Encouragement-induced Movement Therapy in Daily Life (ISEAR)
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Wrist-worn wearables
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring Upper Extremity, Feedback, Rehabilitation, Randomized Controlled Trial
Eligibility 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
Sites / Locations
- Cereneo, Center For Neurology and Rehabilitation
- Zürcher RehaZentrum Wald
- University Hospital Zurich
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Monitoring and Feedback
Monitoring
Arm Description
Subjects will use two wrist-worn wearables over a period of 6 weeks. Patients will receive multimodal (vibrotactile and visual) feedback.
Study subjects will use identical devices over a period of 6 weeks. Patients will *not* receive multimodal feedback.
Outcomes
Primary Outcome Measures
Motor Activity Log - 14, Amount of Use sub scale
Self-reported amount of upper limb use in daily life
Secondary Outcome Measures
Fugl-Meyer Assessment, Upper Extremity sub scale
Upper limb motor function
Fugl-Meyer Assessment, Upper Extremity sub scale
Upper limb motor function
Action Research Arm Test
Upper limb capacity
Action Research Arm Test
Upper limb capacity
Modified Rankin Scale
Global Disability
Modified Rankin Scale
Global Disability
EuroQol five dimensions five levels questionnaire
Quality of Life
EuroQol five dimensions five levels questionnaire
Quality of Life
Motor Activity Log - 14, Quality of Movement sub scale
Self-reported quality of upper limb use in daily life
Motor Activity Log - 14, Quality of Movement sub scale
Self-reported quality of upper limb use in daily life
Motor Activity Log - 14, Amount of Use sub scale
Self-reported amount of upper limb use in daily life
Full Information
NCT ID
NCT03294187
First Posted
September 12, 2017
Last Updated
November 25, 2021
Sponsor
University of Zurich
Collaborators
Tyromotion AG, Swiss Federal Institute of Technology in Zurich (ETH Zurich)
1. Study Identification
Unique Protocol Identification Number
NCT03294187
Brief Title
Encouragement-induced Movement Therapy in Daily Life
Acronym
ISEAR
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
September 25, 2017 (Actual)
Primary Completion Date
November 25, 2021 (Actual)
Study Completion Date
November 25, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
Collaborators
Tyromotion AG, Swiss Federal Institute of Technology in Zurich (ETH Zurich)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Upper Extremity, Feedback, Rehabilitation, Randomized Controlled Trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Monitoring and Feedback
Arm Type
Experimental
Arm Description
Subjects will use two wrist-worn wearables over a period of 6 weeks. Patients will receive multimodal (vibrotactile and visual) feedback.
Arm Title
Monitoring
Arm Type
Placebo Comparator
Arm Description
Study subjects will use identical devices over a period of 6 weeks. Patients will *not* receive multimodal feedback.
Intervention Type
Device
Intervention Name(s)
Wrist-worn wearables
Intervention Description
See arm/group description.
Primary Outcome Measure Information:
Title
Motor Activity Log - 14, Amount of Use sub scale
Description
Self-reported amount of upper limb use in daily life
Time Frame
Post-intervention (6 weeks)
Secondary Outcome Measure Information:
Title
Fugl-Meyer Assessment, Upper Extremity sub scale
Description
Upper limb motor function
Time Frame
Post-intervention (6 weeks)
Title
Fugl-Meyer Assessment, Upper Extremity sub scale
Description
Upper limb motor function
Time Frame
Follow-up (12 weeks)
Title
Action Research Arm Test
Description
Upper limb capacity
Time Frame
Post-intervention (6 weeks)
Title
Action Research Arm Test
Description
Upper limb capacity
Time Frame
Follow-up (12 weeks)
Title
Modified Rankin Scale
Description
Global Disability
Time Frame
Post-intervention (6 weeks)
Title
Modified Rankin Scale
Description
Global Disability
Time Frame
Follow-up (12 weeks)
Title
EuroQol five dimensions five levels questionnaire
Description
Quality of Life
Time Frame
Post-intervention (6 weeks)
Title
EuroQol five dimensions five levels questionnaire
Description
Quality of Life
Time Frame
Follow-up (12 weeks)
Title
Motor Activity Log - 14, Quality of Movement sub scale
Description
Self-reported quality of upper limb use in daily life
Time Frame
Post-intervention (6 weeks)
Title
Motor Activity Log - 14, Quality of Movement sub scale
Description
Self-reported quality of upper limb use in daily life
Time Frame
Follow-up (12 weeks)
Title
Motor Activity Log - 14, Amount of Use sub scale
Description
Self-reported amount of upper limb use in daily life
Time Frame
Follow-up (12 weeks)
Other Pre-specified Outcome Measures:
Title
Global Rating of Perceived Change
Time Frame
Post-intervention (6 weeks)
Title
Global Rating of Perceived Change
Time Frame
Follow-up (12 weeks)
Title
Concomitant movement therapy
Description
Time spend at Movement therapy (e.g., Physiotherapy, Occupational therapy)
Time Frame
Post-intervention (6 weeks)
Title
Concomitant movement therapy
Time Frame
Follow-up (12 weeks)
Title
Adverse Events
Description
Safety
Time Frame
Baseline (0 week)
Title
Adverse Events
Description
Safety
Time Frame
Post-intervention (6 weeks)
Title
Adverse Events
Description
Safety
Time Frame
Follow-up (12 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas R Luft, Prof. MD
Organizational Affiliation
University of Zurich
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cereneo, Center For Neurology and Rehabilitation
City
Vitznau
Country
Switzerland
Facility Name
Zürcher RehaZentrum Wald
City
Wald
Country
Switzerland
Facility Name
University Hospital Zurich
City
Zürich
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29422881
Citation
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.
Results Reference
derived
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Encouragement-induced Movement Therapy in Daily Life
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