Predictors of Response in Chronic Stroke (SRT5)
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|ClinicalTrials.gov Identifier: NCT04283253|
Recruitment Status : Completed
First Posted : February 25, 2020
Last Update Posted : October 8, 2020
|Condition or disease||Intervention/treatment||Phase|
|Stroke Brain Diseases Central Nervous System Diseases Nervous System Diseases Cardiovascular Diseases||Device: Robot + TTT exercise||Not Applicable|
After informed consent, a baseline neurological exam, medical records review, MRI of the brain, TMS, questionnaires, cognitive testing, robot evaluations, and arm function testing will occur. Baseline testing will occur in the first 4-6 weeks of participation including two separate sessions approximately 1 week a part to examine arm strength, range of motion, and ability to perform functional tasks, with one additional session if needed to verify stability between results. Additionally, one robot evaluation will be completed.
The intervention phase consists of 12 weeks of robot and transition to task arm exercise training (TTT). Interventions will occur approximately 3 times per week for 12 weeks for a total of 36 visits. Additional time and visits will be allowed with visits occurring 4 times per week or up to 6 additional weeks (not to exceed 18 weeks) if scheduling conflicts arise. The intervention sessions will be one hour in duration.
During the hour-long intervention, 45 minutes of robotic intervention will be followed by 15 minutes of TTT. The training will be sequential with 12 sessions focused on the wrist, followed by 12 sessions on the shoulder-elbow and the final 12 sessions alternating between the wrist and elbow-shoulder.
After the final training session, subjects will return after a 12 week retention period. At various time points during and after the intervention phase there will be additional arm function testing, robot evaluations, questionnaires, MRI and TMS sessions for re-assessment.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||One-arm, multiple baseline sequential, cohort study|
|Masking:||None (Open Label)|
|Official Title:||Neurophysiological and Kinematic Predictors of Response in Chronic Stroke|
|Actual Study Start Date :||October 22, 2019|
|Actual Primary Completion Date :||March 31, 2020|
|Actual Study Completion Date :||March 31, 2020|
Experimental: Robot + TTT Exercise
All participants will be enrolled in this group to receive the same 60 minute study intervention consisting of wrist and shoulder-elbow robot training and TTT arm exercises.
Device: Robot + TTT exercise
The intervention will be completed 36 visits approximately 3x/week for 12-18 weeks. The training progression will be sequential with 12 visits completed on the wrist robot, followed by 12 visits on the shoulder-elbow robot and completing with 12 visits alternating sessions on the wrist and shoulder-elbow robot. Participants will perform robot training for 45 minutes with each robot followed by 15 minutes of TTT practice to complete their 60 minute intervention session.
- A change in the Fugl-Meyer Upper Extremity Assessment score [ Time Frame: Immediately following the 12-week intervention ]The Fugl-Meyer is one of the primary outcome measures assessing change in arm use from baseline testing to mid-training after visits 12 and 24, and post-training after visit 36 and the 12 week retention period. It 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.
- A change in motor evoked potential during Transcranial Magnetic Stimulation of the motor cortex [ Time Frame: Immediately following the 12-week intervention ]TMS stimulation of the motor cortex will be performed using MagStim 200 Magnetic Stimulators (MagStim Ltd., Wales, UK) to assess change in the motor evoked potential (MEP) of the arm muscles.
- A change in brain connections assessed via MRI of the brain [ Time Frame: Immediately following the 12-week intervention ]A detailed analysis of the MRI data will examine individual interregional connections to determine whether any of them are more sensitive to the intervention than others.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04283253
|United States, Pennsylvania|
|VA Pittsburgh Healthcare System|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||George Wittenberg, PhD||University of Pittsburgh|