NCT03522519: REUSE

Predicting Real World Physical Activity and Upper Limb Use After Stroke

Completed Last updated 29 November 2021

What this trial tests

trial testing Real world performance of physical activity and arm use in Stroke in 98 participants. Completed in 31 March 2021.

Timeline

1 September 2018

Primary endpoint
31 March 2021

31 March 2021

Quick facts

Lead sponsor	University of Zurich
Status	Completed
Study type	OBSERVATIONAL
Enrollment	98
Start date	1 September 2018
Primary completion	31 March 2021
Estimated completion	31 March 2021
Sites	1 location across Switzerland

Drugs / interventions tested

• Real world performance of physical activity and arm use

Conditions studied

• Stroke — all drugs for Stroke →

Sponsor

University of Zurich

Who can join

18 and older, any sex, with Stroke. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

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

1. External Validation of the Early Prediction of Functional Outcome After Stroke Prediction Model for Independent Gait at 3 Months After Stroke.
   Veerbeek JM, Pohl J, Held JPO, Luft AR. · · 2022 · cited 9× · PMID 35585839 · DOI 10.3389/fneur.2022.797791
2. External validation and extension of the Early Prediction of Functional Outcome after Stroke (EPOS) prediction model for upper limb outcome 3 months after stroke.
   Veerbeek JM, Pohl J, Luft AR, Held JPO. · · 2022 · cited 8× · PMID 35939514 · DOI 10.1371/journal.pone.0272777
3. Construct validity and responsiveness of clinical upper limb measures and sensor-based arm use within the first year after stroke: a longitudinal cohort study.
   Pohl J, Verheyden G, Held JPO, Luft AR, et al · · 2025 · cited 7× · PMID 39881332 · DOI 10.1186/s12984-024-01512-9
4. Changes in Stroke Rehabilitation during the Sars-Cov-2 Shutdown in Switzerland.
   Held JPO, Schwarz A, Pohl J, Thürlimann E, et al · · 2022 · cited 5× · PMID 34927210 · DOI 10.2340/jrm.v53.1118
5. The association between dexterity and upper limb impairment during stroke recovery.
   Valladares B, Kundert RG, Pohl J, Held JPO, et al · · 2024 · cited 3× · PMID 39224885 · DOI 10.3389/fneur.2024.1429929
6. Concurrent Validity and Responsiveness of Clinical Upper Limb Outcome Measures and Sensor-based Arm Use Metrics within the First Year after Stroke: A Longitudinal Cohort Study
   Pohl J, Verheyden G, Held JPO, Luft A, et al · · 2024 · DOI 10.21203/rs.3.rs-4103325/v1