StrokeREUSENCT03522519
Predicting Real World Physical Activity and Upper Limb Use After Stroke
An observational study of Stroke, run by University of Zurich at 1 site in Switzerland.
Trial summary
Poststroke recovery mainly takes place within the first weeks to months and about 95% of the patients reach their maximum recovery 3 months after stroke onset. Poststroke rehabilitation is initiated as early as possible and aims to reduce functional consequences of stroke, allowing patients to integrate into the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Real world performance of physical activity and arm use
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 98 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Sep 2018to 31 Mar 2021
- Phase
- Observational
- 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
Study population: Admitted to hospital
Who may be able to join
- First-ever ischemic or hemorrhagic stroke, confirmed by MRI-DWI and/or CT (recurrent strokes are allowed when already included in this study after a first-ever stroke)
- Paresis or paralysis of the arm and/ or leg
- Living independently before stroke (mRS >2)
- Age 18 years or older
- Written informed consent of the patient or its legal representative after participants' information
Who cannot join
- Contra-indications on ethical grounds (vulnerable persons)
- Neurological or other diseases affecting upper limb use and/ or physical activity before stroke
- Known or suspected non-compliance, drug or alcohol abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Profiling and Predicting the Natural Course of Real World Physical Activity and Upper Limb Use After Stroke
Poststroke recovery mainly takes place within the first weeks to months and about 95% of the patients reach their maximum recovery 3 months after stroke onset. Poststroke rehabilitation is initiated as early as possible and aims to reduce functional consequences of stroke, allowing patients to integrate into the community. However, up to 75% of the patients remain disabled in the long term. Strikingly, about 20 to 30% of the patients show functional decline (i.e., learned-nonuse) in the long term - most often after having finished their intensive rehabilitation period - and even stroke survivors who have little or no residual disability are less physically active when compared to their age-matched peers.
Poststroke outcomes can be well predicted early after stroke. However, the deficits early after stroke and the outcomes are measured by standardized clinical tests performed in the laboratory. The drawback of these tests is that they provide information about the best possible abilities of the patients, as they are encouraged by therapists in testing situations. This so called "capacity" does not necessarily reflect what patients do in daily life situations (i.e., "performance" or "real world use").
Read more
With the growing interest in the patients' performance, various assessments that objectively measure activities in daily life situations have been developed in the last few years. These devices capture movement in daily life situations in a sensitive and objective way. An additional benefit is that they are less hampered by floor or ceiling effects when compared to clinical laboratory measurements (i.e., clinimetrics). Nevertheless, outcome of real world performance is hardly ever used in clinical trials aiming to determine the effectiveness of stroke rehabilitation interventions. Actually, until today, the natural course of performance remains largely unknown, as are predictors for this course. It is also unknown to which extend patients' subjective reporting of performance matches objectively measured performance. Finally, although it is believed that there is a threshold for, for example, real life use of the paretic arm and further improvement, there is no evidence as to what this threshold is in terms of clinical laboratory measurements.
The present prospective longitudinal cohort study fills in the gap regarding knowledge about the profile and predictability of two performance outcomes during the first year poststroke: engagement in physical activities and the use of the paretic upper limb. In addition, it will provide insight in how physical activity engagement and upper limb use measured by daily life assessments relate to standard clinical laboratory assessments. This knowledge is a prerequisite for the identification of patients' phenotypes and a first essential step towards the development of tailored (i.e., precision medicine), innovative rehabilitation interventions which enhance performance in terms of physical activities or upper limb use in daily life. The ultimate goal is to reduce poststroke disability and associated costs.
RE-USE is a prospective longitudinal observational cohort study of 120 first-ever stroke patients, who will be assessed 3, 10, 28, 90 and 365 days after stroke onset, as well as at discharge of the rehabilitation center.
