Please select the eligibility criteria that correspond to the clinical trial below.
Title: Assisted Movement Neuro-rehabilitation: VA Multi-site Clinical Trial
Brief Summary: The purpose of this study is to compare the effectiveness of a lower-dose and higher-dose therapy program for persons recovering from a recent stroke using mechanically-assisted upper limb movement with a device called MIME. A control group receives additional occupational therapy without the use of MIME.


Options:
A: Inclusion Criteria:

* unilateral paresis;
* ability to understand and follow simple instructions;
* minimum ability to perform active movements, even though trunk compensation, using the shoulder and/or the elbow joints.

Exclusion Criteria:

* bilateral impairment;
* severe sensory deficits in the paretic upper limb;
* cognitive impairment or behavioral dysfunction that would influence the ability to understand or perform the experiment;
* inability to provide informed consent;
* other current severe medical problems.
B: Inclusion Criteria:

* Age 18 or more
* first-ever stroke (hemorrhagic or ischemic), verified by brain imaging
* stroke more than six months prior to the study
* termination of conventional therapy and stable recovery stage (outpatients)
* moderate to severe motor impairment of the arm (upper limb portion of FMA score between 8 and 38)
* ability to sit in a chair without any additional support and without leaning on the back rest
* written informed consent signed by the subject (or an authorized representative)

Exclusion Criteria:

* Excessive spasticity of the affected arm (mAS ≥ 3)
* any serious medical or psychiatric illness
* participation in any clinical investigation within 4 weeks prior to the start of this study
* anticipated need for any major surgery during the study
* women known to be pregnant or lactating
* Orthopedic, rheumatologic or other disease restricting movements of the paralyzed upper extremity
* shoulder subluxation (palpatory \> 2 fingers)
* diseased or damaged skin at the paralyzed arm
* inability to communicate effectively with the neurological examiner such that the validity of the patient's data could be compromised
* cyber sickness
* pace-maker or other implanted electric devices
* body weight \> 120kg
* serious cognitive deficits and aphasia preventing the performance of the ARMin treatment
* participation in any therapeutic treatment ("outside therapy") performed with the paralyzed arm during the planned study - including baseline and follow up.
C: Inclusion Criteria:

* Over 21 years of age, weakness due to a recent stroke or other brain injury, and receiving rehabilitation. Subjects are inpatients at one of the participating VA hospitals.

Exclusion Criteria:

Unable to follow instructions; medically unstable.
D: Inclusion criteria Patients will not be excluded because of somatosensory deficits or the nature of previous physical interventions. We will not randomize patients on the basis of side of stroke or hand dominance but will undertake secondary data analyses examining these variables. In past applications of one form of RTP, CI therapy, to chronic stroke patients in the laboratories of Taub and Miltner, there were no significant differences in treatment effects for patients with right and left-sided strokes. In previous evaluations of CI therapy, Taub did not find any difference in outcomes among the small percentage of patients with pre-morbid left dominance. Therefore, there is no reason to exclude these patients from participation. We believe that the motivation to improve use of an affected pre-stroke non-dominant upper extremity is sufficiently strong to support profound improvement from treating that limb as well as from treating the dominant limb. Distributions of dominance and hand preference have been acquired from patients meeting eligibility criteria in 1998 at several sites for determining participation of sites for the EXCITE trial and side of cerebral pathology showed remarkably equal left-right distribution.

Exclusion criteria

1. a score of less than 24 on the Folstein Mini-Mental State Examination or a score of 36 or below on the Token Test of the Multilingual Aphasia Examination
2. a first stroke less than 3 months or more than 9 months prior to the initiation of therapy
3. less than 18 years old
4. clinical judgment of excessive frailty or lack of stamina (e.g., cannot attend to instructions, stay awake, engage in functional activities, etc.)
5. serious uncontrolled medical conditions
6. excessive pain in any joint of the more affected extremity that could limit ability to cooperate with the intervention, as judged by the examining clinician
7. passive range of motion less than 45 degrees for: abduction, flexion or external rotation at shoulder, or pronation of forearm; or greater than 30 degrees flexion contracture at any finger joint (patients who pass the motor criteria specified above do not tend to have the type of pain or limitation of movement that would exclude them from treatment)
8. unable to stand independently for 2 min., transfer independently to and from the toilet or perform sit-to-stand
9. current participation in other pharmacological or physical intervention studies, or have received injections of anti-spasticity drugs into upper extremity musculature within the past 3 months, or wish to have drugs injected in the foreseeable future
10. receiving any anti-spasticity drugs orally at the time of expected participation
11. received phenol injections less than 12 months prior to receiving therapy
12. contemplating a move from proximity to the treatment site in less than 1 year from the randomization date. Prospective patients who qualify but who have profound postural instability will undergo the intervention while walking with contact guarding or, when feasible, using their leg(s) and more involved arm to propel a wheelchair.

Answer: C