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| Name | Class |
|---|---|
| Tyromotion AG | UNKNOWN |
| Swiss Federal Institute of Technology in Zurich (ETH Zurich) | UNKNOWN |
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Stroke places a major burden on health care and society. It often leads to a hemiparesis. Intensive stroke rehabilitation speeds up recovery. In daily practice, the financial and/or human resources to provide this intensive rehabilitation are often lacking. Applying modern-day tracking and feedback technology to encourage a self-administered, context specific training is expected to offer significant potential to increase intensity of practice. Up until now, there has been no randomized trial examining the effect of such an intervention on daily arm usage.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Monitoring and Feedback | Experimental | Subjects will use two wrist-worn wearables over a period of 6 weeks. Patients will receive multimodal (vibrotactile and visual) feedback. |
|
| Monitoring | Placebo Comparator | Study subjects will use identical devices over a period of 6 weeks. Patients will *not* receive multimodal feedback. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wrist-worn wearables | Device | See arm/group description. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Motor Activity Log - 14, Amount of Use sub scale | Self-reported amount of upper limb use in daily life | Post-intervention (6 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Fugl-Meyer Assessment, Upper Extremity sub scale | Upper limb motor function | Post-intervention (6 weeks) |
| Fugl-Meyer Assessment, Upper Extremity sub scale | Upper limb motor function |
| Measure | Description | Time Frame |
|---|---|---|
| Global Rating of Perceived Change | Post-intervention (6 weeks) | |
| Global Rating of Perceived Change | Follow-up (12 weeks) | |
| Concomitant movement therapy |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andreas R Luft, Prof. MD | University of Zurich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cereneo, Center For Neurology and Rehabilitation | Vitznau | Switzerland | ||||
| Zürcher RehaZentrum Wald |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39707385 | Derived | 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. | |
| 29422881 |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Follow-up (12 weeks) |
| Action Research Arm Test | Upper limb capacity | Post-intervention (6 weeks) |
| Action Research Arm Test | Upper limb capacity | Follow-up (12 weeks) |
| Modified Rankin Scale | Global Disability | Post-intervention (6 weeks) |
| Modified Rankin Scale | Global Disability | Follow-up (12 weeks) |
| EuroQol five dimensions five levels questionnaire | Quality of Life | Post-intervention (6 weeks) |
| EuroQol five dimensions five levels questionnaire | Quality of Life | Follow-up (12 weeks) |
| Motor Activity Log - 14, Quality of Movement sub scale | Self-reported quality of upper limb use in daily life | Post-intervention (6 weeks) |
| Motor Activity Log - 14, Quality of Movement sub scale | Self-reported quality of upper limb use in daily life | Follow-up (12 weeks) |
| Motor Activity Log - 14, Amount of Use sub scale | Self-reported amount of upper limb use in daily life | Follow-up (12 weeks) |
Time spend at Movement therapy (e.g., Physiotherapy, Occupational therapy) |
| Post-intervention (6 weeks) |
| Concomitant movement therapy | Follow-up (12 weeks) |
| Adverse Events | Safety | Baseline (0 week) |
| Adverse Events | Safety | Post-intervention (6 weeks) |
| Adverse Events | Safety | Follow-up (12 weeks) |
| Wald |
| Switzerland |
| University Hospital Zurich | Zurich | Switzerland |
| 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. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |