Encouragement-induced Movement Therapy in Daily Life

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Device: Wrist-worn wearables

• Registration Number: NCT03294187
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-09-12
• Study First Submitted QC: 2017-09-21
• Study Start: 2017-09-25
• Study First Posted: 2017-09-26
• Status Verified: 2021-11
• Primary Completion: 2021-11-25
• Study Completion: 2021-11-25
• Last Update Submitted: 2021-11-25
• Last Update Posted: 2021-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Monitoring and Feedback	Wrist-worn wearables	Subjects will use two wrist-worn wearables over a period of 6 weeks. Patients will receive multimodal (vibrotactile and visual) feedback.
Monitoring	Wrist-worn wearables	Study subjects will use identical devices over a period of 6 weeks. Patients will \*not\* receive multimodal feedback.

Primary Outcome Measures

Name	Time	Method
Motor Activity Log - 14, Amount of Use sub scale	Post-intervention (6 weeks)	Self-reported amount of upper limb use in daily life

Secondary Outcome Measures

Name	Time	Method
Modified Rankin Scale	Follow-up (12 weeks)	Global Disability
EuroQol five dimensions five levels questionnaire	Follow-up (12 weeks)	Quality of Life
Action Research Arm Test	Follow-up (12 weeks)	Upper limb capacity
Motor Activity Log - 14, Quality of Movement sub scale	Follow-up (12 weeks)	Self-reported quality of upper limb use in daily life
Motor Activity Log - 14, Amount of Use sub scale	Follow-up (12 weeks)	Self-reported amount of upper limb use in daily life
Fugl-Meyer Assessment, Upper Extremity sub scale	Follow-up (12 weeks)	Upper limb motor function

Trial Locations

Locations (3)

Cereneo, Center For Neurology and Rehabilitation; 🇨🇭 Vitznau, Switzerland

University Hospital Zurich; 🇨🇭 Zürich, Switzerland

Zürcher RehaZentrum Wald; 🇨🇭 Wald, Switzerland