- Conditions
- Stroke
- Being tested
- Real world performance of physical activity and arm use
- Keywords
- Physical Activity, Upper Extremity, Movement Sensors, Prognosis, Observational Cohort Study
- Medical subject headings
- Stroke, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real world performance of physical activity and arm useBehavioural
Patients will be assessed by using movement sensors and standard clinical assessments
| Study group | Role | What they receive |
|---|---|---|
| Assessment of real world performance | Not described Receives: Behavioral: Real world performance of physical activity and arm use |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily life assessment of physical activity engagement and upper limb use
Real world performance, measured with movement sensors (number)
Measured: 90 days after stroke onset
Secondary outcomes (21)
Neurological impairments
National Institutes of Health Stroke Scale (0-42 points, lower scores being better)
Measured: 3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Upper limb motor function
Fugl-Meyer Assessment (0-66 points, higher scores being better)
Measured: 3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Motor function
Motricity Index (0-200 points, higher scores being better)
Measured: 3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Trunk ability
Trunk Control Test (0-100 points, higher scores being better)
Measured: 3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Sitting and standing balance
Berg Balance Scale (0-56 points, higher scores being better)
Measured: 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Walking ability (independence)
Functional Ambulation Categories (0-5 points, higher scores being better)
Measured: 3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Gait speed and cadence (time)
Ten-Meter Walk Test
Measured: 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Upper limb capacity
Action Research Arm Test (0-56 points, higher scores being better)
Measured: 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Upper limb capacity dexterity
Box and Block Test (number of blocks)
Measured: 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Global disability
Modified Rankin Scale (0-6 points, lower scores being better)
Measured: 3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Fatigue
Fatigue Severity Scale (9-63 point, lower scores being better)
Measured: 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Cognition
Montreal Cognitive Assessment(0-30 points, higher scores being better)
Measured: 3 and 90 days after stroke onset
Neglect
Apples Test (number)
Measured: 3 and 90 days after stroke onset
Patient-reported physical activity
International Physical Activity Questionnaire (3 levels higher levels are better)
Measured: 90 and 365 days after stroke onset
Patient-reported daily life upper limb use
Motor Activity Log - 14 item version (0-5 points, higher scores being better)
Measured: 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Patient-reported changes
Global Rating of Perceived Changes (1-7 points, higher scores being better; 1-10 points, lower scores being better)
Measured: 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Concomitant movement therapy
Intensity of therapy based on charts (minutes)
Measured: 3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Serious Events and non-serious infections or cardiovascular events
Serious Events (1. death; 2. life-threatening illness or injury; 3. in-patient or prolonged hospitalisation; 4. medical or surgical intervention to prevent life threatening illness; 5. led to fetal distress, death or a congenital abnormality or birth defect) and non-serious infections or cardiovascular events
Measured: 3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Daily life assessment of physical activity engagement and upper limb use
Real world performance, measured with movement sensors (number)
Measured: 3, 10, 28 (expected rehabilitation discharge) and 365 days after stroke onset
Levels of anxiety and depression
Hospital Anxiety and Depression Scale (0-42 points, higher scores indicate greater levels of anxiety or depression)
Measured: 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Health care costs and loss of income
Health care costs and loss of income in relation to the stroke (CHF)
Measured: 365 days after stroke onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2018
- Study start1 Sep 2018
- Primary completion31 Mar 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andreas R Luft, Prof. Dr., Study chair, University of Zurich, University Hospital Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03522519
- Sponsor's protocol ID
- 2017-01070
- Other IDs
- 2017
- Acronym
- REUSE
- Status last verified
- Nov 2021
- First submitted
- 16 Apr 2018
- Last updated
- 29 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bailey RR, Klaesner JW, Lang CE. Quantifying Real-World Upper-Limb Activity in Nondisabled Adults and Adults With Chronic Stroke. Neurorehabil Neural Repair. 2015 Nov-Dec;29(10):969-78. doi: 10.1177/1545968315583720. Epub 2015 Apr 20.
PubMed 25896988Han CE, Arbib MA, Schweighofer N. Stroke rehabilitation reaches a threshold. PLoS Comput Biol. 2008 Aug 22;4(8):e1000133. doi: 10.1371/journal.pcbi.1000133.
PubMed 18769588Jorgensen HS, Nakayama H, Raaschou HO, Vive-Larsen J, Stoier M, Olsen TS. Outcome and time course of recovery in stroke. Part II: Time course of recovery. The Copenhagen Stroke Study. Arch Phys Med Rehabil. 1995 May;76(5):406-12. doi: 10.1016/s0003-9993(95)80568-0.
PubMed 7741609Kwakkel G, Veerbeek JM, van Wegen EE, Wolf SL. Constraint-induced movement therapy after stroke. Lancet Neurol. 2015 Feb;14(2):224-34. doi: 10.1016/S1474-4422(14)70160-7.
PubMed 25772900Langhorne P, Bernhardt J, Kwakkel G. Stroke rehabilitation. Lancet. 2011 May 14;377(9778):1693-702. doi: 10.1016/S0140-6736(11)60325-5.
PubMed 21571152Miller EL, Murray L, Richards L, Zorowitz RD, Bakas T, Clark P, Billinger SA; American Heart Association Council on Cardiovascular Nursing and the Stroke Council. Comprehensive overview of nursing and interdisciplinary rehabilitation care of the stroke patient: a scientific statement from the American Heart Association. Stroke. 2010 Oct;41(10):2402-48. doi: 10.1161/STR.0b013e3181e7512b. Epub 2010 Sep 2. No abstract available.
PubMed 20813995Stewart JC, Cramer SC. Patient-reported measures provide unique insights into motor function after stroke. Stroke. 2013 Apr;44(4):1111-6. doi: 10.1161/STROKEAHA.111.674671. Epub 2013 Feb 19.
PubMed 23422082Stinear CM, Byblow WD. Letter by Stinear and Byblow regarding article, "patient-reported measures provide unique insights into motor function after stroke". Stroke. 2013 Jul;44(7):e79. doi: 10.1161/STROKEAHA.113.001689. Epub 2013 Jun 4. No abstract available.
PubMed 23735958Taub E, Uswatte G, Mark VW, Morris DM. The learned nonuse phenomenon: implications for rehabilitation. Eura Medicophys. 2006 Sep;42(3):241-56.
PubMed 17039223Wolfe CD, Crichton SL, Heuschmann PU, McKevitt CJ, Toschke AM, Grieve AP, Rudd AG. Estimates of outcomes up to ten years after stroke: analysis from the prospective South London Stroke Register. PLoS Med. 2011 May;8(5):e1001033. doi: 10.1371/journal.pmed.1001033. Epub 2011 May 17.
PubMed 21610863Noorkoiv M, Rodgers H, Price CI. Accelerometer measurement of upper extremity movement after stroke: a systematic review of clinical studies. J Neuroeng Rehabil. 2014 Oct 9;11:144. doi: 10.1186/1743-0003-11-144.
PubMed 25297823Veerbeek JM, van Wegen E, van Peppen R, van der Wees PJ, Hendriks E, Rietberg M, Kwakkel G. What is the evidence for physical therapy poststroke? A systematic review and meta-analysis. PLoS One. 2014 Feb 4;9(2):e87987. doi: 10.1371/journal.pone.0087987. eCollection 2014.
PubMed 24505342Pohl J, Verheyden G, Held JPO, Luft AR, Easthope Awai C, Veerbeek JM. Construct validity and responsiveness of clinical upper limb measures and sensor-based arm use within the first year after stroke: a longitudinal cohort study. J Neuroeng Rehabil. 2025 Jan 29;22(1):14. doi: 10.1186/s12984-024-01512-9.
PubMed 39881332
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Profiling and Predicting the Natural Course of Real World Physical Activity and Upper Limb Use After Stroke
- ClinicalTrials.gov ID
- NCT03522519
- Acronym / sponsor ID
- REUSE / 2017-01070
- Conditions
- Stroke
- Keywords
- Physical Activity, Upper Extremity, Movement Sensors, Prognosis, Observational Cohort Study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 11 May 2018 (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.
Poststroke recovery mainly takes place within the first weeks to months and about 95% of the patients reach their maximum recovery 3 months after stroke onset. Poststroke rehabilitation is initiated as early as possible and aims to reduce functional consequences of stroke, allowing patients to integrate into the community. However, up to 75% of the patients remain disabled in the long term. Strikingly, about 20 to 30% of the patients show functional decline (i.e., learned-nonuse) in the long term - most often after having finished their intensive rehabilitation period - and even stroke survivors who have little or no residual disability are less physically active when compared to their age-matched peers.
