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Completed

NCT Number: NCT03294187

Encouragement-induced Movement Therapy in Daily Life

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cereneo, Center For Neurology and Rehabilitation, Vitznau, Switzerland

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Wrist-worn wearables

Device

See arm/group description.

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Collaborators

  • Swiss Federal Institute of Technology in Zurich (ETH Zurich)
  • Tyromotion AG

Registry information

Official study 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

Acronym: ISEAR

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Sep 26, 2017
Registry last updated
Dec 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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