Please select the eligibility criteria that correspond to the clinical trial below.
Title: Air Muscle and Task Practice in Upper Limb Stroke Rehab
Brief Summary: Many patients who have sustained strokes are unable to effectively use their hemiparetic upper extremity. Limited mobility in the performance of daily activities, such as eating or dressing, adversely affects their quality of life and compromises independence. Rehabilitation techniques engaging the hemiparetic limb in repetitive task practice (RTP) may improve upper extremity function and quality of life in patients with stroke, but costs limit the number of patients that can utilize this type of therapy. Advances in microprocessor design and function make the use of an assistive device as an adjunct to RTP plausible. An innovative assistive repetitive motion (ARM) device using an "air muscle" has been developed specifically for the rehabilitation of the hemiparetic upper extremity. The primary aim of the proposed study is to collect pilot data to estimate the clinical effectiveness of using the ARM device in conjunction with RTP to improve upper extremity motor function and the quality of life of patients with stroke. Twenty sub-acute (3 to 9 mos. post-stoke) patients will be randomized to a RTP only or ARM + RTP group. The RTP group will receive 15 days (4 hours per day) of intensive one-on-one RTP therapy. The ARM + RTP group will use the ARM device for 2 hours per day and receive 2 hours of intensive RTP per day for 15 days. Clinical motor function and quality of life measures will be taken before and after the interventions and two months later. We hypothesize that the ARM + RTP group will exhibit greater improvements in motor function and quality of life measures than the RTP only group.


Options:
A: Inclusion Criteria:

* A single new focal unilateral stroke with diagnosis verified by brain imaging (MRI) or CT scan that has occurred at least 6 months prior to enrollment.
* Age 18 years of age and older.
* Upper extremity Fugl-Meyer score \>=7 or \<=38 (max 66). (These thresholds include neither hemiplegic nor fully recovered motor function in 14 muscles of the shoulder, elbow, and wrist.)
* Cognitive function sufficient to understand the experiments and follow instructions (Mini-Mental Status Score of 22 and higher or interview for aphasic subjects).
* Willingness to avoid any new alternative arm rehabilitative approaches for the duration of the study.
* Written informed consent to participate in the study.

Exclusion Criteria:

* A fixed contracture in the affected limb that prevents movement along the entire dynamic range required by either robot-assisted or intensive comparison therapy.
* Joint pain that occurs within the range of motion required by the intervention protocols (intensive comparison therapy and robot-assisted therapy).
* Enrolled in or planning to enroll in another interventional research trial that involves the upper limbs using procedures proposed to enhance or limit the function of the upper extremity (such as adjuvant rehabilitation or Botox injections) during the 36 weeks of participation.
* Prior experience with robot-assisted therapy or intensive comparison therapy for the upper limb as described in this specific study.
* A complicating medical condition that would prevent completion of the trial.
* Unable to complete the nine-month study, e.g., extended planned vacation.
* Any other known pre-existing bone diseases that might increase the risk of bone fracture or other injury from intensive comparison therapy or robot-assisted therapy.
B: 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.
C: 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.
D: Inclusion Criteria:

* Subjects must have a clinically, defined, unilateral, hemiparetic stroke with radiologic exclusion of other diagnoses
* Stroke onset greater than six months before randomization for ischemic stroke patients and one year before randomization for hemorrhagic stroke patients
* A grade 3 or lower in Manual Muscle Test in the hemiparetic elbow flexion and shoulder abduction

Exclusion Criteria:

* Subjects unable to give informed consent
* Serious complicating medical illness
* Contracture or orthopedic problems limiting the range of joint movement in the study arm
* Visual loss
* Stroke occurred within 6 months for ischemic stroke patients, one year for hemorrhagic patients
* Botox treatment within 3 months of enrollment

Answer: B