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

Primary Purpose

Stroke

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Breathing Exercise
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Stroke focused on measuring Stroke

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of MinnesotaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Breathing Exercise

Arm Description

Outcomes

Primary Outcome Measures

Reliability of a new scale for stroke: Awareness of Functional Tasks with Arm and Hand in Stroke (AFAS scale)
AFAS contains 13 items
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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
October 19, 2017
Last Updated
February 17, 2023
Sponsor
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT03328468
Brief Title
Development of Upper Limb Motor Scale to Measure Quality of Movement and Body Awareness in Stroke
Acronym
AFAS
Official Title
Development of Upper Limb Motor Scale "Awareness of Functional Tasks With Arm and Hand in Stroke"
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 30, 2017 (Actual)
Primary Completion Date
October 1, 2024 (Anticipated)
Study Completion Date
October 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Breathing Exercise
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Breathing Exercise
Intervention Description
Breathing exercise for stroke patients
Primary Outcome Measure Information:
Title
Reliability of a new scale for stroke: Awareness of Functional Tasks with Arm and Hand in Stroke (AFAS scale)
Description
AFAS contains 13 items
Time Frame
Baseline
Title
Validity a new motor scale for upper extremity Upper Limb Motor Scale in people with stroke (AFAS scale
Description
Scale using 0-45 for measurement, 0 being low and 45 being high.
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Motor Evaluation Scale for Upper Extremity in Stroke Patients (MESUPES)
Description
Scale using 0-58 for measurement, 0 being low and 58 being high. Assesses qualities of the arm and hand.
Time Frame
Baseline
Title
Revised Body Awareness Rating Scale (REVBA)
Description
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.
Time Frame
Baseline
Title
Physical Body Experience Questionnaire (PBE)
Description
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.
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ann Van de Winckel, PhD, MS, PT
Phone
612-625-1191
Email
avandewi@umn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ann Van de Winckel, PhD, MS, PT
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ann Van de Winckel, PhD, MS, PT
Phone
612-625-1911
Email
avandewi@umn.edu
First Name & Middle Initial & Last Name & Degree
Ann Van de Winckel, PhD, MS, PT

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.med.umn.edu/rehabmedicine/research/motor-scale-awareness
Description
Related Info

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

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