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

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Other: Breathing Exercise

• Registration Number: NCT03328468
• Lead Sponsor: University of Minnesota

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.

Study Timeline

• Study First Submitted: 2017-10-19
• Study First Submitted QC: 2017-10-27
• Study First Posted: 2017-11-01
• Study Start: 2017-12-30
• Primary Completion: 2024-10-01
• Study Completion: 2024-10-01
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-20
• Last Update Posted: 2024-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Breathing Exercise	Breathing Exercise	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Physical Body Experience Questionnaire (PBE)	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.
Motor Evaluation Scale for Upper Extremity in Stroke Patients (MESUPES)	Baseline	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)	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.

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States