Development of Upper Limb Motor Scale to Measure Quality of Movement and Body Awareness in Stroke (AFAS)
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|ClinicalTrials.gov Identifier: NCT03328468|
Recruitment Status : Recruiting
First Posted : November 1, 2017
Last Update Posted : February 11, 2022
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.
|Condition or disease||Intervention/treatment||Phase|
|Stroke||Other: Breathing Exercise||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Development of Upper Limb Motor Scale "Awareness of Functional Tasks With Arm and Hand in Stroke"|
|Actual Study Start Date :||December 30, 2017|
|Estimated Primary Completion Date :||October 1, 2024|
|Estimated Study Completion Date :||October 1, 2024|
|Experimental: Breathing Exercise||
Other: Breathing Exercise
Breathing exercise for stroke patients
- Reliability of a new scale for stroke: Awareness of Functional Tasks with Arm and Hand in Stroke (AFAS scale) [ Time Frame: Baseline ]AFAS contains 13 items
- Validity a new motor scale for upper extremity Upper Limb Motor Scale in people with stroke (AFAS scale [ Time Frame: Baseline ]Scale using 0-45 for measurement, 0 being low and 45 being high.
- Motor Evaluation Scale for Upper Extremity in Stroke Patients (MESUPES) [ Time Frame: 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) [ Time Frame: 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.
- Physical Body Experience Questionnaire (PBE) [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03328468
|Contact: Ann Van de Winckel, PhD, MS, PTemail@example.com|
|United States, Minnesota|
|University of Minnesota||Recruiting|
|Minneapolis, Minnesota, United States, 55455|
|Contact: Ann Van de Winckel, PhD, MS, PT 612-625-1911 firstname.lastname@example.org|
|Principal Investigator: Ann Van de Winckel, PhD, MS, PT|
|Principal Investigator:||Ann Van de Winckel, PhD, MS, PT||University of Minnesota|