Air Muscle and Task Practice in Upper Limb Stroke Rehab

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00729625
• Date of registration: 05/08/2008
• Primary sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Public title: Air Muscle and Task Practice in Upper Limb Stroke Rehab
• Scientific title: Air Muscle and Task Practice in Upper Limb Stroke Rehab
• Date of first enrolment: April 2005
• Target sample size: 24
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00729625
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Health Services Research

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Stroke

Intervention(s)

Device: robotic device

Secondary ID(s)

7R21HD045514-03

R21HD045514

Source(s) of Monetary Support

Please refer to primary and secondary sponsors