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Behavioural Intervention
Occupational Therapy Exercises for Chronic Stroke
N/A
Recruiting
Led By Sean Savitz, MD
Research Sponsored by The University of Texas Health Science Center, Houston
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 baseline, month 4, month 8, month 12, month 16, month 20, month 24
Awards & highlights
Study Summary
This trial looks at how exercise affects arm movement in people with chronic stroke. #strokerehab
Who is the study for?
This trial is for chronic stroke survivors at least one month post-stroke, with a confirmed stroke event by CT or MRI. Participants must have some wrist movement and be able to follow instructions. Excluded are those with prior significant arm issues, other brain conditions, substance abuse history, dementia, severe pre-stroke disability, seizures, previous strokes causing arm weakness, pregnancy or contraindications to MRI/TMS.Check my eligibility
What is being tested?
The study aims to compare the effectiveness of a standard occupational therapy exercise program on improving arm function in individuals who have had a stroke. The focus is on assessing long-term outcomes using various investigational methods following the prescribed exercises.See study design
What are the potential side effects?
Since this trial involves an exercise program rather than medication or invasive procedures, side effects may include muscle soreness or fatigue related to physical activity but are generally expected to be minimal.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, month 4, month 8, month 12, month 16, month 20, month 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, month 4, month 8, month 12, month 16, month 20, month 24
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
change in arm impairment as assessed by Fugl Meyer - Upper Extremity assessment
Secondary outcome measures
Change in integrity of corticospinal tract fibers as assessed by MRI with Diffusion Tensor Imaging (DTI).
Change in motor evoked potential as assessed by Transcranial Magnetic Stimulation
Trial Design
1Treatment groups
Experimental Treatment
Group I: ARM-programExperimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
The University of Texas Health Science Center, HoustonLead Sponsor
904 Previous Clinical Trials
320,950 Total Patients Enrolled
42 Trials studying Stroke
7,397 Patients Enrolled for Stroke
Sean Savitz, MDPrincipal InvestigatorUTHealth Houston
5 Previous Clinical Trials
320 Total Patients Enrolled
5 Trials studying Stroke
320 Patients Enrolled for Stroke
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an arm injury that limits my movement or causes significant pain.I can move my wrist well enough to use a robotic device.You should not have an MRI or Transcranial Magnetic Stimulation (TMS) for medical reasons.You have had a stroke confirmed by a CT or MRI.It has been over a month since my last stroke.I have a history of seizures or epilepsy.I was significantly independent before my stroke.I do not have brain cancer or conditions like multiple sclerosis.You have a history of using a lot of drugs or alcohol.I have been diagnosed with dementia.I have had a stroke before that caused arm weakness or injury.
Research Study Groups:
This trial has the following groups:- Group 1: ARM-program
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.
Stroke Patient Testimony for trial: Trial Name: NCT05659875 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are those below the age of 40 admissible to this research endeavor?
"This project is enrolling adults aged 18 to 80."
Answered by AI
How many participants are enrolled in this research endeavor?
"Affirmative, the clinical trial is actively searching for participants. It was initially posted online on September 8th 2022 and last edited December 12th 2022. The research requires ten patients from a single medical centre to take part."
Answered by AI
Is there availability to join this trial for those interested?
"Affirmative. Clinicaltrials.gov attests that this medical trial, initially posted on September 8th 2022, is actively seeking participants. 10 patients are needed to complete the study at one clinical site."
Answered by AI
Who fulfills the requirements for participation in this experiment?
"This trial is in search of 10 stroke survivors aged 18-80 who meet the following qualifications: 1 month post-stroke, confirmation of single qualifying stroke event through CT or MRI scans, Manual Muscle Test score of 2/5 for wrist flexors and extensors (to ensure ability to use robotic device), capacity to comprehend written instructions."
Answered by AI
Who else is applying?
What state do they live in?
Texas
What site did they apply to?
The University of Texas Health Science Center at Houston
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I am looking for additional resources and interventions to support my stroke recovery.
PatientReceived no prior treatments
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