Evaluation of Robot Assisted Neuro-Rehabilitation (SRT3)
Primary Purpose
Stroke
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Robot Therapy
Transition to Task Training
Sponsored by

About this trial
This is an interventional treatment trial for Stroke focused on measuring stroke, robotics, upper extremity rehabilitation
Eligibility Criteria
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
Sites / Locations
- Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Robot Therapy
Transition to Task Training
Arm Description
12 weeks of robotic therapy
12 weeks of task specific practice combined with robotic therapy
Outcomes
Primary Outcome Measures
Fugl-Meyer Motor Upper Extremity Assessment
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.
Secondary Outcome Measures
Motor Cortex Excitability Via Transcranial Magnetic Stimulation (TMS)
Wolf Motor Function Test (WMFT)
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
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.
Full Information
NCT ID
NCT01253018
First Posted
November 24, 2010
Last Updated
October 17, 2019
Sponsor
VA Office of Research and Development
Collaborators
Massachusetts Institute of Technology, University of Maryland, College Park
1. Study Identification
Unique Protocol Identification Number
NCT01253018
Brief Title
Evaluation of Robot Assisted Neuro-Rehabilitation
Acronym
SRT3
Official Title
Evaluation of Robot Assisted Neuro-rehabilitation
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
April 27, 2011 (Actual)
Primary Completion Date
January 16, 2015 (Actual)
Study Completion Date
January 30, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
Collaborators
Massachusetts Institute of Technology, University of Maryland, College Park
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
stroke, robotics, upper extremity rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
59 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Robot Therapy
Arm Type
Experimental
Arm Description
12 weeks of robotic therapy
Arm Title
Transition to Task Training
Arm Type
Active Comparator
Arm Description
12 weeks of task specific practice combined with robotic therapy
Intervention Type
Behavioral
Intervention Name(s)
Robot Therapy
Other Intervention Name(s)
Upper extremity (UE) robot-assisted exercise
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Transition to Task Training
Intervention Description
Robot therapy as described for 45 minutes and 15 minutes of task specific arm exercise using the hemiparetic arm 3x/week for 12 weeks.
Primary Outcome Measure Information:
Title
Fugl-Meyer Motor Upper Extremity Assessment
Description
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.
Time Frame
Baseline, 12 week, and 24 week retention
Secondary Outcome Measure Information:
Title
Motor Cortex Excitability Via Transcranial Magnetic Stimulation (TMS)
Time Frame
week 12
Title
Wolf Motor Function Test (WMFT)
Description
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.
Time Frame
Baseline, 12 week, and 24 week retention
Title
Stroke Impact Scale: Hand Subscale
Description
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.
Time Frame
Baseline, 12 week and 24 week retention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher T. Bever, MD
Organizational Affiliation
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
31328671
Citation
Conroy SS, Wittenberg GF, Krebs HI, Zhan M, Bever CT, Whitall J. Robot-Assisted Arm Training in Chronic Stroke: Addition of Transition-to-Task Practice. Neurorehabil Neural Repair. 2019 Sep;33(9):751-761. doi: 10.1177/1545968319862558. Epub 2019 Jul 22.
Results Reference
result
Learn more about this trial
Evaluation of Robot Assisted Neuro-Rehabilitation
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