RehabilitationDRAW2NCT04960241
Does Rehabilitation After Total Hip Or Knee Arthroplasty Work (DRAW2)
A study testing Homebased telerehabilitation, Homebased rehabilitation and No physical rehabilitation in people with Rehabilitation and Telerehabilitation, run by Troels Mark Christensen at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rehabilitation, Telerehabilitation, Arthroplasty, Replacement, Hip
- What is being tested?
- Homebased telerehabilitation, Homebased rehabilitation and No physical rehabilitation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 169 participants
- Where
- 1 siteDenmark
- Study dates
- 6 Apr 2021to 18 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physical Rehabilitation Versus no Physical Rehabilitation After Total Hip and Knee Arthroplasties: Protocol for a Pragmatic, Randomized, Controlled, Replication Trial (DRAW2)
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:
Read more
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.
Read the detailed description
The DRAW2-trial is a pragmatic, randomised controlled trial that aims to replicate the DRAW1-trial findings (clinicaltrials.gov: NCT03750448, trial protocol: https://f1000research.com/articles/10-146). Based on stakeholder input from Municipality Rehabilitation Bornholm, the DRAW1-trial was designed as a superiority trial to test the hypothesis that physical rehabilitation (telerehabilitation and home-based rehabilitation) is superior to no physical rehabilitation in a mixed population of patients after total hip and knee arthroplasty (THA and TKA, respectively). After DRAW1-trial inclusion was completed and the target sample size reached, an opportunity to continue the trial presented because additional funding was obtained. At the same time, Municipality Rehabilitation Bornholm asked for stratified data (THA/TKA) that could help guide their decision concerning a potential purchase of telerehabilitation equipment (more details on stakeholder input can be found in the trial protocol, https://f1000research.com/articles/10-146). To meet this new research objective of stratified analysis for THA and TKA, it was advised from the local ethical committee that a new and almost identical trial was registered, which would allow for a doubling of the sample simple size, so that adequately powered stratified analyses could be made. This new trial is named the DRAW2-trial.
The DRAW2-trial will adhere to the published DRAW1-trial protocol (https://f1000research.com/articles/10-146) and only small logistic modifications to trial procedures have been made. Because some of the DRAW1-trial participants felt overwhelmed by the amount of information they received during the first and only study introduction (usually takes place 5-7 days after surgery), the study introduction in the DRAW2-trial can be divided into two separate consultations a few days apart whenever deemed appropriate by the consulting physiotherapist. The DRAW2 trial will be reported and published independently, including the same outcomes and outcome hierarchy as the DRAW1-trial. As such, it will be an independent replication trial.
Research plan
While the DRAW2-trial will focus on replication of the DRAW-1 trial findings, the opportunity to run a replication trial at the same trial site with little delay between the two trials will also enable us to address the questions outlined below, by subsequent pooling of data from the two trials.
Question 1: Is physical rehabilitation superior to no physical rehabilitation after THA and TKA using two usual care strategies in Denmark (stratified analyses THA vs. TKA by pooling DRAW1 and 2 trial data)?
Question 2: Is home-based rehabilitation as good as home-based telerehabilitation in a mixed population of THA and TKA using two usual care strategies in Denmark (equivalence analysis by pooling DRAW1 and 2 trial data)?
Question 3: Is physical rehabilitation superior to no physical rehabilitation after THA in general (using DRAW1 and 2 THA trial data in an ongoing living systematic review? (https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=203574).
Question 3: Is physical rehabilitation superior to no physical rehabilitation after TKA in general (using DRAW1 and 2 TKA trial data in an ongoing living systematic review? (https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42018094785).
- Conditions
- Rehabilitation, Telerehabilitation, Arthroplasty, Replacement, Hip, Arthroplasty, Replacement, Knee
- Being tested
- Homebased telerehabilitation, Homebased rehabilitation, No physical rehabilitation
- Keywords
- Rehabilitation, Telerehabilitation, No intervention, Total hip arthroplasty, Total knee arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Homebased telerehabilitationProcedure or surgery
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 rehabilitationProcedure or surgery
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 rehabilitationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Procedure: No physical rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Difference between groups at first follow up (6 weeks)
Secondary outcomes (9)
Function in daily living (ADL)
See above
Measured: Difference between groups at 3 and 12 months follow up.
Symptoms, pain and quality of life.
For THA: 3 subscales in the patient-rapported questionnaire "HOOS" For TKA: 3 subscales in the patient-rapported questionnaire "KOOS".
These subscales are scored by the degree of difficulty the patient has experienced in the last week on a 5-point Likert scale. Each subscale provides a score, which can be calculated to a total score ranging from 0 (worst/extreme difficulties) to 100 (best/ no problems). At least 50% of the questionnaire items in each subscale are required to be answered to permit calculation of a mean score.
Measured: Baseline, 6 weeks, 3 and 12 months.
