StrokeNCT05259215
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 study of Stroke, run by Ukrainian Association of Physical Therapy at 1 site in Ukraine.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- physiotherapy
- How many people
- 29 participants
- Where
- 1 siteUkraine
- Study dates
- 1 Jan 2020to 31 Dec 2020
- Phase
- Observational
- 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 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with stroke
Who may be able to join
- Male or female patients with stroke after the age of 17 confirmed stroke by neuroimaging, understanding instructions, time after stroke up to 1 year.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Ukraine1 site
communal non-commercial enterprise "Kyiv Regional Clinical Hospital", Department of Rehabilitation of Patients with Consequences of Diseases and Injuries of the Nervous System
Kyiv, 04106
About this study
Official title: 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.
- Conditions
- Stroke
- Being tested
- physiotherapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physiotherapyOther
Standard usual care physiotherapy after stroke
| Study group | Role | What they receive |
|---|---|---|
| non-walking group | Not described Receives: Other: physiotherapy | |
| independently walking group | Not described Receives: Other: physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Ambulation Category
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.
Measured: 1-5 minutes
Secondary outcomes (3)
Simplified Stroke Rehabilitation Assessment of Movement (S-STREAM)
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.
Measured: 15-20 minutes
Berg Balance Scale (BBS)
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.
Measured: 15-20 minutes
Barthel Index for Activities of Daily Living (BI)
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.
Measured: 15-20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2022
- Study start1 Jan 2020
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ukrainian Association of Physical Therapy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mykola Romanyshyn, Ukrainian Association of Physical Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05259215
- Sponsor's protocol ID
- UAPT 0001
- Status last verified
- Feb 2022
- First submitted
- 17 Feb 2022
- Last updated
- 28 Feb 2022
- Results posted
- No
- 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 28 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05259215
- Acronym / sponsor ID
- UAPT 0001
- Conditions
- Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Ukrainian Association of Physical TherapyUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 28 Feb 2022 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| non-walking group | – | Other: physiotherapy |
| independently walking group | – | Other: physiotherapy |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with stroke
Key inclusion criteria (1 listed)
- Male or female patients with stroke after the age of 17 confirmed stroke by neuroimaging, understanding instructions, time after stroke up to 1 year.
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| physiotherapyStandard usual care physiotherapy after stroke | Other | independently walking group, non-walking group |
Primary outcome
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.
3 secondary outcomes
Simplified Stroke Rehabilitation Assessment of Movement (S-STREAM)
Time frame: 15-20 minutes
Berg Balance Scale (BBS)
Time frame: 15-20 minutes
Barthel Index for Activities of Daily Living (BI)
Time frame: 15-20 minutes
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 28 Feb 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Ukrainian Association of Physical Therapy at 1 site in Ukraine.
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 1 inclusion and 1 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 28 Feb 2022. 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 Ukraine. 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?
Functional Ambulation Category (time frame: 1-5 minutes). 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 28 Feb 2022.