- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05259215
Predicting Independent Walking Ability Using the Simplified Stroke Rehabilitation Assessment of Movement, Berg Balance Scale, Barthel Index for Activities of Daily Living in Individuals Post Stroke
February 17, 2022 updated by: Mykola Romanyshyn, Ukrainian Association of Physical Therapy
Predicting Independent Walking Ability Using the Simplified Stroke Rehabilitation Assessment of Movement, Berg Balance Scale, Barthel Index for Activities of Daily Living in Individuals Post Stroke: an Observational Pilot Study
Cohort observational retrospective pilot study by design.
The purpose of this study was to determine a cut scores to predict independent ambulation for the Simplified Stroke Rehabilitation Assessment of Movement, Berg Balance Scale, Barthel Index for Activities of Daily Living.
Study Overview
Study Type
Observational
Enrollment (Actual)
29
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Kyiv, Ukraine, 04106
- communal non-commercial enterprise "Kyiv Regional Clinical Hospital", Department of Rehabilitation of Patients with Consequences of Diseases and Injuries of the Nervous System
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
17 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
patients with stroke
Description
Inclusion Criteria:
- Male or female patients with stroke after the age of 17 confirmed stroke by neuroimaging, understanding instructions, time after stroke up to 1 year.
Exclusion Criteria:
- Subjects were excluded if they have: the presence of aphasia that would have interfered with the participant's ability to understand and comply with study procedures or complete stroke assessments, dementia, ataxia, localization of stroke in the cerebellum or vertebrobasilar insufficiency, orthopedic problems that affected the ability to walk before the stroke and time after stroke more than 1 year.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
non-walking group
|
Standard usual care physiotherapy after stroke
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independently walking group
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Standard usual care physiotherapy after stroke
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Functional Ambulation Category
Time Frame: 1-5 minutes
|
The Functional Ambulation Categories (FAC) is a 6-point functional walking test that evaluates ambulation ability, determining how much human support the patient requires when walking, regardless of whether or not they use a personal assistive device.
|
1-5 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Simplified Stroke Rehabilitation Assessment of Movement (S-STREAM)
Time Frame: 15-20 minutes
|
The Stroke Rehabilitation Assessment of Movement (STREAM) instrument was designed to provide a comprehensive and quantitative evaluation of voluntary movements (ie, an impairment measurement) and basic mobility (ie, a disability measurement) in patients with stroke.
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15-20 minutes
|
Berg Balance Scale (BBS)
Time Frame: 15-20 minutes
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The Berg Balance Scale (BBS) is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks.
|
15-20 minutes
|
Barthel Index for Activities of Daily Living (BI)
Time Frame: 15-20 minutes
|
The Barthel Index (BI) measures the extent to which somebody can function independently and has mobility in their activities of daily living (ADL) i.e. feeding, bathing, grooming, dressing, bowel control, bladder control, toileting, chair transfer, ambulation and stair climbing.
|
15-20 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2020
Primary Completion (Actual)
December 31, 2020
Study Completion (Actual)
December 31, 2020
Study Registration Dates
First Submitted
February 17, 2022
First Submitted That Met QC Criteria
February 17, 2022
First Posted (Actual)
February 28, 2022
Study Record Updates
Last Update Posted (Actual)
February 28, 2022
Last Update Submitted That Met QC Criteria
February 17, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UAPT 0001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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