Encouragement-induced Movement Therapy in Daily Life (ISEAR)

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Device: Wrist-worn wearables

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Vitznau, Switzerland
    • Cereneo, Center For Neurology and Rehabilitation
  • Wald, Switzerland
    • Zürcher RehaZentrum Wald
  • Zürich, Switzerland
    • University Hospital Zurich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global Rating of Perceived Change		Post-intervention (6 weeks)
Global Rating of Perceived Change		Follow-up (12 weeks)
Concomitant movement therapy	Time spend at Movement therapy (e.g., Physiotherapy, Occupational therapy)	Post-intervention (6 weeks)
Concomitant movement therapy		Follow-up (12 weeks)
Adverse Events	Safety	Baseline (0 week)
Adverse Events	Safety	Post-intervention (6 weeks)
Adverse Events	Safety	Follow-up (12 weeks)

Collaborators and Investigators

• Sponsor: University of Zurich
• Collaborators: Swiss Federal Institute of Technology in Zurich (ETH Zurich); Tyromotion AG
• Investigators: Principal Investigator: Andreas R Luft, Prof. MD, University of Zurich

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2017
• Primary Completion (Actual): November 25, 2021
• Study Completion (Actual): November 25, 2021

Study Registration Dates

• First Submitted: September 12, 2017
• First Submitted That Met QC Criteria: September 21, 2017
• First Posted (Actual): September 26, 2017

Study Record Updates

• Last Update Posted (Actual): December 8, 2021
• Last Update Submitted That Met QC Criteria: November 25, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Rehabilitation; Randomized Controlled Trial; Upper Extremity; Feedback
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 2017-00948

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No