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Completed

NCT Number: NCT03328468

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

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Breathing exercise

Other

Breathing exercise for stroke patients

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

Development of Upper Limb Motor Scale "Awareness of Functional Tasks With Arm and Hand in Stroke"

Acronym: AFAS

Important dates

Study start
2017
Primary completion
2024
Study completion
2024
First posted
Nov 1, 2017
Registry last updated
Nov 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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