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Breathing Exercises for Stroke Recovery (AFAS Trial)

N/A
Recruiting
Led By Ann Van de Winckel, PhD, MS, PT
Research Sponsored by University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Left or right hemiplegia
People with stroke who are medically stable with one or more ischemic or hemorrhagic stroke(s)
Must not have
Adults lacking capacity to consent
Contractures in the tested arm that would hinder testing arm movements
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new intervention for anxiety that involves slow breathing. The sessions are 15 minutes long and completed with the help of an app. The study is ongoing and participants will undergo screening and fill out some questionnaires.

Who is the study for?
This trial is for adults aged 18-99 who have had a stroke and are medically stable. They must be able to attend one session, understand English (or work with a translator), and sign consent. People with severe cognitive issues, arm contractures that limit movement, or other medical conditions that interfere with participation cannot join.
What is being tested?
The study tests the effects of two breathing exercises on upper limb motor skills in stroke patients using an app called Breathe Deep. Participants try slow-breathing at 6 breaths/min and control breathing at 12 breaths/min in sessions two weeks apart to measure quality of movement and body awareness.
What are the potential side effects?
Breathing exercises are generally safe but may cause temporary discomfort like dizziness or shortness of breath due to the controlled breathing patterns required during the intervention.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have paralysis on one side of my body.
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I have had a stroke but am now medically stable.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am unable to make my own medical decisions.
Select...
I have stiff joints in my arm that limit its movement.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Reliability of a new scale for stroke: Awareness of Functional Tasks with Arm and Hand in Stroke (AFAS scale)
Validity a new motor scale for upper extremity Upper Limb Motor Scale in people with stroke (AFAS scale
Secondary study objectives
Motor Evaluation Scale for Upper Extremity in Stroke Patients (MESUPES)
Physical Body Experience Questionnaire (PBE)
Revised Body Awareness Rating Scale (REVBA)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Breathing ExerciseExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

University of MinnesotaLead Sponsor
1,423 Previous Clinical Trials
1,619,685 Total Patients Enrolled
38 Trials studying Stroke
50,803 Patients Enrolled for Stroke
Ann Van de Winckel, PhD, MS, PTPrincipal InvestigatorUniversity of Minnesota

Media Library

Breathing Exercise Clinical Trial Eligibility Overview. Trial Name: NCT03328468 — N/A
Stroke Research Study Groups: Breathing Exercise
Stroke Clinical Trial 2023: Breathing Exercise Highlights & Side Effects. Trial Name: NCT03328468 — N/A
Breathing Exercise 2023 Treatment Timeline for Medical Study. Trial Name: NCT03328468 — N/A
~13 spots leftby Nov 2025
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