Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
42 participants
INTERVENTIONAL
2017-09-25
2021-11-25
Brief Summary
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The primary objective of this study is to determine the effect of wearing an activity tracking and multimodal feedback device for six weeks on self-reported daily life use of the paretic arm after stroke, when compared to control group stroke subjects wearing a hardware-wise identical sham device providing no feedback. The secondary aim is to examine compliance to use the device and the quantitative, qualitative and functional improvement of the paretic arm. It is hypothesized that participants in the experimental group show a higher change in self-reported daily life use of the paretic arm when compared to the control group both post intervention and at 6-week follow-up.
ISEAR is a multicenter, assessor-blinded randomized controlled trial of 62 subjects beyond the first 3 months poststroke.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Monitoring and Feedback
Subjects will use two wrist-worn wearables over a period of 6 weeks. Patients will receive multimodal (vibrotactile and visual) feedback.
Wrist-worn wearables
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Monitoring
Study subjects will use identical devices over a period of 6 weeks. Patients will \*not\* receive multimodal feedback.
Wrist-worn wearables
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Interventions
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Wrist-worn wearables
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Eligibility Criteria
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Inclusion Criteria
* Ability to lift arm against gravity (\>30 degrees flexion or abduction)
* Ability to don/doff the devices on both wrists independently or with assistance of a caregiver
* Ability to give informed consent as documented by signature
Exclusion Criteria
* Severe cognitive impairment
* Suffering from comprehensive aphasia
* Severely impaired sensation (unable to feel a soft touch on the dorsal side of their paretic wrist with closed eyes)
* Other major comorbidities (e.g., cardiopulmonary disease, renal failure, hepatic dysfunction, orthopedic disorders, etc.)
* Expected hospitalization during study period
* Known intolerance to device material
* Known or suspected non-compliance, drug or alcohol abuse
* The investigator, his/her family members, employees, and other dependent persons
18 Years
ALL
No
Sponsors
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Tyromotion AG
UNKNOWN
Swiss Federal Institute of Technology in Zurich (ETH Zurich)
UNKNOWN
University of Zurich
OTHER
Responsible Party
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Principal Investigators
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Andreas R Luft, Prof. MD
Role: PRINCIPAL_INVESTIGATOR
University of Zurich
Locations
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Cereneo, Center For Neurology and Rehabilitation
Vitznau, , Switzerland
Zürcher RehaZentrum Wald
Wald, , Switzerland
University Hospital Zurich
Zurich, , Switzerland
Countries
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References
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Mayrhuber L, Andres SD, Legrand ML, Luft AR, Ryser F, Gassert R, Veerbeek JM, Duinen JV, Schwarz A, Franinovic K, Rickert C, Schkommodau E, O Held JP, Easthope CA, Lambercy O. Encouraging arm use in stroke survivors: the impact of smart reminders during a home-based intervention. J Neuroeng Rehabil. 2024 Dec 21;21(1):220. doi: 10.1186/s12984-024-01527-2.
Held JPO, Luft AR, Veerbeek JM. Encouragement-Induced Real-World Upper Limb Use after Stroke by a Tracking and Feedback Device: A Study Protocol for a Multi-Center, Assessor-Blinded, Randomized Controlled Trial. Front Neurol. 2018 Jan 25;9:13. doi: 10.3389/fneur.2018.00013. eCollection 2018.
Other Identifiers
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2017-00948
Identifier Type: -
Identifier Source: org_study_id