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Development of Upper Limb Motor Scale to Measure Quality of Movement and Body Awareness in Stroke (AFAS)

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ClinicalTrials.gov Identifier: NCT03328468
Recruitment Status : Recruiting
First Posted : November 1, 2017
Last Update Posted : February 21, 2023
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

Study Description
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Brief Summary:

For the breathing intervention, participants completed two experimental sessions at least two weeks apart. The experimental sessions were randomized between the slow-breathing condition (6 breaths/min) or the control breathing condition (12 breaths/min). Breathing interventions were 15 minutes in length and completed with the assistance of the breathing app, Breathe Deep (Mineev, Bizi Apps LLC).

The breathing intervention is currently completed.

The reliability and validity study of AFAS is ongoing. This is a one-time visit for participants in which participants will undergo screening of sensation and movement as well as fill in some questionnaires.


Condition or disease Intervention/treatment Phase
Stroke Other: Breathing Exercise Not Applicable

Detailed Description:

All participants had two visits for the breathing exercise. The only planned intervention was the breathing exercise, which is now concluded.

The protocol for the breathing intervention was as follows: The breathing protocol lasted 15 minutes. It was a guided breathing awareness session with a registered nurse (PhD student) who is also trained in integrative therapies and yoga instruction.

In parallel, during one of the visits the reliability and validity of a new scale for stroke to measure quality of movement and body awareness is tested.

This part is still ongoing and thus this becomes a one-time visit.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Development of Upper Limb Motor Scale "Awareness of Functional Tasks With Arm and Hand in Stroke"
Actual Study Start Date : December 30, 2017
Estimated Primary Completion Date : October 1, 2024
Estimated Study Completion Date : October 1, 2024
Arms and Interventions
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Arm Intervention/treatment
Experimental: Breathing Exercise Other: Breathing Exercise
Breathing exercise for stroke patients


Outcome Measures
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Primary Outcome Measures :
  1. Reliability of a new scale for stroke: Awareness of Functional Tasks with Arm and Hand in Stroke (AFAS scale) [ Time Frame: Baseline ]
    AFAS contains 13 items

  2. Validity a new motor scale for upper extremity Upper Limb Motor Scale in people with stroke (AFAS scale [ Time Frame: Baseline ]
    Scale using 0-45 for measurement, 0 being low and 45 being high.


Secondary Outcome Measures :
  1. Motor Evaluation Scale for Upper Extremity in Stroke Patients (MESUPES) [ Time Frame: Baseline ]
    Scale using 0-58 for measurement, 0 being low and 58 being high. Assesses qualities of the arm and hand.

  2. Revised Body Awareness Rating Scale (REVBA) [ Time Frame: Baseline ]
    The Revised Body Awareness Rating Scales contains 12 items rated on a 4-point scale. Total scores range from 0 to 36 with lower scores indicating better body awareness.

  3. Physical Body Experience Questionnaire (PBE) [ Time Frame: Baseline ]
    The Physical Body Experience Questionnaire contains 12 items, rated on a 7-point Likert scale. Total scores range from 0 to 48 with lower scores indicated better physical body experience.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Females and males ages 18-99 years of age
  • People with stroke who are medically stable with one or more ischemic or
  • hemorrhagic stroke(s)
  • left or right hemiplegia
  • willing and able to attend a one-time behavioral testing session
  • willing and able to sign consent to participate
  • able to hear, read and comprehend instructions given during the study
  • English speaking (or willing to work with a (student) translator)

Exclusion Criteria:

  • cognitive impairment (Mini-mental State Exam-brief version, <13/16)
  • contractures in the tested arm that would hinder testing arm movements
  • adults lacking capacity to consent
  • severe neglect, aphasia, apraxia
  • other medical conditions that preclude participation
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03328468


Contacts
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Contact: Ann Van de Winckel, PhD, MS, PT 612-625-1191 avandewi@umn.edu

Locations
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United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Ann Van de Winckel, PhD, MS, PT    612-625-1911    avandewi@umn.edu   
Principal Investigator: Ann Van de Winckel, PhD, MS, PT         
Sponsors and Collaborators
University of Minnesota
Investigators
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Principal Investigator: Ann Van de Winckel, PhD, MS, PT University of Minnesota
More Information
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Additional Information:

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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT03328468    
Other Study ID Numbers: PMR-2017-25877
First Posted: November 1, 2017    Key Record Dates
Last Update Posted: February 21, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Minnesota:
Stroke
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases