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Encouragement-induced Movement Therapy in Daily Life (ISEAR)

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ClinicalTrials.gov Identifier: NCT03294187
Recruitment Status : Recruiting
First Posted : September 26, 2017
Last Update Posted : January 29, 2019
Sponsor:
Collaborators:
yband therapy AG
Swiss Federal Institute of Technology in Zurich (ETH Zurich)
Information provided by (Responsible Party):
University of Zurich

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Stroke Device: Wrist-worn wearables Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : September 25, 2017
Estimated Primary Completion Date : January 31, 2021
Estimated Study Completion Date : January 31, 2021

Arm Intervention/treatment
Experimental: Monitoring and Feedback
Subjects will use two wrist-worn wearables over a period of 6 weeks. Patients will receive multimodal (vibrotactile and visual) feedback.
Device: Wrist-worn wearables
See arm/group description.

Placebo Comparator: Monitoring
Study subjects will use identical devices over a period of 6 weeks. Patients will *not* receive multimodal feedback.
Device: Wrist-worn wearables
See arm/group description.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Fugl-Meyer Assessment, Upper Extremity sub scale [ Time Frame: Post-intervention (6 weeks) ]
    Upper limb motor function

  2. Fugl-Meyer Assessment, Upper Extremity sub scale [ Time Frame: Follow-up (12 weeks) ]
    Upper limb motor function

  3. Action Research Arm Test [ Time Frame: Post-intervention (6 weeks) ]
    Upper limb capacity

  4. Action Research Arm Test [ Time Frame: Follow-up (12 weeks) ]
    Upper limb capacity

  5. Modified Rankin Scale [ Time Frame: Post-intervention (6 weeks) ]
    Global Disability

  6. Modified Rankin Scale [ Time Frame: Follow-up (12 weeks) ]
    Global Disability

  7. EuroQol five dimensions five levels questionnaire [ Time Frame: Post-intervention (6 weeks) ]
    Quality of Life

  8. EuroQol five dimensions five levels questionnaire [ Time Frame: Follow-up (12 weeks) ]
    Quality of Life

  9. Motor Activity Log - 14, Quality of Movement sub scale [ Time Frame: Post-intervention (6 weeks) ]
    Self-reported quality of upper limb use in daily life

  10. Motor Activity Log - 14, Quality of Movement sub scale [ Time Frame: Follow-up (12 weeks) ]
    Self-reported quality of upper limb use in daily life

  11. Motor Activity Log - 14, Amount of Use sub scale [ Time Frame: Follow-up (12 weeks) ]
    Self-reported amount of upper limb use in daily life


Other Outcome Measures:
  1. Global Rating of Perceived Change [ Time Frame: Post-intervention (6 weeks) ]
  2. Global Rating of Perceived Change [ Time Frame: Follow-up (12 weeks) ]
  3. Concomitant movement therapy [ Time Frame: Post-intervention (6 weeks) ]
    Time spend at Movement therapy (e.g., Physiotherapy, Occupational therapy)

  4. Concomitant movement therapy [ Time Frame: Follow-up (12 weeks) ]
  5. Adverse Events [ Time Frame: Baseline (0 week) ]
    Safety

  6. Adverse Events [ Time Frame: Post-intervention (6 weeks) ]
    Safety

  7. Adverse Events [ Time Frame: Follow-up (12 weeks) ]
    Safety



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03294187


Contacts
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Contact: Jeremia PO Held +41442555645 jeremia.held@uzh.ch
Contact: Janne M Veerbeek, PhD +41442555645 janne.veerbeek@uzh.ch

Locations
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Switzerland
Cereneo, Center For Neurology and Rehabilitation Not yet recruiting
Vitznau, Switzerland
Contact: Leopold Zizlsperger, MD         
Zürcher RehaZentrum Wald Not yet recruiting
Wald, Switzerland
Contact: Antonella Palla, MD         
University Hospital Zurich Recruiting
Zürich, Switzerland
Contact: Jeremia Held         
Sponsors and Collaborators
University of Zurich
yband therapy AG
Swiss Federal Institute of Technology in Zurich (ETH Zurich)
Investigators
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Principal Investigator: Andreas R Luft, Prof. MD University of Zurich

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT03294187     History of Changes
Other Study ID Numbers: 2017-00948
First Posted: September 26, 2017    Key Record Dates
Last Update Posted: January 29, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Zurich:
Upper Extremity
Feedback
Rehabilitation
Randomized Controlled Trial
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases