There is one clinical trial.
After stroke, the combination of progressive skills practice in an adequate dose, exercise for fitness, and reduced sedentary time will augment motor and cognitive outcomes. Sensorimotor and cognitive improvements after stroke often reach a general plateau by approximately 12 weeks after onset, however. Drugs that might enhance learning or neural repair, as well as other molecular and synaptic adaptations that occur during skills training and fitness exercise, might extend that recovery curve, although to date only fluoxetine has given any hint of this. Most trials have tested agents that modulate neurotransmitters. Several very recent preclinical experiments and observational studies in patients after stroke suggest that the commercially available medication, Maraviroc, a CCR5 antagonist, may augment skills learning during rehabilitation training, especially during the first three months after onset, by affecting CREB and synaptic plasticity. The investigators will carry out a randomized controlled trial of Maraviroc in patients with disabilities severe enough to have required inpatient stroke rehabilitation and, based on our preclinical data, who can start the drug intervention within 6 weeks of stroke onset. The investigators will compare usual post-stroke care plus placebo versus Maraviroc given for 8 weeks in 60 participants. However, to try to maximize the amount of practice that is most relevant to the primary outcome measurements and determine whether or not Maraviroc can enhance the effects of training, as hypothesized, all participants will be tele-monitored by mobile health devices and will receive weekly telephonic encouragement, based on device data, to walk, reduce sedentary time, and reach and grasp in the home in between usual care therapies. Compliance, serial motor changes over time, and self-management skills in making use of the telerehabilitation devices will be a nested substudy of feasibility of remote monitoring and feedback.
About 15% of the Ashkenazi Jewish population carries the deletion (CCR5 rs333 - 32).
Description: Timed walking speed over 10 meters. The evaluable sample size of 30 in each group will have 80% power to detect a difference in means of -0.206 (m/s), the difference between an assumed usual care walking speed of 0.51 (SD=0.28) and an assumed intervention group mean walking speed of 0.716. This assumes a common standard deviation in the two groups and a two group t-test with a 0.05 two-sided significance level. The estimates for the mean and standard deviation for walking speed come from the LEAPS RCT (Duncan, N Engl J Med, 2011). The t-test used for the power calculation is a simplification of the mixed effects analysis plan for the primary endpoints.Measure: 10 Meter Walk Test Time: Baseline, 6 months post
Description: Assessment of upper extremity function. Our sample size of 30 for each group is based on a statistical power of 80% with an alpha of 5% for detecting a meaningful difference of 6 points, i.e., a 10% change, which has been suggested by several completed trials. In a stroke trial, the standard deviation was 8 points measured at 2 weeks post stroke.Measure: Action Research Arm Test Time: Baseline, 6 months post
Description: Assessment of arm and leg impairment after strokeMeasure: Fugl-Meyer Motor score Time: Baseline, within 5 days of last medication dose (8 weeks), at 6 months post stroke
Description: Self-report questionnaire on quality of life post-strokeMeasure: Stroke Impact Scale Time: Baseline, within 5 days of last medication dose (8 weeks), at 6 months post stroke
Description: Distance walked in a 6 minute time periodMeasure: 6 minute walking distance Time: Baseline, within 5 days of last medication dose (8 weeks), at 6 months post stroke
Description: Self-report questionnaire related to exercise enjoymentMeasure: Physical Activity Enjoyment Scale Time: Baseline, within 5 days of last medication dose (8 weeks), at 6 months post stroke
Description: Self-report questionnaire related to confidence in increasing activity and maintaining exercise routinesMeasure: Activity Self Efficacy Time: Baseline, within 5 days of last medication dose (8 weeks), at 6 months post stroke
Description: Self-report of activity levelsMeasure: International Physical Activity Questionnaire Time: Baseline, within 5 days of last medication dose (8 weeks), at 6 months post stroke
Description: Sedentary timeMeasure: Walking activity, Sensors Time: Collected daily for 8 weeks
Description: Amount of time practicingMeasure: Upper extremity practice, Sensors Time: Collected daily for 8 weeks
Description: Repetitions of task practiceMeasure: Upper extremity practice, Sensors Time: Collected daily for 8 weeks