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Evaluation of Robot Assisted Neuro-Rehabilitation (SRT3)

This study has been completed.
Sponsor:
Collaborators:
Massachusetts Institute of Technology
University of Maryland
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01253018
First received: November 24, 2010
Last updated: February 1, 2016
Last verified: February 2016

November 24, 2010
February 1, 2016
April 2011
January 2015   (final data collection date for primary outcome measure)
Fugl-Meyer Motor Upper Extremity Assessment [ Time Frame: Baseline, 12 week, and 24 week retention ] [ Designated as safety issue: No ]
This is a stroke-specific measure of impairment of the upper extremity that has been shown to be valid and reliable with high inter-rater and test-retest reliability. It provides a direct-observational assessment of volitional movement and motor impairment related to reflexes, sensation, and abnormal synergies. Each item on the FM is rated on a three-point ordinal scale (0 = cannot perform, 1 = performs partially, 2 = performs fully). The scale ranges from 0-66 with higher scores representing less motor impairment.
Upper Extremity Impairment as measured by the Fugl-Meyer Motor Assessment [ Time Frame: week 12 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01253018 on ClinicalTrials.gov Archive Site
  • Motor Cortex Excitability Via Transcranial Magnetic Stimulation (TMS) [ Time Frame: week 12 ] [ Designated as safety issue: No ]
  • Wolf Motor Function Test (WMFT) [ Time Frame: Baseline, 12 week, and 24 week retention ] [ Designated as safety issue: No ]
    The Wolf Motor Function Test (WMFT) examines UE function based on task performance time, quality of movement, and ability to hold a weight. Functional use and speed of movement are based on fifteen timed activities and two strength activities. It has high inter-rater reliability, internal consistency, and test-retest reliability. Timed tasks that cannot be completed default to a time score of 120 seconds. Faster times or a lower score in seconds represent better function. Improvement is represented by a decreased time to complete the tasks therefore a negative change score from baseline to follow-up indicates improvement.
  • Stroke Impact Scale: Hand Subscale [ Time Frame: Baseline, 12 week and 24 week retention ] [ Designated as safety issue: No ]
    The Stroke Impact Scale (SIS) is a self-report structured interview consisting of eight domains designed to assess changes in impairment, disabilities, and handicap following stroke that contribute to quality of life. It has been tested and found to be reliable, valid, and sensitive to change in the stroke population. There are four physical domains that that can be analyzed separately. The hand domain was analyzed for this study and the scores for this domain range from 0-100. Higher scores indicate greater function.
Motor Cortex Excitability via Trancranial Magnetic Stimulation (TMS) [ Time Frame: week 12 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Evaluation of Robot Assisted Neuro-Rehabilitation
Evaluation of Robot Assisted Neuro-rehabilitation
Robotic devices are capable of providing therapy to the arm of patients with weakness due to stroke. Robotic therapy improves some aspects of stroke related arm weakness, but the use of the weak arm for real life situations often remains limited. The goal of this study is to determine the best way to use robotic devices and functional task training to improve the use of the stroke affected arm for real life situations. A secondary goal of this study is to determine how or if specific areas of the brain are excited before and after training. The use of a safe and painless magnetic field directed at the brain called transcranial magnetic stimulation (TMS) will be used at set intervals to gain a better understanding of brain activity during recovery.

After obtaining informed consent, participants will undergo 3 sessions of baseline testing using upper extremity motor assessments of the shoulder, elbow, wrist, thumb and grip. Upper extremity kinematic and strength testing will be performed with the rehabilitation robots in measurement mode. The rehabilitation robot modules include the wrist, the planar (shoulder-elbow), and alternating wrist and shoulder-elbow robot. These robotic devices are cleared for marketing as a registered medical device under U.S. FDA regulations and are listed with the FDA both as an evaluation devices and as therapy devices.

Patients will be randomized to receive 12 weeks of robotic therapy sessions or 12 weeks of robot therapy combined with transition to task therapy. Study interventions will occur 3 times a week for 12 weeks. Robot therapy will consist of a progression through three robot modules: wrist, planar, and alternating wrist and shoulder-elbow robot. The progression will be sequential with four weeks of training on each robotic device. All participants will complete a motor activity log during this intervention phase.

TMS is being used for physiological measurement and evaluations will be conducted with each participant at baseline, week one, week five, eight, and final. TMS will also occur during the follow-up on week twenty-four.

Disability and depression questionnaires, upper extremity measures and evaluations of functional performance will be conducted during the study at baseline, and at training completion (visit 36). Patients will return twelve weeks after the end of the training period to determine whether any observed improvements persist.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Stroke
  • Behavioral: Robot Therapy
    Robot assisted arm exercise for 60 minutes progressing each month through three robot modules: wrist, planar, and alternating sessions on the wrist and planar robot 3x/week for 12 weeks.
    Other Name: Upper extremity (UE) robot-assisted exercise
  • Behavioral: Transition to Task Training
    Robot therapy as described for 45 minutes and 15 minutes of task specific arm exercise using the hemiparetic arm 3x/week for 12 weeks.
  • Experimental: Robot Therapy
    12 weeks of robotic therapy
    Intervention: Behavioral: Robot Therapy
  • Active Comparator: Transition to Task Training
    12 weeks of task specific practice combined with robotic therapy
    Intervention: Behavioral: Transition to Task Training
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
59
January 2015
January 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Clinically defined, unilateral, hemiparetic stroke with radiologic exclusion of other possible diagnoses
  • Adequate language, and cognitive function to participate in training, testing, and informed consent process
  • The study arm of the participant will present with moderate to severe dysfunction based on Fugl-Meyer Motor Assessment range of 7 to 38
  • Stroke onset greater than 6 months for ischemic stroke and greater than 1 year for hemorrhagic stroke
  • Men or women over 21 years of age

Exclusion Criteria:

  • Seizures or treatment with anticonvulsant medications within the last 10 years (This criteria does not preclude participation in the study, but does preclude participation in the TMS testing)
  • Treatment with any medications known to interfere with brain stimulation: any medication with central nervous system depressant activity, including, but not limited to benzodiazepines, barbiturates, and neuroleptics (This criteria does not preclude participation in the study, but does preclude participation in the TMS testing)
  • Serious complicating medical conditions, contractures or orthopedic problems in the study arm limiting the range of joint movement for the study positions
  • Visual loss such that the participant cannot see the test patterns on the monitor of the training robot computer
  • Botox injection to the study arm within 3 months of enrollment or during the study period
  • Any change in the exercise regime involving the study arm. This includes starting any new exercise or discontinuing any current exercise regimen
Both
21 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01253018
B6935-R
Yes
Not Provided
Not Provided
VA Office of Research and Development
VA Office of Research and Development
  • Massachusetts Institute of Technology
  • University of Maryland
Principal Investigator: Christopher Bever, MD Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
VA Office of Research and Development
February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP