Air Muscle and Task Practice in Upper Limb Stroke Rehab

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00729625
Recruitment Status : Completed
First Posted : August 7, 2008
Last Update Posted : May 23, 2016
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

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.

Condition or disease Intervention/treatment Phase
Stroke Device: robotic device Early Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Air Muscle and Task Practice in Upper Limb Stroke Rehab
Study Start Date : April 2005
Actual Primary Completion Date : March 2007
Actual Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation
U.S. FDA Resources

Intervention Details:
    Device: robotic device
    The device has a small "air muscle" that when activated will slowly lift their fingers and wrist from your resting wrist position. This device is classified as a non-significant risk device by the FDA (see attached letter dated 1-15-05). The patient should not experience any pain or discomfort during this stretching activity. If they do experience any pain or discomfort they can activate a stop switch located on the control box with their unimpaired hand.
    Other Name: KMI Hand Mentor

Primary Outcome Measures :
  1. Wolf Motor Function Test [ Time Frame: 8 Weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Avery Gottfried, Cleveland Clinic Identifier: NCT00729625     History of Changes
Other Study ID Numbers: R21HD045514 ( U.S. NIH Grant/Contract )
7R21HD045514-03 ( U.S. NIH Grant/Contract )
First Posted: August 7, 2008    Key Record Dates
Last Update Posted: May 23, 2016
Last Verified: April 2005

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
stroke, rehabilitation, robotics

Additional relevant MeSH terms:
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases