Air Muscle and Task Practice in Upper Limb Stroke Rehab
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional
Phase: Early Phase 1

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.
    

Detailed description: 
      Specific Aim 1: Estimate the effectiveness of using an assistive repetitive motion device
      (ARM) in conjunction with repetitive task practice (RTP) on motor recovery of patients with
      sub-acute stroke. This aim will be examined by comparing pre-intervention motor performance
      levels with the immediate post-intervention and two months post-intervention. The primary
      outcome variables will be scores on the Fugl-Meyer Motor Assessment Test (FMA) and Wolf Motor
      Function Test (WMFT). We hypothesize patients in the RTP + ARM group will exhibit greater
      gains in upper extremity motor recovery/performance than the RTP and ARM only groups.

      Specific Aim 2: Estimate the effectiveness of using the ARM device in conjunction with RTP on
      health related quality of life of patients with sub-acute stoke. This aim will be examined
      through the administration of clinical quality of life questionnaires. The primary outcome
      variable to assess health related quality of life will be change scores on the Stroke Impact
      Scale (SIS), controlling for depressed mood as measured by the Center for Epidemiologic
      Studies Depression (CES-D) scale, from the pre-, immediate post and two-month post
      intervention testing sessions. We hypothesize patients in the RTP + ARM group will exhibit
      greater improvements on quality of life measures at the two-month follow-up session than the
      RTP and ARM only groups.

      Study Design, Methods and Procedures:

      Patients will be randomized to one of the following three interventional groups: repetitive
      task practice, assistive repetitive motion and repetitive task practice plus assistive
      repetitive motion. Details regarding the activities each group will perform are below.

        1. Repetitive task practice (RTP) procedure: patients in the RTP group will work closely
           with rehabilitation professional (supervisor) for four hours per day for three weeks. We
           are currently accepting applications for this position. At minimum, this individual will
           be a licensed Physical or Occupational Therapist with clinical experience and a desire
           to participate and follow the outlined research protocol.

           Patients will report to the Mellon Center at the Cleveland Clinic Foundation (CCF)
           around 8:00 AM each day and leave around 12:00 PM. During their stay at the CCF they
           will be asked to engage in a series of activities that are planned for them to use their
           weaker or more impaired hand and arm. We will be making some additional measures about
           the speed at which they can do functional activities (such as reaching and folding a
           towel) during the testing days immediately before and after the training period and two
           months after completion of the training (e.g. Wolf Motor Function Test (WMFT) and
           Fugl-Meyer Motor Assessment (FMA)). Quality of life will be assessed with the Stroke
           Impact Scale (SIS) controlling for depression using the Center for Epidemiologic Studies
           Depression (CES-D) scale. These clinical tests require approximately 1.5 hours to
           administer. Participants will also be encouraged to use their weaker hand and arm at
           home and during the weekends.

        2. Assistive repetitive motion (ARM) procedure: Patients will report to the Mellon Center
           at the Cleveland Clinic Foundation (CCF) around 8:00 AM each day and leave around 12:00
           PM. During their stay at the CCF they will be asked to wear an assistive device on their
           more impaired or affected upper extremity. This device will be placed snugly on their
           arm and wrist. 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. The SIS, CES-D WMFT and FMA will be administered
           immediately before and after the training period and two months after completion of the
           training.

        3. RTP + ARM Procedure: Patients will report to the Mellon Center at the Cleveland Clinic
           Foundation (CCF) around 8:00 AM each day and leave around 12:00 PM. During their stay at
           the CCF they will be asked to wear an assistive device on their more impaired or
           affected upper extremity for two hours. This device will be placed snugly on their arm
           and wrist. The device has a small "air muscle" that when activated will slowly lift the
           fingers and wrist from a resting wrist position. They should not experience any pain or
           discomfort during this stretching activity. If they experience any pain or discomfort
           they can activate a stop switch located on the control box with the unimpaired hand.
           After completion of the two hour ARM intervention they will participate in two hours of
           RTP therapy. During this time they will engage in a series of activities that are
           planned for them to use the weaker or more impaired hand and arm. The SIS, CES-D WMFT
           and FMA will be administered immediately before and after the training period and two
           months after completion of the training.

      The results from this project will provide valuable data as a pre-requisite for submission of
      a multi-year R01 randomized clinical trial to determine the clinical efficacy of using an
      assistive device, such as the ARM, as an adjunct to RTP. This project has the potential to
      increase the availability of effective rehabilitation techniques to patients with stroke.

      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.
    

Intervention name(s): robotic device
Intervention type(s): Device
Intervention description(s): 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 intervention name(s): KMI Hand Mentor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: stroke, rehabilitation, robotics