StrokeISEARNCT03294187
Encouragement-induced Movement Therapy in Daily Life
A study testing Wrist-worn wearables in people with Stroke, run by University of Zurich at 3 sites in Switzerland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Wrist-worn wearables
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 3 sitesSwitzerland
- Study dates
- 25 Sep 2017to 25 Nov 2021
- 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
- Above 18 years of age with unilateral stroke and residual hemiparesis leading to a decrease of arm function after completion of all inpatient rehabilitation (at least 90 days post stroke)
- 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
Who cannot join
- Major untreated depression
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
Switzerland3 sites
Cereneo, Center For Neurology and Rehabilitation
Vitznau
Zürcher RehaZentrum Wald
Wald
University Hospital Zurich
Zurich
About this study
Official title: Encouragement-induced Movement Therapy in Daily Life - a Randomized Controlled, Assessor-blinded Multi-center Trial in Stroke Patients With a Unilateral Hemiparesis, Using a Wrist-worn Tracking and Feedback Device
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.
- Conditions
- Stroke
- Being tested
- Wrist-worn wearables
- Keywords
- Upper Extremity, Feedback, Rehabilitation, Randomized Controlled Trial
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wrist-worn wearablesDevice
See arm/group description.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Wrist-worn wearables |
| Monitoring | Placebo comparator | Study subjects will use identical devices over a period of 6 weeks. Patients will *not* receive multimodal feedback. Receives: Device: Wrist-worn wearables |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor Activity Log - 14, Amount of Use sub scale
Self-reported amount of upper limb use in daily life
Measured: Post-intervention (6 weeks)
Secondary outcomes (11)
Fugl-Meyer Assessment, Upper Extremity sub scale
Upper limb motor function
Measured: Post-intervention (6 weeks)
Fugl-Meyer Assessment, Upper Extremity sub scale
Upper limb motor function
Measured: Follow-up (12 weeks)
Action Research Arm Test
Upper limb capacity
Measured: Post-intervention (6 weeks)
Action Research Arm Test
Upper limb capacity
Measured: Follow-up (12 weeks)
Modified Rankin Scale
Global Disability
Measured: Post-intervention (6 weeks)
Modified Rankin Scale
Global Disability
Measured: Follow-up (12 weeks)
EuroQol five dimensions five levels questionnaire
Quality of Life
Measured: Post-intervention (6 weeks)
EuroQol five dimensions five levels questionnaire
Quality of Life
Measured: Follow-up (12 weeks)
Motor Activity Log - 14, Quality of Movement sub scale
Self-reported quality of upper limb use in daily life
Measured: Post-intervention (6 weeks)
Motor Activity Log - 14, Quality of Movement sub scale
Self-reported quality of upper limb use in daily life
Measured: Follow-up (12 weeks)
Motor Activity Log - 14, Amount of Use sub scale
Self-reported amount of upper limb use in daily life
Measured: Follow-up (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2017
- Study start25 Sep 2017
- Primary completion25 Nov 2021
- Study completion25 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Tyromotion AG, Swiss Federal Institute of Technology in Zurich (ETH Zurich)
- Responsible party
- Sponsor
- Investigators
- Andreas R Luft, Prof. MD, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03294187
- Sponsor's protocol ID
- 2017-00948
- Other IDs
- 2017
- Acronym
- ISEAR
- Status last verified
- Nov 2021
- First submitted
- 12 Sep 2017
- Last updated
- 8 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39707385Held 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.
PubMed 29422881
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Encouragement-induced Movement Therapy in Daily Life - a Randomized Controlled, Assessor-blinded Multi-center Trial in Stroke Patients With a Unilateral Hemiparesis, Using a Wrist-worn Tracking and Feedback Device
- ClinicalTrials.gov ID
- NCT03294187
- Acronym / sponsor ID
- ISEAR / 2017-00948
- Conditions
- Stroke
- Keywords
- Upper Extremity, Feedback, Rehabilitation, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Tyromotion AG, Swiss Federal Institute of Technology in Zurich (ETH Zurich)
- Study start
- 25 Sep 2017 (actual)
- Primary completion
- 25 Nov 2021 (actual)
- Study completion
- 25 Nov 2021 (actual)
- First posted
- 26 Sep 2017 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Monitoring and Feedback | Experimental | Device: Wrist-worn wearablesSubjects will use two wrist-worn wearables over a period of 6 weeks. Patients will receive multimodal (vibrotactile and visual) feedback. |
| Monitoring | Placebo comparator | Device: Wrist-worn wearablesStudy subjects will use identical devices over a period of 6 weeks. Patients will *not* receive multimodal feedback. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Above 18 years of age with unilateral stroke and residual hemiparesis leading to a decrease of arm function after completion of all inpatient rehabilitation (at least 90 days post stroke)
- 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
Key exclusion criteria (9 listed)
- Major untreated depression
- 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.)
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 |
|---|---|---|
| Wrist-worn wearablesSee arm/group description. | Device | Monitoring, Monitoring and Feedback |
Primary outcome
Motor Activity Log - 14, Amount of Use sub scale
Time frame: Post-intervention (6 weeks)
Self-reported amount of upper limb use in daily life
11 secondary outcomes
Fugl-Meyer Assessment, Upper Extremity sub scale
Time frame: Post-intervention (6 weeks)
Fugl-Meyer Assessment, Upper Extremity sub scale
Time frame: Follow-up (12 weeks)
Action Research Arm Test
Time frame: Post-intervention (6 weeks)
Action Research Arm Test
Time frame: Follow-up (12 weeks)
Modified Rankin Scale
Time frame: Post-intervention (6 weeks)
Modified Rankin Scale
Time frame: Follow-up (12 weeks)
EuroQol five dimensions five levels questionnaire
Time frame: Post-intervention (6 weeks)
EuroQol five dimensions five levels questionnaire
Time frame: Follow-up (12 weeks)
Motor Activity Log - 14, Quality of Movement sub scale
Time frame: Post-intervention (6 weeks)
Motor Activity Log - 14, Quality of Movement sub scale
Time frame: Follow-up (12 weeks)
Motor Activity Log - 14, Amount of Use sub scale
Time frame: Follow-up (12 weeks)
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 Dec 2021.
- Derived from this study: PubMed 39707385Mayrhuber 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.
- Derived from this study: PubMed 29422881Held 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.
- Individual participant dataSharing planned: No
Related trials for Stroke
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Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
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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. MD principal investigator
University of Zurich
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wrist-worn wearables in people with Stroke, run by University of Zurich at 3 sites 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 4 inclusion and 9 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 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. Some participants in this study may receive a placebo. 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?
Motor Activity Log - 14, Amount of Use sub scale (time frame: Post-intervention (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 NCT03294187, which also lists 2 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 8 Dec 2021.