Stroke; ParalysisNCT05301946
Application of the ICF Core Set in Stroke Patients
An observational study of Stroke; Paralysis, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
Sixty patients with stroke were applied a-24-item ICF Core Set for Stroke, Standardized Mini-Mental State Examination(SMMSE), Stroke Impact Scale Version(SIS), Rivermead Mobility Index(RMI) and Home Safety Checklist(HSCL). Read more about this study
- Who is it for?
- Ages 25 to 80 years
- Conditions the study is for
- Stroke; Paralysis
- What is being tested?
- Outcome Measurements
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2019to 3 Feb 2022
- How long will I take part?
- 1 Day
- 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 25 to 80 years
- All sexes
- Adult, Older adult
Study population: 40 men, 20 women stroke patients who met the inclusion criteria. were included in the study.
Who may be able to join
- Being between the ages of 25-80,
- Having a single stroke,
- Not having any other condition affecting the evaluation such as aphasia, consciousness disorders, or other neurological diseases.
Who cannot join
- . Stroke patients who did not complete the evaluations.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Pamukkale University
Denizli, Kınıklı/Pamukkale, 20070
About this study
Official title: Application of the ICF Core Set for Cognitive Function, Quality of Life and Mobility in Stroke Patients
Sixty patients with stroke were applied a-24-item ICF Core Set for Stroke, Standardized Mini-Mental State Examination(SMMSE), Stroke Impact Scale Version(SIS), Rivermead Mobility Index(RMI) and Home Safety Checklist(HSCL). Spearman and Pearson correlation analysis was used to show the relation between the items of the scales and the ICF Core Set for Stroke items.
Read the detailed description
Fourty men and twenty women stroke patients were included in this study.The demographics and clinical information of the participants were recorded. A physiotherapist created an ICF Core Set for Stroke for the study. The ICF Core Set for Stroke was used to show the significant relationship with Standardized Mini-Mental State Examination, Stroke Impact Scale Version 3.0, and Rivermead Mobility Index. The duration of the assessment varied between 1 hour and 1.5 hours depending on the participant.
- Conditions
- Stroke; Paralysis
- Being tested
- Outcome Measurements
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Outcome MeasurementsOther
The 24-item ICF Core Set for Stroke, Standardized Mini-Mental State Examination, Stroke Impact Scale, Rivermead Mobility Index, and Home Safety Checklist were applied to the stroke patients. The assessment period took one hour.
| Study group | Role | What they receive |
|---|---|---|
| Stroke patients | The created-ICF Core Set for Stroke including activitiy, participation, and environmental factors was used show the meaningfulness of the clinical outcome measurements. The correlation of the created-ICF Core Set for Stroke's items and the outcome measurements were analyzed through Spearman or Pearson correlation analysis. Receives: Other: Outcome Measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standardized Mini-Mental State Examination
This scale was used to assess the cognitive status of stroke patients. The maximum score of SMMSE is 30 points.
Measured: One year
Stroke Impact Scale
This scale was used to assess the quality of life in stroke patients. Each domain is scored from 0 to 100.
Measured: One year
Rivermead Mobility Index
This scale was used to assess the mobility levels of stroke patients. The minimum and maximum scores are between 0-15.
Measured: One year
Home Safety Checklist
Ten items of this scale were used to assess the home safety status. The HSCL is scored between 0-65.
Measured: One year
A 24-item ICF Core Set for Stroke
The core set was created and consisted of 24 ICF items. Each category is scored between 0 - 4 and 8, or 9.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start1 Feb 2019
- Primary completion28 Dec 2021
- Study completion3 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Stroke; ParalysisStudies of the same condition, open and under way.
- More trials run by Pamukkale UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Güzin Kara, Pamukkale University
- Investigators
- Güzin Kara, Ph.D., Principal investigator, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05301946
- Sponsor's protocol ID
- 60116787-020/9175
- Status last verified
- Mar 2022
- First submitted
- 21 Mar 2022
- Last updated
- 8 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Tarvonen-Schroder S, Hurme S, Laimi K. The World Health Organization Disability Assessment Schedule (WHODAS 2.0) and the WHO Minimal Generic Set of Domains of Functioning and Health versus Conventional Instruments in subacute stroke. J Rehabil Med. 2019 Oct 4;51(9):675-682. doi: 10.2340/16501977-2583.
PubMed 31402390Sumathipala K, Radcliffe E, Sadler E, Wolfe CD, McKevitt C. Identifying the long-term needs of stroke survivors using the International Classification of Functioning, Disability and Health. Chronic Illn. 2012 Mar;8(1):31-44. doi: 10.1177/1742395311423848. Epub 2011 Oct 24.
PubMed 22025770Yarar F, Cavlak U, Basakci Calik B. Applying the International Classification of Functioning, Disability, and Health in children with low vision: differences between raters. Turk J Med Sci. 2016 Dec 20;46(6):1694-1699. doi: 10.3906/sag-1506-152.
PubMed 28081311
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of the ICF Core Set for Cognitive Function, Quality of Life and Mobility in Stroke Patients
- ClinicalTrials.gov ID
- NCT05301946
- Acronym / sponsor ID
- 60116787-020/9175
- Conditions
- Stroke; Paralysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 28 Dec 2021 (actual)
- Study completion
- 3 Feb 2022 (actual)
- First posted
- 31 Mar 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.
Sixty patients with stroke were applied a-24-item ICF Core Set for Stroke, Standardized Mini-Mental State Examination(SMMSE), Stroke Impact Scale Version(SIS), Rivermead Mobility Index(RMI) and Home Safety Checklist(HSCL). Spearman and Pearson correlation analysis was used to show the relation between the items of the scales and the ICF Core Set for Stroke items.
Detailed description
Fourty men and twenty women stroke patients were included in this study.The demographics and clinical information of the participants were recorded. A physiotherapist created an ICF Core Set for Stroke for the study. The ICF Core Set for Stroke was used to show the significant relationship with Standardized Mini-Mental State Examination, Stroke Impact Scale Version 3.0, and Rivermead Mobility Index. The duration of the assessment varied between 1 hour and 1.5 hours depending on the participant.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stroke patients | – | Other: Outcome MeasurementsThe created-ICF Core Set for Stroke including activitiy, participation, and environmental factors was used show the meaningfulness of the clinical outcome measurements. The correlation of the created-ICF Core Set for Stroke's items and the outcome measurements were analyzed through Spearman or Pearson correlation analysis. |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 40 men, 20 women stroke patients who met the inclusion criteria. were included in the study.
Key inclusion criteria (3 listed)
- Being between the ages of 25-80,
- Having a single stroke,
- Not having any other condition affecting the evaluation such as aphasia, consciousness disorders, or other neurological diseases.
Key exclusion criteria (1 listed)
- . Stroke patients who did not complete the evaluations.
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 |
|---|---|---|
| Outcome MeasurementsThe 24-item ICF Core Set for Stroke, Standardized Mini-Mental State Examination, Stroke Impact Scale, Rivermead Mobility Index, and Home Safety Checklist were applied to the stroke patients. The assessment period took one hour. | Other | Stroke patients |
Primary outcome
Standardized Mini-Mental State Examination
Time frame: One year
This scale was used to assess the cognitive status of stroke patients. The maximum score of SMMSE is 30 points.
Stroke Impact Scale
Time frame: One year
This scale was used to assess the quality of life in stroke patients. Each domain is scored from 0 to 100.
Rivermead Mobility Index
Time frame: One year
This scale was used to assess the mobility levels of stroke patients. The minimum and maximum scores are between 0-15.
Home Safety Checklist
Time frame: One year
Ten items of this scale were used to assess the home safety status. The HSCL is scored between 0-65.
A 24-item ICF Core Set for Stroke
Time frame: One year
The core set was created and consisted of 24 ICF items. Each category is scored between 0 - 4 and 8, or 9.
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 8 Apr 2022.
- Background: PubMed 31402390Tarvonen-Schroder S, Hurme S, Laimi K. The World Health Organization Disability Assessment Schedule (WHODAS 2.0) and the WHO Minimal Generic Set of Domains of Functioning and Health versus Conventional Instruments in subacute stroke. J Rehabil Med. 2019 Oct 4;51(9):675-682. doi: 10.2340/16501977-2583.
- Background: PubMed 22025770Sumathipala K, Radcliffe E, Sadler E, Wolfe CD, McKevitt C. Identifying the long-term needs of stroke survivors using the International Classification of Functioning, Disability and Health. Chronic Illn. 2012 Mar;8(1):31-44. doi: 10.1177/1742395311423848. Epub 2011 Oct 24.
- Background: PubMed 28081311Yarar F, Cavlak U, Basakci Calik B. Applying the International Classification of Functioning, Disability, and Health in children with low vision: differences between raters. Turk J Med Sci. 2016 Dec 20;46(6):1694-1699. doi: 10.3906/sag-1506-152.
- Individual participant dataSharing planned: Undecided
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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.
Güzin Kara, Ph.D. principal investigator
Pamukkale University
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; Paralysis, run by Pamukkale University at 1 site in Turkey (Türkiye).
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 3 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 8 Apr 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 Turkey (Türkiye). 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?
Standardized Mini-Mental State Examination (time frame: One year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05301946, which also lists 3 linked publications.
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 8 Apr 2022.