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

NCT ID: NCT03328468

Last Updated: 2024-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-30

Study Completion Date

2024-10-01

Brief Summary

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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

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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.

Conditions

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Stroke

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Breathing Exercise

Group Type EXPERIMENTAL

Breathing Exercise

Intervention Type OTHER

Breathing exercise for stroke patients

Interventions

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Breathing Exercise

Breathing exercise for stroke patients

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ann Van de Winckel, PhD, MS, PT

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

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University of Minnesota

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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PMR-2017-25877

Identifier Type: -

Identifier Source: org_study_id

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