Patient global assessment
At baseline the patient's perception of his or her overall functional ability will be assessed using a single numeric rating scale, as recommended by OARSI. The patient will be asked a single question: "How would you rate your current level of function during your usual activities of daily living?" During follow-up assessment patients will be asked the same question as at baseline. Their answer will be rated on a 0-100 visual rating scale with end-points anchored as "Inability to perform any daily activities" (0) and "No problem with any daily activity" (100)
Measured: Baseline, 6 weeks, 3 and 12 months.
30-s chair stand test.
Performance-based assessment will be performed using the 30-s chair-stand test, which represent the sit-to-stand activity. The test counts the number of sit-to-stand repetitions the patient can perform in 30 seconds. The straight-back chairs used for testing during all outcome assessments will be of the same model, same height (approximately 43 cm), and will be placed against a wall. Any other adaptations (i.e. the use of armrests or assistive devices) will be reported. To assure understanding, two slow-paced repetitions will be practiced before the test initiates. The 30-s chair stand test has proven good reliability to measure functional performance following THA and TKA.
Measured: Baseline, follow up at 6 weeks, 3 and 12 months
40 meters walking test.
This performance-based assessment measures short distance walking activity. The patient will be instructed to walk as quickly as safely as possible to a mark 10 meters away, return and repeat for a total distance of 40 meters. Each walk of 10 meters (excluding the turn time) is recorded and expressed as speed m/s by dividing distance by time in seconds. A practice walk up and back will be performed to assure understanding. Any assistive devices used will be recorded.
Measured: Baseline, follow up at 6 weeks, 3 and 12 months
Use of analgesics
The use of analgesics will recorded at baseline and at all follow-up assessments, using a nominal scale (yes/no) regarding the daily consumption of opioids, non-steroid-anti inflammatorily drug (NSAID) and paracetamol. If the patient were not aware of his or hers use of analgesics, a medical record will obtained to assess the use of analgesics.
Measured: Baseline, follow up at 6 weeks, 3 and 12 months.
Patient satisfaction
Patients will be asked to answer four questions to indicate their level of satisfaction. The answers will be based on a 4-Likert ordinal scale with the categories: very satisfied (100 points), somewhat satisfied (75 points), somewhat dissatisfied (50 points), and very dissatisfied (25 points). The score is the unweighted mean of the combined scores. The four questions are: "How satisfied are you with the results of your surgery and rehabilitation?", "How satisfied are you with your surgery and rehabilitation for improving your pain?", "How satisfied are you with the results of your surgery and rehabilitation for improving your ability to do home or yard work?" and "How satisfied are you with the results of surgery and rehabilitation for improving your ability to do recreational activities?". The questions are modified from the Self-Administered Patient Satisfaction Scale for Primary Hip and Knee Arthroplasty.
Measured: Follow up at 6 weeks.
Time usage (care provider).
Analysis of the economical resources required for each of the three rehabilitation strategies. The principal investigator intend to use this data in a later cost-analysis.
Measured: Baseline, follow up at 6 weeks, 3 and 12 months
Number of adverse events
Number and nature of adverse events during enrolment of the trial will be recorded, regardless of the relation to the trial.
Measured: Baseline, follow up at 6 weeks, 3 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2021
- Study start6 Apr 2021
- Primary completion22 Mar 2024
- Study completion18 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for RehabilitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Homebased telerehabiltation. Homebased rehabilitation. No physical rehabilitation.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 169 participants (actual)
Sponsor and investigators
- Lead sponsor
- Troels Mark Christensen
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Troels Mark Christensen, Bornholms Regionskommune
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04960241
- Sponsor's protocol ID
- Bornholms Regionskommune
- Acronym
- DRAW2
- Status last verified
- Oct 2026
- First submitted
- 2 Jul 2021
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mark-Christensen T, Thorborg K, Kallemose T, Bandholm T. A randomized replication trial of physical rehabilitation versus no physical rehabilitation (DRAW2). Sci Rep. 2026 Jun 10. doi: 10.1038/s41598-026-56195-0. Online ahead of print.