Poststroke outcomes can be well predicted early after stroke. However, the deficits early after stroke and the outcomes are measured by standardized clinical tests performed in the laboratory. The drawback of these tests is that they provide information about the best possible abilities of the patients, as they are encouraged by therapists in testing situations. This so called "capacity" does not necessarily reflect what patients do in daily life situations (i.e., "performance" or "real world use").
With the growing interest in the patients' performance, various assessments that objectively measure activities in daily life situations have been developed in the last few years. These devices capture movement in daily life situations in a sensitive and objective way. An additional benefit is that they are less hampered by floor or ceiling effects when compared to clinical laboratory measurements (i.e., clinimetrics). Nevertheless, outcome of real world performance is hardly ever used in clinical trials aiming to determine the effectiveness of stroke rehabilitation interventions. Actually, until today, the natural course of performance remains largely unknown, as are predictors for this course. It is also unknown to which extend patients' subjective reporting of performance matches objectively measured performance. Finally, although it is believed that there is a threshold for, for example, real life use of the paretic arm and further improvement, there is no evidence as to what this threshold is in terms of clinical laboratory measurements.
The present prospective longitudinal cohort study fills in the gap regarding knowledge about the profile and predictability of two performance outcomes during the first year poststroke: engagement in physical activities and the use of the paretic upper limb. In addition, it will provide insight in how physical activity engagement and upper limb use measured by daily life assessments relate to standard clinical laboratory assessments. This knowledge is a prerequisite for the identification of patients' phenotypes and a first essential step towards the development of tailored (i.e., precision medicine), innovative rehabilitation interventions which enhance performance in terms of physical activities or upper limb use in daily life. The ultimate goal is to reduce poststroke disability and associated costs.
RE-USE is a prospective longitudinal observational cohort study of 120 first-ever stroke patients, who will be assessed 3, 10, 28, 90 and 365 days after stroke onset, as well as at discharge of the rehabilitation center.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Assessment of real world performance | – | Behavioral: Real world performance of physical activity and arm use |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Admitted to hospital
Key inclusion criteria (5 listed)
- First-ever ischemic or hemorrhagic stroke, confirmed by MRI-DWI and/or CT (recurrent strokes are allowed when already included in this study after a first-ever stroke)
- Paresis or paralysis of the arm and/ or leg
- Living independently before stroke (mRS >2)
- Age 18 years or older
- Written informed consent of the patient or its legal representative after participants' information
Key exclusion criteria (3 listed)
- Contra-indications on ethical grounds (vulnerable persons)
- Neurological or other diseases affecting upper limb use and/ or physical activity before stroke
- Known or suspected non-compliance, drug or alcohol abuse
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 |
|---|---|---|
| Real world performance of physical activity and arm usePatients will be assessed by using movement sensors and standard clinical assessments | Behavioural | Assessment of real world performance |
Primary outcome
Daily life assessment of physical activity engagement and upper limb use
Time frame: 90 days after stroke onset
Real world performance, measured with movement sensors (number)
21 secondary outcomes
Neurological impairments
Time frame: 3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Upper limb motor function
Time frame: 3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Motor function
Time frame: 3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Trunk ability
Time frame: 3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Sitting and standing balance
Time frame: 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Walking ability (independence)
Time frame: 3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Gait speed and cadence (time)
Time frame: 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Upper limb capacity
Time frame: 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Upper limb capacity dexterity
Time frame: 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Global disability
Time frame: 3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Fatigue
Time frame: 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Cognition
Time frame: 3 and 90 days after stroke onset
Neglect
Time frame: 3 and 90 days after stroke onset
Patient-reported physical activity
Time frame: 90 and 365 days after stroke onset
Patient-reported daily life upper limb use
Time frame: 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Patient-reported changes
Time frame: 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Concomitant movement therapy
Time frame: 3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Serious Events and non-serious infections or cardiovascular events
Time frame: 3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Daily life assessment of physical activity engagement and upper limb use
Time frame: 3, 10, 28 (expected rehabilitation discharge) and 365 days after stroke onset
Levels of anxiety and depression
Time frame: 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Health care costs and loss of income
Time frame: 365 days after stroke onset
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 29 Nov 2021.
