Your session is about to expire
← Back to Search
Procedure
Robotic Rehabilitation for Stroke (Aim2&3 Trial)
N/A
Recruiting
Led By Li-Qun Zhang, Ph.D.
Research Sponsored by University of Maryland, Baltimore
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
First focal unilateral lesion, ischemic or hemorrhagic
Rated between stages 2-4 on the Chedoke McMaster Stroke Assessment Impairment Inventory: Stage of Recovery of the Arm and Hand
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 2 weeks prior to intervention, 2 weeks following intervention, and 2 months following intervention
Awards & highlights
Aim2&3 Trial Summary
This trial is testing whether specific treatments for different types of arm and hand impairments caused by stroke can improve movement.
Who is the study for?
This trial is for individuals who had their first stroke 1-12 months ago, can sit for 3 hours, and have an arm and hand recovery stage rated between 2-4. It's not suitable for those with severe pain or contracture in the upper extremity, apraxia, low mental status scores, recent Botox in the arm, or involvement in other gait/limb studies.Check my eligibility
What is being tested?
The study aims to assess and treat complex motor impairments of the arm and hand post-stroke. It will compare effects of different treatments: passive movement using a Hand robot or IntelliArm device versus passive stretching exercises on limb function recovery.See study design
What are the potential side effects?
Potential side effects may include discomfort from stretching or using rehabilitation devices. Overexertion could lead to muscle soreness or fatigue. The equipment used should be safe but might cause minor skin irritation where it contacts the body.
Aim2&3 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had one stroke, either from a clot or bleed.
Select...
My arm and hand recovery after stroke is rated between stages 2 to 4.
Aim2&3 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within 2 weeks prior to intervention, 2 weeks following intervention, and 2 months following intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 2 weeks prior to intervention, 2 weeks following intervention, and 2 months following intervention
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Changes from baseline Graded Wolf Motor Function Test (WMFT) at two time points
Secondary outcome measures
Changes from baseline Action Research Arm Test (ARAT) at two time points
Changes from baseline Chedoke McMaster Stroke Assessment: Impairment Inventory of Arm and Hand at two time points
Changes from baseline Fugl-Meyer Upper Extremity at two time points
+6 moreAim2&3 Trial Design
4Treatment groups
Experimental Treatment
Group I: The hand robot with passive stretchingExperimental Treatment2 Interventions
Groups are split into 2 conditions based on stretching and 2 conditions based on target of intervention (arm or hand). Subjects will complete up to 30 minutes of strong passive stretching, then followed by 45-60 minutes of active movement training with the hand robot.
Group II: The hand robot with passive movementExperimental Treatment2 Interventions
Groups are split into 2 conditions based on stretching and 2 conditions based on target of intervention (arm or hand). Subjects will wear the hand robot for up to 30 minutes with gentle passive movement or little stretching, then followed by 45-60 minutes of active movement training with the hand robot.
Group III: IntelliArm with passive stretchingExperimental Treatment2 Interventions
Groups are split into 2 conditions based on stretching and 2 conditions based on target of intervention (arm or hand). Subjects will complete up to 30 minutes of strong passive stretching, then followed by 45-60 minutes of active movement training with the IntelliArm.
Group IV: IntelliArm with passive movementExperimental Treatment2 Interventions
Groups are split into 2 conditions based on stretching and 2 conditions based on target of intervention (arm or hand). Subjects will wear the IntelliArm for up to 30 minutes with gentle passive movement or little stretching, then followed by 45-60 minutes of active movement training with the IntelliArm.
Find a Location
Who is running the clinical trial?
North Carolina State UniversityOTHER
33 Previous Clinical Trials
15,488 Total Patients Enrolled
5 Trials studying Stroke
232 Patients Enrolled for Stroke
University of Maryland, BaltimoreLead Sponsor
688 Previous Clinical Trials
374,584 Total Patients Enrolled
10 Trials studying Stroke
1,399 Patients Enrolled for Stroke
National Institute on Disability, Independent Living, and Rehabilitation ResearchFED
71 Previous Clinical Trials
9,057 Total Patients Enrolled
5 Trials studying Stroke
2,211 Patients Enrolled for Stroke
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I rate my shoulder pain as 7 or more out of 10.I have severe stiffness in my arm that limits movement.I have not had a Botox injection in my arm in the last 4 months.You have injuries in your muscles or bones that are not related to the condition being studied.I have had one stroke, either from a clot or bleed.I cannot sit in a chair for 3 hours straight.My arm and hand recovery after stroke is rated between stages 2 to 4.You are currently taking part in studies for walking or arm exercises.Difficulty with performing purposeful movements, even though the muscles are not weak.I had a stroke between 1 and 12 months ago.You scored less than 22 on a test that checks how well your brain is working.You do not fit well into the equipment needed for the study.
Research Study Groups:
This trial has the following groups:- Group 1: IntelliArm with passive movement
- Group 2: The hand robot with passive stretching
- Group 3: The hand robot with passive movement
- Group 4: IntelliArm with passive stretching
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 openings currently available for participation in the experiment?
"As per information on clinicaltrials.gov, this experiment is presently enrolling participants having been initially published in October 2018 and amended as recently as January 2022."
Answered by AI
Does the age of sixty or above constitute a disqualifying factor for this medical trial?
"Eligible candidates for this experiment must be under 85 years old, and at least 18 in age."
Answered by AI
Who can be admitted to partake in this research trial?
"To be eligible for this medical trial, potential participants must have experienced a stroke and fall between the age range of 18-85 years old. Ultimately, 72 individuals will take part in the study."
Answered by AI
How many participants have signed up for this scientific trial?
"Affirmative. Clinicaltrials.gov attests that the current recruitment drive begun on October 14, 2018 and was last revised January 24th 2022. This clinical trial is accepting 72 participants from one medical facility."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger