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

NCT03328468 | Completed DMC

• 1 other identifier: PMR-2017-25877
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Stroke

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Motor Evaluation Scale for Upper Extremity in Stroke Patients (MESUPES)

  Baseline

• Revised Body Awareness Rating Scale (REVBA)

  Baseline

• Physical Body Experience Questionnaire (PBE)

  Baseline

Study Arms (1)

Breathing Exercise

EXPERIMENTAL

Other: Breathing Exercise

Interventions

Breathing Exercise OTHER

Breathing exercise for stroke patients

Breathing Exercise

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Stroke

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Ann Van de Winckel, PhD, MS, PT

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2017
• First Posted: November 1, 2017
• Study Start: December 30, 2017
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: November 22, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)