- Background: PubMed 25896988Bailey RR, Klaesner JW, Lang CE. Quantifying Real-World Upper-Limb Activity in Nondisabled Adults and Adults With Chronic Stroke. Neurorehabil Neural Repair. 2015 Nov-Dec;29(10):969-78. doi: 10.1177/1545968315583720. Epub 2015 Apr 20.
- Background: PubMed 18769588Han CE, Arbib MA, Schweighofer N. Stroke rehabilitation reaches a threshold. PLoS Comput Biol. 2008 Aug 22;4(8):e1000133. doi: 10.1371/journal.pcbi.1000133.
- Background: PubMed 7741609Jorgensen HS, Nakayama H, Raaschou HO, Vive-Larsen J, Stoier M, Olsen TS. Outcome and time course of recovery in stroke. Part II: Time course of recovery. The Copenhagen Stroke Study. Arch Phys Med Rehabil. 1995 May;76(5):406-12. doi: 10.1016/s0003-9993(95)80568-0.
- Background: PubMed 25772900Kwakkel G, Veerbeek JM, van Wegen EE, Wolf SL. Constraint-induced movement therapy after stroke. Lancet Neurol. 2015 Feb;14(2):224-34. doi: 10.1016/S1474-4422(14)70160-7.
- Background: PubMed 21571152Langhorne P, Bernhardt J, Kwakkel G. Stroke rehabilitation. Lancet. 2011 May 14;377(9778):1693-702. doi: 10.1016/S0140-6736(11)60325-5.
- Background: PubMed 20813995Miller EL, Murray L, Richards L, Zorowitz RD, Bakas T, Clark P, Billinger SA; American Heart Association Council on Cardiovascular Nursing and the Stroke Council. Comprehensive overview of nursing and interdisciplinary rehabilitation care of the stroke patient: a scientific statement from the American Heart Association. Stroke. 2010 Oct;41(10):2402-48. doi: 10.1161/STR.0b013e3181e7512b. Epub 2010 Sep 2. No abstract available.
- Background: PubMed 23422082Stewart JC, Cramer SC. Patient-reported measures provide unique insights into motor function after stroke. Stroke. 2013 Apr;44(4):1111-6. doi: 10.1161/STROKEAHA.111.674671. Epub 2013 Feb 19.
- Background: PubMed 23735958Stinear CM, Byblow WD. Letter by Stinear and Byblow regarding article, "patient-reported measures provide unique insights into motor function after stroke". Stroke. 2013 Jul;44(7):e79. doi: 10.1161/STROKEAHA.113.001689. Epub 2013 Jun 4. No abstract available.
- Background: PubMed 17039223Taub E, Uswatte G, Mark VW, Morris DM. The learned nonuse phenomenon: implications for rehabilitation. Eura Medicophys. 2006 Sep;42(3):241-56.
- Background: PubMed 21610863Wolfe CD, Crichton SL, Heuschmann PU, McKevitt CJ, Toschke AM, Grieve AP, Rudd AG. Estimates of outcomes up to ten years after stroke: analysis from the prospective South London Stroke Register. PLoS Med. 2011 May;8(5):e1001033. doi: 10.1371/journal.pmed.1001033. Epub 2011 May 17.
- Background: PubMed 25297823Noorkoiv M, Rodgers H, Price CI. Accelerometer measurement of upper extremity movement after stroke: a systematic review of clinical studies. J Neuroeng Rehabil. 2014 Oct 9;11:144. doi: 10.1186/1743-0003-11-144.
- Background: PubMed 24505342Veerbeek JM, van Wegen E, van Peppen R, van der Wees PJ, Hendriks E, Rietberg M, Kwakkel G. What is the evidence for physical therapy poststroke? A systematic review and meta-analysis. PLoS One. 2014 Feb 4;9(2):e87987. doi: 10.1371/journal.pone.0087987. eCollection 2014.
- Individual participant dataSharing planned: No
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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.
Andreas R Luft, Prof. Dr. study chair
University of Zurich, University Hospital Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by University of Zurich at 1 site in Switzerland.
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 5 inclusion and 3 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 29 Nov 2021. 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 Switzerland. 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?
Daily life assessment of physical activity engagement and upper limb use (time frame: 90 days after stroke onset). 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 NCT03522519, which also lists 13 linked publications.
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 29 Nov 2021.