Encouragement-induced Movement Therapy in Daily Life

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Stroke

Intervention / Treatment
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* Device: Wrist-worn wearables


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Monitoring and Feedback<br>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<br>* See arm/group description.<br>|
| Placebo Comparator: Monitoring<br>Study subjects will use identical devices over a period of 6 weeks. Patients will *not* receive multimodal feedback. | Device: Wrist-worn wearables<br>* See arm/group description.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Upper Extremity, Feedback, Rehabilitation, Randomized Controlled Trial