NCT03047252

Rehabilitation for Total Knee Replacement: a Novel Biofeedback System Versus Conventional Home-based Rehabilitation

Completed NA Last updated 6 February 2019

What this trial tests

NA trial testing Home-based rehabilitation with a digital biofeedback system in Knee Osteoarthritis in 69 participants. Completed in 27 May 2018.

Timeline

19 December 2016

Primary endpoint
27 May 2018

27 May 2018

Quick facts

Lead sponsor	Sword Health, SA
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	69
Start date	19 December 2016
Primary completion	27 May 2018
Estimated completion	27 May 2018
Sites	1 location across Portugal

Drugs / interventions tested

• Home-based rehabilitation with a digital biofeedback system
• Conventional Home-based rehabilitation

Conditions studied

• Knee Osteoarthritis — all drugs for Knee Osteoarthritis →
• Arthropathy of Knee — all drugs for Arthropathy of Knee →

Sponsor

Sword Health, SA

Who can join

18 and older, any sex, with Knee Osteoarthritis or Arthropathy of Knee. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The study was designed to test patient acceptance and system usability and to assess clinical outcomes of a home-based rehabilitation program using a novel kinematic biofeedback system in the rehabilitation after total knee replacement versus conventional rehabilitation, This system allows the patients to perform independent rehabilitation sessions at home, under remote monitoring from the clinical team.

The investigators hypothesize that the system will be well received by patients and that the clinical outcomes will be at least similar those of conventional rehabilitation.

This is a quasi-randomized controlled trial with active comparator. Patients will be enrolled pre-operatively and divided into 2 groups: experimental group and conventional rehabilitation group according to geographical criteria. Both groups will perform 8 weeks of rehabilitation starting between day 7 and 10 after surgery.

The experimental group will perform daily rehabilitation sessions at home using the system, under remote monitoring from a physical therapist. The conventional rehabilitation group will perform 1h rehabilitation sessions 3 times a week, at home, given by a physical therapist.

The following feasibility outcomes will be registered: enrollment rate, retention rate (drop-outs), compliance to the program, independence of use, need for therapist contact and patient satisfaction.

Clinical outcomes will be measured at weeks 4 and 8 and then at 3 and 6 months. The primary outcome will be measured in terms of patient performance in the Timed-up-and-Go (TUG) test in comparison with the pre-operative score. Secondary outcomes will be measured in terms of: b) Knee Osteoarthritis Outcome Score); c) range of motion of the knee joint.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Home-based Rehabilitation With A Novel Digital Biofeedback System versus Conventional In-person Rehabilitation after Total Knee Replacement: a feasibility study.
   Correia FD, Nogueira A, Magalhães I, Guimarães J, et al · · 2018 · cited 67× · PMID 30050087 · DOI 10.1038/s41598-018-29668-0
2. Medium-Term Outcomes of Digital Versus Conventional Home-Based Rehabilitation After Total Knee Arthroplasty: Prospective, Parallel-Group Feasibility Study.
   Correia FD, Nogueira A, Magalhães I, Guimarães J, et al · · 2019 · cited 57× · PMID 30816849 · DOI 10.2196/13111
3. Digital Versus Conventional Rehabilitation After Total Hip Arthroplasty: A Single-Center, Parallel-Group Pilot Study.
   Dias Correia F, Nogueira A, Magalhães I, Guimarães J, et al · · 2019 · cited 40× · PMID 31228176 · DOI 10.2196/14523