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Does Rehabilitation After Total Hip Or Knee Arthroplasty Work (DRAW2)
Sponsor: Troels Mark Christensen
Summary
Overall frame: The overall or "parent" DRAW-project is a large-scale project run in Denmark that aims to provide substantial level 1A evidence-data related to the question: Does rehabilitation after total hip and knee replacements work? In the DRAW project, the authors challenge the belief that physical rehabilitation is clinically important - and surely better than "no physical rehabilitation". To challenge this belief thoroughly, the DRAW project holds many individual work packages centered around the same question. These work packages will be conducted in collaboration with municipality rehabilitation centers in Denmark so that specific usual care strategies are reflected in the different trials and local clinical relevance is as well as implementation potential are increased. Explanatory statement: Because the DRAW2 trial was conceived as a direct methodological replication of DRAW1, early administrative procedures mistakenly linked the new cohort to the existing DRAW1 registration (NCT03750448). This was an internal administrative misunderstanding rather than an attempt to obscure trial conduct or outcomes. Following guidance from the Regional Ethics Committee, it became clear that DRAW2 should be registered as an independent study to ensure transparent reporting of its distinct protocol, sample, and analyses. Consequently, a separate ClinicalTrials.gov entry was created once this requirement was identified. We like to document the administrative origin of the discrepancy while confirming that it had no impact on blinding, allocation concealment, or the scientific integrity of the trial.
Official title: Physical Rehabilitation Versus no Physical Rehabilitation After Total Hip and Knee Arthroplasties: Protocol for a Pragmatic, Randomized, Controlled, Replication Trial (DRAW2)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
169
Start Date
2021-04-06
Completion Date
2025-03-18
Last Updated
2026-10-08
Healthy Volunteers
No
Conditions
Interventions
Homebased telerehabilitation
The telerehabilitation intervention is based on sensor technology, developed by ICURA. The technology consists of motion sensors that can measure and analyse the quantity and quality of the exercises, and a mobile application that can guide the patients with visual response. A unique feature of ICURA trainer allows the physiotherapist to remotely supervise the individual patients exercise adherence and progress. The patients will receive a suitcase with five sensors (to be placed bilaterally on lower legs, thighs and one around the waist), a smartphone to record the exercises and a charging station free of charge during the 6-week intervention. At the end of the intervention the material will be returned at the first follow-up (t1). For more information please visit https://icura.dk.
Homebased rehabilitation
The unsupervised rehabilitation group will receive a written exercise program in order to perform daily exercises at home. The exercise program will be made using Exorlive (for more information about Exorlive please visit https://www.exorlive.com). In addition to the written program, patients will able to use a link provided to see small video-instructions on the internet of each exercise on the program. No feedback or supplementary instructions will be given after the initial face-to-face appointment.
No physical rehabilitation
Patients allocated to the no intervention group will receive encouragement to stay active and be encouraged to gradually return to activities of daily living. This will be the only exercise-encouragement given to the no-intervention group.
Locations (1)
Genoptræningen, Nørremøllecenteret
Nexø, Bornholm, Denmark