose : TREATMENT
Official Title : Evaluation of Safety and Efficacy of ReHub in Patients Who Underwent Primary Total Knee Arthroplasty
Actual Study Start Date : 2019-11-25
Estimated Primary Completion Date : 2020-12-03
Estimated Study Completion Date : 2020-12-03

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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)

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

Location Details

NCT04155957


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Locations


Not yet recruiting

Spain,

Hospital Clinic of Barcelona

Barcelona, Spain, 08036

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