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Exercise and Rehabilitation for Stroke
Phase < 1
Recruiting
Led By Ryan E Ross, PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
50-90 years of age
Box & Block test score of at least 3 blocks in 60 seconds with the affected arm
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 8 weeks
Awards & highlights
Study Summary
This trial will examine the effect of combining aerobic exercise with physical rehabilitation on physical and mental function in stroke survivors in order to improve care for Veterans.
Who is the study for?
This trial is for stroke survivors aged 50-90 who had a unilateral stroke at least 6 months ago, can communicate, and have moderate arm movement impairment. They must pass an exercise test and have some ability to move the affected arm. Excluded are those with certain medical conditions like severe heart issues, other neurological diseases, severe cognitive impairments or vision problems that affect reaching.Check my eligibility
What is being tested?
The study tests if combining aerobic exercise (AEx) with physical rehabilitation improves physical and mental functions in stroke survivors. It explores whether AEx before rehab makes the brain more responsive to treatment, potentially enhancing recovery outcomes.See study design
What are the potential side effects?
While not explicitly listed in the provided information, typical side effects of aerobic exercises may include muscle soreness, fatigue, and increased heart rate. Physical rehabilitation might cause temporary discomfort or pain in the affected limbs.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 50 and 90 years old.
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I can move at least 3 blocks in a minute with my affected arm.
Select...
I can lift my arm slightly and straighten my elbow a bit.
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I can move my affected arm and hand nearly as well as before.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 8 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from baseline upper extremity impairment assessed by the Fugl Meyer Upper Extremity Assessment (FMA-UE)
Secondary outcome measures
Cognition
Change from baseline depressive symptoms assessed by the Geriatric Depression Scale (GDS)
Change from baseline health related quality of life assessed by the Stroke Impact Scale (SIS)
+4 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Stretching (CON) + upper extremity rehabilitationExperimental Treatment2 Interventions
Subjects will perform 15 minutes of lower extremity stretching. Following lower extremity stretching subjects will receive 200 repetitions of DDP.
Group II: Aerobic exercise (AEx) + upper extremity rehabilitationExperimental Treatment2 Interventions
Subject will receive a total of 24 intervention sessions. In each session, subjects will perform 15 minutes of AEx followed by 200 repetitions of an upper extremity rehabilitation program.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aerobic exercise
2000
Completed Phase 2
~1130
Lower extremity stretching
2022
N/A
~30
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,610 Previous Clinical Trials
3,305,144 Total Patients Enrolled
83 Trials studying Stroke
6,678 Patients Enrolled for Stroke
Ryan E Ross, PhDPrincipal InvestigatorRalph H. Johnson VA Medical Center, Charleston, SC
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have moderate difficulty moving my arm.I am between 50 and 90 years old.I have pain in my weak arm that stops me from reaching out.I have severe difficulty speaking or understanding speech.Your UBACC score is less than 15.I can move at least 3 blocks in a minute with my affected arm.I can lift my arm slightly and straighten my elbow a bit.I have a neurological condition that affects my ability to learn new physical tasks.I had a stroke on one side of my brain more than 6 months ago.I can move my affected arm and hand nearly as well as before.My blood pressure is very high, over 200/110 mmHg.I have COPD or need oxygen.I have had a blood clot in my leg or lung in the past 6 months.You have trouble understanding or following simple instructions.You have significant problems with memory and thinking.I have diabetes with recent weight loss, diabetic coma, or frequent insulin reactions.I do not have electronic implants, a history of seizures, and am not a woman able to have children.I have a condition or vision problem that affects my ability to reach.I have a lesion in my brainstem or cerebellum.You can finish and pass a physical fitness test.I have a history of serious heart conditions.
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.
How many participants are eligible for this experiment?
"Affirmative. Clinicaltrials.gov notes that this medical trial, which was first posted on July 1st 2021, is currently searching for 40 volunteers from 1 different centre. The information has been most recently updated on June 15th 2022."
Answered by AI
Are there still opportunities for individuals to be part of this research?
"As indicated on clinicaltrials.gov, this medical trial remains open to participants. The listing was first made available on July 1st 2021 and the details have been most recently updated June 15th 2022."
Answered by AI
Is it feasible for me to join this clinical experiment?
"In order to become a part of this medical trial, individuals who have experienced stroke and are aged between 50 and 90 years old may be eligible. This experiment is in search for 40 participants in total."
Answered by AI
To what extent are individuals aged 35 or younger accepted into this clinical research?
"This investigation necessitates that enrollees must be between 50 and 90 years of age. There are 37 studies dedicated to those younger than 18 while 1006 exist for seniors over 65."
Answered by AI
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