Clinical trial NCT03328468: Development of Upper Limb Motor Scale to Measure Quality of Movement and Body Awareness in Stroke
Official title: Development of Upper Limb Motor Scale "Awareness of Functional Tasks With Arm and Hand in Stroke"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Stroke
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2017-11-01
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Reliability of a new scale for stroke: Awareness of Functional Tasks with Arm and Hand in Stroke (AFAS scale)
timeFrame: Baseline
measure: Validity a new motor scale for upper extremity Upper Limb Motor Scale in people with stroke (AFAS scale
timeFrame: Baseline
Secondary outcomes:
measure: Motor Evaluation Scale for Upper Extremity in Stroke Patients (MESUPES)
timeFrame: Baseline
measure: Revised Body Awareness Rating Scale (REVBA)
timeFrame: Baseline
measure: Physical Body Experience Questionnaire (PBE)
timeFrame: Baseline
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Ann Van de Winckel, PhD, MS, PT
role: PRINCIPAL_INVESTIGATOR
References: