StrokeAFASNCT03328468
Development of Upper Limb Motor Scale to Measure Quality of Movement and Body Awareness in Stroke
A study testing Breathing Exercise in people with Stroke, run by University of Minnesota at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Stroke
- What is being tested?
- Breathing Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Dec 2017to 1 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Development of Upper Limb Motor Scale "Awareness of Functional Tasks With Arm and Hand in Stroke"
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Breathing Exercise
- Keywords
- Stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breathing ExerciseOther
Breathing exercise for stroke patients
| Study group | Role | What they receive |
|---|---|---|
| Breathing Exercise | Experimental | Not described Receives: Other: Breathing Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reliability of a new scale for stroke: Awareness of Functional Tasks with Arm and Hand in Stroke (AFAS scale)
AFAS contains 13 items
Measured: 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.
Measured: Baseline
Secondary outcomes (3)
Motor Evaluation Scale for Upper Extremity in Stroke Patients (MESUPES)
Scale using 0-58 for measurement, 0 being low and 58 being high. Assesses qualities of the arm and hand.
Measured: Baseline
Revised Body Awareness Rating Scale (REVBA)
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.
Measured: Baseline
Physical Body Experience Questionnaire (PBE)
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2017
- Study start30 Dec 2017
- Primary completion1 Oct 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ann Van de Winckel, PhD, MS, PT, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03328468
- Sponsor's protocol ID
- PMR-2017-25877
- Acronym
- AFAS
- Status last verified
- Nov 2024
- First submitted
- 19 Oct 2017
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Upper Limb Motor Scale "Awareness of Functional Tasks With Arm and Hand in Stroke"
- ClinicalTrials.gov ID
- NCT03328468
- Acronym / sponsor ID
- AFAS / PMR-2017-25877
- Conditions
- Stroke
- Keywords
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 30 Dec 2017 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 1 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breathing Exercise | Experimental | Other: Breathing Exercise |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breathing ExerciseBreathing exercise for stroke patients | Other | Breathing Exercise |
Primary outcome
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.
3 secondary outcomes
Motor Evaluation Scale for Upper Extremity in Stroke Patients (MESUPES)
Time frame: Baseline
Revised Body Awareness Rating Scale (REVBA)
Time frame: Baseline
Physical Body Experience Questionnaire (PBE)
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ann Van de Winckel, PhD, MS, PT principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breathing Exercise in people with Stroke, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reliability of a new scale for stroke: Awareness of Functional Tasks with Arm and Hand in Stroke (AFAS scale) (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2024.