PubMed 42270698
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Rehabilitation Versus no Physical Rehabilitation After Total Hip and Knee Arthroplasties: Protocol for a Pragmatic, Randomized, Controlled, Replication Trial (DRAW2)
- ClinicalTrials.gov ID
- NCT04960241
- Acronym / sponsor ID
- DRAW2 / Bornholms Regionskommune
- Conditions
- Rehabilitation, Telerehabilitation, Arthroplasty, Replacement, Hip, Arthroplasty, Replacement, Knee
- Keywords
- Rehabilitation, Telerehabilitation, No intervention, Total hip arthroplasty, Total knee arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 169 participants (actual)
- Lead sponsor
- Troels Mark ChristensenOther government
- Study start
- 6 Apr 2021 (actual)
- Primary completion
- 22 Mar 2024 (actual)
- Study completion
- 18 Mar 2025 (actual)
- First posted
- 13 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The DRAW2-trial is a pragmatic, randomised controlled trial that aims to replicate the DRAW1-trial findings (clinicaltrials.gov: NCT03750448, trial protocol: https://f1000research.com/articles/10-146). Based on stakeholder input from Municipality Rehabilitation Bornholm, the DRAW1-trial was designed as a superiority trial to test the hypothesis that physical rehabilitation (telerehabilitation and home-based rehabilitation) is superior to no physical rehabilitation in a mixed population of patients after total hip and knee arthroplasty (THA and TKA, respectively). After DRAW1-trial inclusion was completed and the target sample size reached, an opportunity to continue the trial presented because additional funding was obtained. At the same time, Municipality Rehabilitation Bornholm asked for stratified data (THA/TKA) that could help guide their decision concerning a potential purchase of telerehabilitation equipment (more details on stakeholder input can be found in the trial protocol, https://f1000research.com/articles/10-146). To meet this new research objective of stratified analysis for THA and TKA, it was advised from the local ethical committee that a new and almost identical trial was registered, which would allow for a doubling of the sample simple size, so that adequately powered stratified analyses could be made. This new trial is named the DRAW2-trial.
The DRAW2-trial will adhere to the published DRAW1-trial protocol (https://f1000research.com/articles/10-146) and only small logistic modifications to trial procedures have been made. Because some of the DRAW1-trial participants felt overwhelmed by the amount of information they received during the first and only study introduction (usually takes place 5-7 days after surgery), the study introduction in the DRAW2-trial can be divided into two separate consultations a few days apart whenever deemed appropriate by the consulting physiotherapist. The DRAW2 trial will be reported and published independently, including the same outcomes and outcome hierarchy as the DRAW1-trial. As such, it will be an independent replication trial.
Research plan
While the DRAW2-trial will focus on replication of the DRAW-1 trial findings, the opportunity to run a replication trial at the same trial site with little delay between the two trials will also enable us to address the questions outlined below, by subsequent pooling of data from the two trials.
Question 1: Is physical rehabilitation superior to no physical rehabilitation after THA and TKA using two usual care strategies in Denmark (stratified analyses THA vs. TKA by pooling DRAW1 and 2 trial data)?
Question 2: Is home-based rehabilitation as good as home-based telerehabilitation in a mixed population of THA and TKA using two usual care strategies in Denmark (equivalence analysis by pooling DRAW1 and 2 trial data)?
Question 3: Is physical rehabilitation superior to no physical rehabilitation after THA in general (using DRAW1 and 2 THA trial data in an ongoing living systematic review? (https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=203574).
Question 3: Is physical rehabilitation superior to no physical rehabilitation after TKA in general (using DRAW1 and 2 TKA trial data in an ongoing living systematic review? (https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42018094785).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- Homebased telerehabiltation. Homebased rehabilitation. No physical rehabilitation.
| Arm | Type | Receives |
|---|---|---|
| Homebased telerehabilitation | Active comparator | Procedure: Homebased telerehabilitationPatients 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. |
| Homebased rehabilitation | Active comparator | Procedure: Homebased rehabilitationThis 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. |
| No physical rehabilitation | Active comparator | Procedure: No physical rehabilitationThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Homebased telerehabilitationThe 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. | Procedure or surgery | Homebased telerehabilitation |
| Homebased rehabilitationThe 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. | Procedure or surgery | Homebased rehabilitation |
| No physical rehabilitationPatients 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. | Procedure or surgery | No physical rehabilitation |
Primary outcome
Function in daily living (ADL).
Time frame: Difference between groups at first follow up (6 weeks)
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.
9 secondary outcomes
Function in daily living (ADL)
Time frame: Difference between groups at 3 and 12 months follow up.
Symptoms, pain and quality of life.
Time frame: Baseline, 6 weeks, 3 and 12 months.
Patient global assessment
Time frame: Baseline, 6 weeks, 3 and 12 months.
30-s chair stand test.
Time frame: Baseline, follow up at 6 weeks, 3 and 12 months
40 meters walking test.
Time frame: Baseline, follow up at 6 weeks, 3 and 12 months
Use of analgesics
Time frame: Baseline, follow up at 6 weeks, 3 and 12 months.
Patient satisfaction
Time frame: Follow up at 6 weeks.
Time usage (care provider).
Time frame: Baseline, follow up at 6 weeks, 3 and 12 months
Number of adverse events
Time frame: Baseline, follow up at 6 weeks, 3 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Derived from this study: PubMed 42270698Mark-Christensen T, Thorborg K, Kallemose T, Bandholm T. A randomized replication trial of physical rehabilitation versus no physical rehabilitation (DRAW2). Sci Rep. 2026 Jun 10. doi: 10.1038/s41598-026-56195-0. Online ahead of print.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Homebased telerehabilitation, Homebased rehabilitation and No physical rehabilitation in people with Rehabilitation and Telerehabilitation, run by Troels Mark Christensen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Function in daily living (ADL). (time frame: Difference between groups at first follow up (6 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04960241, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.