RecruitingPhase 2NCT04789616

The Canadian Maraviroc Randomized Controlled Trial To Augment Rehabilitation Outcomes After Stroke

The CAMAROS Trial: The Canadian Maraviroc Randomized Controlled Trial To Augment Rehabilitation Outcomes After Stroke

Sponsor

University of Calgary

Enrollment

120 participants

Start Date

Sep 15, 2022

Study Type

INTERVENTIONAL

Conditions

Stroke

Summary

The CAMAROS trial is a randomized controlled phase II trial analyzing the effect of coupling a C-C chemokine receptor 5 (CCR5) antagonist, Maraviroc (Celsentri), and exercise to improve both upper and lower extremity recovery after a stroke.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Activity Sensor, a behavioral approach called Exercise Program, and others for people with stroke. The study is currently recruiting participants at 6 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMaraviroc

Half of the participants will take maraviroc for a period of 8 weeks.

BEHAVIORALExercise Program

All participants will take part in an 8-week exercise program. While in-hospital, participants will undergo standard of care rehabilitation (estimated at 45 minutes each daily for physiotherapy \& occupational therapy) plus a supplementary upper extremity exercise program (Graded Repetitive Arm Supplementary Program (GRASP); estimated at 1 hour daily). After discharge from inpatient care, participants will complete an at-home supplementary upper and lower extremity exercise program. This program will include 30 minutes daily walking or sit-to-stand exercises and 30 minutes daily practice using the GRASP program.

OTHERPlacebo

Half of the participants will take a placebo for a period of 8 weeks.

DEVICEActivity Sensor

Participants will be asked to wear small activity sensors (one on each wrist and one on each ankle, total of four sensors) at the baseline, 4-week, 8-week, and 6-month assessments for 7 consecutive days. Activity related to walking, sleep, physical activity, and arm and leg movement throughout the day will be measured. The sensors will be worn for a total of 28 days throughout the study.

BEHAVIORALMotor Learning

Participants will be asked to perform a computer-based motor learning assessment at the baseline, 4-week, 8-week, and 6-month assessments. A retention task, which involves shorter versions of the initial tasks, will also be completed within 72 hours of the initial assessment (initial test and retention test).