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

Stroke Clinical Trial

— AFAS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03328468
• Other study ID #: PMR-2017-25877
• Status: Recruiting
• Phase: N/A
• Start date: December 30, 2017
• Est. completion date: October 1, 2024

Study information

• Verified date: February 2024
• Source: University of Minnesota
• Contact: Ann Van de Winckel, PhD, MS, PT
• Phone: 612-625-1191
• Email: avandewi[@]umn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 1, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Breathing Exercise
Breathing exercise for stroke patients

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reliability of a new scale for stroke: Awareness of Functional Tasks with Arm and Hand in Stroke (AFAS scale)	AFAS contains 13 items	Baseline
Primary	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	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
Secondary	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
Secondary	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

External Links

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