Clinical trial NCT03294187: Encouragement-induced Movement Therapy in Daily Life
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
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Upper Extremity
Feedback
Rehabilitation
Randomized Controlled Trial
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Tyromotion AG
name: Swiss Federal Institute of Technology in Zurich (ETH Zurich)
First posted: 2017-09-26
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Motor Activity Log - 14, Amount of Use sub scale
timeFrame: Post-intervention (6 weeks)
Secondary outcomes:
measure: Fugl-Meyer Assessment, Upper Extremity sub scale
timeFrame: Post-intervention (6 weeks)
measure: Fugl-Meyer Assessment, Upper Extremity sub scale
timeFrame: Follow-up (12 weeks)
measure: Action Research Arm Test
timeFrame: Post-intervention (6 weeks)
measure: Action Research Arm Test
timeFrame: Follow-up (12 weeks)
measure: Modified Rankin Scale
timeFrame: Post-intervention (6 weeks)
measure: Modified Rankin Scale
timeFrame: Follow-up (12 weeks)
measure: EuroQol five dimensions five levels questionnaire
timeFrame: Post-intervention (6 weeks)
measure: EuroQol five dimensions five levels questionnaire
timeFrame: Follow-up (12 weeks)
measure: Motor Activity Log - 14, Quality of Movement sub scale
timeFrame: Post-intervention (6 weeks)
measure: Motor Activity Log - 14, Quality of Movement sub scale
timeFrame: Follow-up (12 weeks)
measure: Motor Activity Log - 14, Amount of Use sub scale
timeFrame: Follow-up (12 weeks)
Other outcomes:
measure: Global Rating of Perceived Change
timeFrame: Post-intervention (6 weeks)
measure: Global Rating of Perceived Change
timeFrame: Follow-up (12 weeks)
measure: Concomitant movement therapy
timeFrame: Post-intervention (6 weeks)
measure: Concomitant movement therapy
timeFrame: Follow-up (12 weeks)
measure: Adverse Events
timeFrame: Baseline (0 week)
measure: Adverse Events
timeFrame: Post-intervention (6 weeks)
measure: Adverse Events
timeFrame: Follow-up (12 weeks)
Locations:
city: Vitznau
country: Switzerland
facility: Cereneo, Center For Neurology and Rehabilitation
city: Wald
country: Switzerland
facility: Zürcher RehaZentrum Wald
city: Zürich
country: Switzerland
facility: University Hospital Zurich
Study officials:
affiliation: University of Zurich
name: Andreas R Luft, Prof. MD
role: PRINCIPAL_INVESTIGATOR
References:
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.