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Behavioural Intervention
Combined Exercise and Therapy for Post-Stroke Reading Deficits
N/A
Recruiting
Led By Olga Boukrina
Research Sponsored by Kessler Foundation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
1st ever stroke
More than 3 months post-stroke
Must not have
Prior neurological disease
Concurrent speech and language therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and within 2 weeks of treatment completion (~10 weeks from study onset)
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to test a new way of treating reading disorders caused by stroke. It will combine exercise training with a specific reading treatment to help improve blood flow in the brain and strengthen the damaged neural networks
Who is the study for?
This trial is for right-handed individuals who were fluent in English and literate before their first-ever stroke, which occurred over 3 months ago. They must have reading deficits as defined by specific accuracy percentages for words and nonwords, be cleared for exercise by a physician, and live within 50 miles of the Kessler Foundation. People with MRI contraindications, prior neurological diseases, or those currently undergoing speech therapy cannot participate.
What is being tested?
The study tests a new treatment method combining physical exercises (stretching and aerobic training) with Phono-Motor Therapy to improve reading abilities after a stroke. The goal is to boost brain circulation and repair damaged language networks through this dual approach.
What are the potential side effects?
While the trial's description does not specify side effects, typical ones from exercise may include muscle soreness or fatigue. Phono-Motor Therapy generally doesn't have physical side effects but can sometimes cause frustration or mental fatigue.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had my first stroke.
Select...
It has been over 3 months since I had a stroke.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had a neurological disease before.
Select...
I am currently receiving speech and language therapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and within 2 weeks of treatment completion (~10 weeks from study onset)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and within 2 weeks of treatment completion (~10 weeks from study onset)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
2 Alternative Forced Choice Computer Tasks
Cerebral Blood Flow (CBF)
Reading Aloud
+3 moreSecondary study objectives
Philadelphia Naming Test (Short)
Western Aphasia Battery Revised
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Aerobic Exercise Treatment (AET) combined with Phono-Motor Therapy (PMT)Experimental Treatment2 Interventions
Patients will receive 40, once-daily 2-hour intervention sessions administered 4-5 times per week by trained research assistants. Sessions will begin with a 5-min warm-up, followed by 20 min of aerobic exercise (cycling, 60% heart rate range), and a 5-min cool-down. Participants will rate their perceived effort every 5 minutes and complete a log at the end of each session to characterize their experience. When HR returns to near resting levels (i.e., 5-min after cool-down), participants will undertake the PMT for the remaining 90 min.
Group II: Stretching and PMTActive Control2 Interventions
Patients will receive 40, once-daily 2-hour intervention sessions administered 4-5 times per week by trained research assistants. Sessions will begin with a 5-min warm-up, followed by 20 min of stretching and a 5-min cool-down. Stretching activities will target the head/neck, shoulder, elbow/forearm, hand/wrist, trunk/hip, ankle/foot. Participants will complete a log at the end of each session to characterize their experience, and within 5 min of completing the last stretching activity, participants will undertake PMT for the remaining 90 min of a given session.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aerobic Exercise Training (AET)
2015
N/A
~50
Find a Location
Who is running the clinical trial?
Kessler FoundationLead Sponsor
182 Previous Clinical Trials
11,023 Total Patients Enrolled
Olga BoukrinaPrincipal InvestigatorKessler Foundation
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