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

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

Study Overview

• Status: Recruiting
• Conditions: Stroke
• Intervention / Treatment: Other: Breathing Exercise

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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ann Van de Winckel, PhD, MS, PT; Phone Number: 612-625-1191; Email: avandewi@umn.edu

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Recruiting
      • University of Minnesota
      • Contact: Ann Van de Winckel, PhD, MS, PT; Phone Number: 612-625-1911; Email: avandewi@umn.edu
      • Principal Investigator: Ann Van de Winckel, PhD, MS, PT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Breathing Exercise	Other: Breathing Exercise; Breathing exercise for stroke patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reliability of a new scale for stroke: Awareness of Functional Tasks with Arm and Hand in Stroke (AFAS scale)	AFAS contains 13 items	Baseline
Validity a new motor scale for upper extremity Upper Limb Motor Scale in people with stroke (AFAS scale	Scale using 0-45 for measurement, 0 being low and 45 being high.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Motor Evaluation Scale for Upper Extremity in Stroke Patients (MESUPES)	Scale using 0-58 for measurement, 0 being low and 58 being high. Assesses qualities of the arm and hand.	Baseline
Revised Body Awareness Rating Scale (REVBA)	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.	Baseline
Physical Body Experience Questionnaire (PBE)	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.	Baseline

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Ann Van de Winckel, PhD, MS, PT, University of Minnesota

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): December 30, 2017
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: October 19, 2017
• First Submitted That Met QC Criteria: October 27, 2017
• First Posted (Actual): November 1, 2017

Study Record Updates

• Last Update Posted (Estimated): March 1, 2024
• Last Update Submitted That Met QC Criteria: February 28, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Stroke
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: PMR-2017-25877

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No