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Robotic Therapy
Early Robotic Rehab Low Intensity for Stroke (RESTORE Trial)
N/A
Waitlist Available
Led By Sean Dukelow, MD, PhD
Research Sponsored by University of Calgary
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to 180 days
Awards & highlights
RESTORE Trial Summary
This trial is investigating whether earlier and more intense robotic therapy is more effective for stroke patients.
RESTORE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline to 180 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to 180 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Fugl-Meyer upper extremity motor function score (FMA)
Secondary outcome measures
Action Research Arm Test (ARAT)
Functional Independence Measure (FIM)
Robotic Assessments
+1 moreRESTORE Trial Design
5Treatment groups
Active Control
Group I: Early Robotic Rehab Low IntensityActive Control1 Intervention
This group will begin robotic rehabilitation using a robotic exoskeleton between days 5-9 after their stroke. They will receive one hour of treatment per day for 20 days.
Group II: Early Robotic Rehab High IntensityActive Control1 Intervention
This group will begin robotic rehabilitation using a robotic exoskeleton between days 5-9 after their stroke. They will receive 2 one-hour treatment sessions per day for 20 days.
Group III: Late Robotic Rehab Low IntensityActive Control1 Intervention
This group will begin robotic rehabilitation using a robotic exoskeleton between days 21-25 after their stroke. They will receive one hour of treatment per day for 20 days.
Group IV: Late Robotic Rehab High IntensityActive Control1 Intervention
This group will begin robotic rehabilitation using a robotic exoskeleton between days 21-25 after their stroke. They will receive 2 one-hour treatment sessions per day for 20 days.
Group V: Control GroupActive Control1 Intervention
This group will receive usual care with robotic assessment.
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Who is running the clinical trial?
University of CalgaryLead Sponsor
792 Previous Clinical Trials
869,022 Total Patients Enrolled
33 Trials studying Stroke
40,203 Patients Enrolled for Stroke
Queen's UniversityOTHER
365 Previous Clinical Trials
120,285 Total Patients Enrolled
4 Trials studying Stroke
1,030 Patients Enrolled for Stroke
Sean Dukelow, MD, PhDPrincipal InvestigatorUniversity of Calgary
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a history of stroke or a serious neurological condition like Multiple Sclerosis.You have an existing muscle or bone injury that could impact your ability to participate in the study's therapy.You had a stroke (either bleeding or blockage in the brain) recently.You are participating in another clinical trial at the same time.
Research Study Groups:
This trial has the following groups:- Group 1: Early Robotic Rehab Low Intensity
- Group 2: Early Robotic Rehab High Intensity
- Group 3: Late Robotic Rehab Low Intensity
- Group 4: Late Robotic Rehab High Intensity
- Group 5: Control Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any opportunities presently available for patients to participate in this trial?
"Affirmative. According to the clinicaltrials.gov database, this medical experiment is currently recruiting participants who can be found at one location. This project was initially posted on May 1st 2019 and revised recently on December 19th of that same year; altogether 132 patients are needed for inclusion in the trial."
Answered by AI
How many subjects are participating in this clinical trial?
"Affirmative. The clinicaltrials.gov database reports that this research endeavour, initially posted on May 1st 2019, is still actively seeking volunteers for the study. 132 participants must be enrolled from a single location."
Answered by AI
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