Does Rehabilitation After Total Hip Or Knee Arthroplasty Work (DRAW2)

NCT04960241 | Completed

• 1 other identifier: Bornholms Regionskommune
• Study Type: interventional
• Target: 169
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rehabilitation; Telerehabilitation; Arthroplasty, Replacement, Hip; Arthroplasty, Replacement, Knee

Keywords

Rehabilitation; Telerehabilitation; No intervention; Total hip arthroplasty; Total knee arthroplasty

Outcome Measures

Primary Outcomes (1)

• Function in daily living (ADL).

  For THA's: Hip disability and Osteoarthritis Outcome Score (HOOS) subscale: function in daily living (ADL). For TKA's: Knee injury and Osteoarthritis Outcome Score (KOOS) subscale: function in daily living (ADL). This subscale consists of 17 questions related to the patient's function in activities of daily living such as "descending stairs", "standing" and "getting in/out of car". The subscale is scored by the degree of difficulty the patient experiences in the last week on a 5-point Likert scale (none, mild, moderate, severe, and extreme), and calculated to a score ranging from 0 (worst/extreme difficulties) to 100 (best/ no problems). The total questionnaire takes about 10 minutes to complete. At least 50% of the questionnaire items are required to be answered to permit calculation of a mean score.

  Difference between groups at first follow up (6 weeks)

Secondary Outcomes (9)

• Function in daily living (ADL)

  Difference between groups at 3 and 12 months follow up.

• Symptoms, pain and quality of life.

  Baseline, 6 weeks, 3 and 12 months.

• Patient global assessment

  Baseline, 6 weeks, 3 and 12 months.

• 30-s chair stand test.

  Baseline, follow up at 6 weeks, 3 and 12 months

• 40 meters walking test.

  Baseline, follow up at 6 weeks, 3 and 12 months

Other Outcomes (1)

• Homebased telerehabilitation + homebased rehabilitation group: Exercise adherence

  Follow up at 6 weeks

Study Arms (3)

Homebased telerehabilitation

ACTIVE COMPARATOR

Patients randomized to this group will receive interactive virtual rehabilitation using a mobile app. The telerehabilitation is based on sensor technology, developed by ICURA. This 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 patient with visual response. A unique feature of ICURA trainer allows the physiotherapist to remotely supervise the individual patients exercise adherence and progress. This technology has already been successfully implemented in several different rehabilitation facilities across Denmark, and, hence, reflects current clinical practice.

Procedure: Homebased telerehabilitation

Homebased rehabilitation

ACTIVE COMPARATOR

This group will be instructed in similar exercises as patients allocated to telerehabilitation. However, this group will receive a written exercise-program with instructions to perform these exercises at home. The home-based exercise program will be created using exercise templates from Exorlive. Using a link provided in the exercise-program, the patients will be able to see short instruction-videos of the individual exercises.

Procedure: Homebased rehabilitation

No physical rehabilitation

ACTIVE COMPARATOR

This group of randomised patients will not be given any physical rehabilitation intervention. This means no physical activity or exercise designed and prescribed for restoring normal function or reducing pain cause by disease, injury or surgery. The no intervention group will be encouraged to stay active and continue life as usual, gradually returning to their activities of daily living when they feel ready for it.

Procedure: No physical rehabilitation

Interventions

Homebased telerehabilitation PROCEDURE

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 telerehabilitation

Homebased rehabilitation PROCEDURE

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.

Homebased rehabilitation

No physical rehabilitation PROCEDURE

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.

No physical rehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients having had primary, unilateral THA or TKA due to osteoarthritis. Patients being referred to receive postoperative rehabilitation at our institution.
• Patients being able to speak, read and understand Danish language. Patients aged ≥ 18 years.

You may not qualify if:

• Patients not able to comply with exercise instructions. Patients who are discharged to a nursing-home facility or receiving in-home rehabilitation by home care.

Sponsors & Collaborators

• Troels Mark Christensen: lead

Study Sites (1)

Genoptræningen, Nørremøllecenteret

Nexø, Bornholm, 3730, Denmark

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: A physiotherapist will assess the outcomes at baseline after which the patients are randomized. The same physiotherapist will then deliver the allocated intervention and no longer assess outcomes for this patient. A different physiotherapist, who is blinded to treatment allocation, will assess outcomes at the follow-up visits in this patient. At all follow-up visits, patients will be asked not to disclose any information regarding group allocation, and the physiotherapists will be instructed not to ask questions regarding group allocation. The patients are blinded to the trial hypothesis in order to prevent ascertainment bias. The principal investigator is not an outcome assessor and will not be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Model Details: Homebased telerehabiltation. Homebased rehabilitation. No physical rehabilitation.

Study Record Dates

• First Submitted: July 2, 2021
• First Posted: July 13, 2021
• Study Start: April 6, 2021
• Primary Completion: March 22, 2024
• Study Completion: March 18, 2025
• Last Updated: October 6, 2025

Record last verified: 2024-10

Locations

DK (1)