Evaluation of Robot Assisted Neuro-Rehabilitation (SRT3)
|ClinicalTrials.gov Identifier: NCT01253018|
Recruitment Status : Completed
First Posted : December 3, 2010
Results First Posted : January 7, 2016
Last Update Posted : March 1, 2016
|Condition or disease||Intervention/treatment||Phase|
|Stroke||Behavioral: Robot Therapy Behavioral: Transition to Task Training||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||59 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Evaluation of Robot Assisted Neuro-rehabilitation|
|Study Start Date :||April 2011|
|Actual Primary Completion Date :||January 2015|
|Actual Study Completion Date :||January 2015|
Experimental: Robot Therapy
12 weeks of robotic therapy
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
Active Comparator: Transition to Task Training
12 weeks of task specific practice combined with robotic therapy
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.
- Fugl-Meyer Motor Upper Extremity Assessment [ Time Frame: Baseline, 12 week, and 24 week retention ]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.
- Motor Cortex Excitability Via Transcranial Magnetic Stimulation (TMS) [ Time Frame: week 12 ]
- Wolf Motor Function Test (WMFT) [ Time Frame: Baseline, 12 week, and 24 week retention ]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 ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01253018
|United States, Maryland|
|Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD|
|Baltimore, Maryland, United States, 21201|
|Principal Investigator:||Christopher Bever, MD||Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD|