Please select the eligibility criteria that correspond to the clinical trial below.
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
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.


Options:
A: Inclusion Criteria:

* Males, females, or any gender identity 18 years of age or older
* Experienced a stroke resulting in mild-to-moderate hemiparesis at least six months prior to enrollment (suggested range of motion (ROM) criteria includes: 45° shoulder abduction and flexion, 20° elbow extension, 20° wrist extension, and 10° extension of thumb and finger)
* Have preserved ability to comprehend and participate in basic elements of the therapy

Exclusion Criteria:

* Concurrent participation in other experimental trials for motor dysfunction treatment
* Receiving Botox therapy currently or in the past 3 months
* Have medical conditions that would place volunteers at higher risk of adverse events (e.g., renal disease, frailty, pregnancy, dementia, severe pain, end-stage/degenerative diseases)
* Have received intensive upper-extremity rehabilitation in the chronic phase post-stroke
B: Inclusion Criteria:

1. Age ≥ 40 years;
2. Recent stroke (defined as stroke symptoms occurring within 4 weeks prior to admission into community hospitals);
3. Diagnosis of stroke made by clinician and/or supported by brain imaging;
4. Able to sit unsupported for 30 seconds;
5. Able to stand on the non-paretic leg for \>4 sec;
6. Able to walk at least 2m with maximum of 1 person assist;
7. Able to follow a 3-step command;
8. Living in the community before discharge and expected to be discharged home;
9. Has a caregiver.

Exclusion Criteria:

1. Has a pacemaker in-situ (because of possible interference of pacemakers by wireless electronic signals);
2. Unable to ambulate at least 150 feet prior to stroke, or intermittent claudication while walking less than 200 meters;
3. Serious cardiac conditions (hospitalization for myocardial infarction or heart surgery within 3 months, history of severe congestive heart failure, serious and unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living);
4. History of serious chronic obstructive pulmonary disease or oxygen dependence;
5. Severe weight bearing pain;
6. Pre-existing neurological disorders such as Parkinson's disease, Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS) or severe dementia
7. History of major head trauma with severe residual deficits;
8. Lower extremity amputation;
9. Legal blindness or severe visual impairment;
10. Severe uncontrolled psychiatric illness such as psychosis, schizophrenia or medication refractory depression;
11. Life expectancy less than three months;
12. Severe arthritis or orthopedic problems that limit passive ranges of motion of lower extremity (knee flexion contracture of \> 10°, knee flexion ROM \< 90°, hip flexion contracture \> 25°, and ankle plantar flexion contracture \> 15°);
13. History of sustained alcoholism or drug abuse in the last six months;
14. Hypertension with systolic blood pressure greater than 200 mmHg and diastolic blood pressure greater than 110 mmHg at rest, that cannot be medically controlled into the resting range of 180/100 mmHg.
C: Inclusion Criteria:

* Acute cerebrovascular event (ischemic stroke or intra-cerebral bleeding) with signs and symptoms of an acute stroke according to the diagnosis I61 and I63 of the ICD-10-GM 2008
* Differentiation between ischemic or haemorrhagic stroke by the use of CT or MRT
* Resident in Saxony-Anhalt or Saxony or Thuringia
* Able to understand German language

Exclusion Criteria:

* Reinfarction
* Alcoholism
* Death in acute care
* NIHHS \> 25
* Homelessness
D: 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

Answer: D