StrokeNCT06011174
Validity and Reliability of the Turkish Version of the Post-Stroke Physical Activity Barriers Scale in Patients with Stroke
An observational study of Stroke and Physical Inactivity, run by Kırıkkale University at 1 site in Turkey (Türkiye).
Trial summary
Stroke is one of the leading causes that negatively affects quality of life. The benefits of regular physical activity are well recognized. Physical activity after stroke may prevent disability and recurrence of stroke. Physical impairments seen after stroke may prevent exercise and limit subsequent recovery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke, Physical Inactivity
- What is being tested?
- survey application
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2023to 5 Feb 2024
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A standard probability in their use of validity and reliability is unlikely. Generally, it states that at least 3 or 5-10 people should be recruited for each lime substance in lime studies (1,2). For this reason, since the Turkish version of the Post-Stroke Physical Activity Barriers Scale, which consists of 14 items, contains the validity and reliability, it is planned to enroll 70 people with stroke, whose item approach is 5 times higher. Patients coming to Kırıkkale University Faculty of Medicine Physical Therapy and Rehabilitation Hospital will be included in the study.
Who may be able to join
- 1. Being 18 years of age or older, 2. being diagnosed with hemorrhagic or ischemic stroke, 3. No cooperation and communication problems 4. Being able to walk independently
Who cannot join
- 1. Having another neurological or orthopedic problem other than stroke that may affect functionality, ambulation and balance 2. Individuals with advanced cardiovascular disease that may prevent physical activity and contraindications for mobilization will not be included in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kırıkkale University
Kirikkale, Kırıkkale, 71450
About this study
Stroke is one of the leading causes that negatively affects quality of life. The benefits of regular physical activity are well recognized. Physical activity after stroke may prevent disability and recurrence of stroke. Physical impairments seen after stroke may prevent exercise and limit subsequent recovery. According to a 2016 systematic review updated and published in the Cochrane Library, physical activity programs have positive effects on disability, physical abilities, quality of life, mood and cardiovascular. However, these effects tend to diminish unless the individual's physical activity level is maintained. Therefore, individuals who have had a stroke should be encouraged to exercise. However, it has been reported that most of the patients do not participate in exercise programs as recommended after stroke and there is a decrease in physical activity level. Previous studies have reported that approximately 77% of patients with stroke are sedentary or have low levels of physical activity and also reduced frequency of physical activity. This may be a consequence of the reduced movement speed seen due to severe motor impairments. Interestingly, even those with mild motor impairments, i.e. those walking at speeds above 0.8 m/s and able to participate in community-based exercises, were found to have low levels of physical activity. Therefore, environmental and personal factors can also be barriers to exercise.
Research supports the use of the theoretical model of behavior change developed by Prochaska et al. in physical activity promotion. Individuals are thought to progress through the stages of change at different rates. The concepts of self-efficacy and decision balance (perceived benefits and barriers) are particularly salient for individuals in the pre-thinking and thinking stages. Therefore, identifying and understanding perceived barriers to engaging in physical activity is an important step in creating change in physical activity behaviors. The International Classification of Functioning, Disability and Health defines functioning and disability as multidimensional concepts in which activity, especially physical activity, is influenced by organic and contextual factors. These dimensions often change after stroke and create multiple barriers that may prevent the patient from returning to a physically active lifestyle. Previous studies on barriers to physical activity in stroke survivors have used open-ended questionnaires. When we look at the scales examining exercise and physical activity barriers in the literature, it is seen that they were developed to measure physical activity barriers in the general population and in individuals with chronic conditions. Therefore, the Barriers to Physical Activity After Stroke (BAPAS) scale was developed by Drigny et al. in 2019 to help physicians and therapists identify potential targets for future interventions and optimize clinical follow-up in stroke patients and to assess barriers to physical activity after stroke. The original scale is in French and there is also an English version. Since the scale was recently developed, there is no Turkish version and no version in other languages.
- Conditions
- Stroke, Physical Inactivity
- Being tested
- survey application
- Medical subject headings
- Stroke, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
survey applicationOther
Participants will only be asked to fill out the questionnaires.
| Study group | Role | What they receive |
|---|---|---|
| post-stroke patient | 1. Being 18 years of age or older,
2. being diagnosed with hemorrhagic or ischemic stroke,
3. No cooperation and communication problems
4. Being able to walk independently Receives: Other: survey application |
What is being measured
The primary outcome is the main question the study is designed to answer.
the Barriers to Physical Activity After Stroke (BAPAS) SCALE
The necessary permissions were obtained from the authors of the BAPAS, whose validity and reliability features were to be tested, and the questionnaire was finalized by completing the translation process into Turkish. What is essential in the use of special tools such as scales is to prove the usability of the tool in the sample group to which it will be applied. The first step for this is the translation from the original language to the other language. At this stage, it is ideal to have a good knowledge of the structure of the target language and the original language.
is to have competent and experienced people do the translation
Measured: 10 minute
Secondary outcomes (2)
The Barthel Activities of Daily Living Index (BADLI)
SURVEY
Measured: 5 minute
The Rivermead motor assessment (RMA)
SURVEY
Measured: 2 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study start1 Jun 2023
- Primary completion15 Dec 2023
- Study completion5 Feb 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.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kırıkkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alper Kemal Gürbüz, Kırıkkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06011174
- Sponsor's protocol ID
- Gurbuz03
- Status last verified
- Aug 2023
- First submitted
- 21 Aug 2023
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability of the Turkish Version of the Post-Stroke Physical Activity Barriers Scale in Patients with Stroke
- ClinicalTrials.gov ID
- NCT06011174
- Acronym / sponsor ID
- Gurbuz03
- Conditions
- Stroke, Physical Inactivity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Kırıkkale UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 5 Feb 2024 (actual)
- First posted
- 25 Aug 2023 (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.
Stroke is one of the leading causes that negatively affects quality of life. The benefits of regular physical activity are well recognized. Physical activity after stroke may prevent disability and recurrence of stroke. Physical impairments seen after stroke may prevent exercise and limit subsequent recovery. According to a 2016 systematic review updated and published in the Cochrane Library, physical activity programs have positive effects on disability, physical abilities, quality of life, mood and cardiovascular. However, these effects tend to diminish unless the individual's physical activity level is maintained. Therefore, individuals who have had a stroke should be encouraged to exercise. However, it has been reported that most of the patients do not participate in exercise programs as recommended after stroke and there is a decrease in physical activity level. Previous studies have reported that approximately 77% of patients with stroke are sedentary or have low levels of physical activity and also reduced frequency of physical activity. This may be a consequence of the reduced movement speed seen due to severe motor impairments. Interestingly, even those with mild motor impairments, i.e. those walking at speeds above 0.8 m/s and able to participate in community-based exercises, were found to have low levels of physical activity. Therefore, environmental and personal factors can also be barriers to exercise.
Research supports the use of the theoretical model of behavior change developed by Prochaska et al. in physical activity promotion. Individuals are thought to progress through the stages of change at different rates. The concepts of self-efficacy and decision balance (perceived benefits and barriers) are particularly salient for individuals in the pre-thinking and thinking stages. Therefore, identifying and understanding perceived barriers to engaging in physical activity is an important step in creating change in physical activity behaviors. The International Classification of Functioning, Disability and Health defines functioning and disability as multidimensional concepts in which activity, especially physical activity, is influenced by organic and contextual factors. These dimensions often change after stroke and create multiple barriers that may prevent the patient from returning to a physically active lifestyle. Previous studies on barriers to physical activity in stroke survivors have used open-ended questionnaires. When we look at the scales examining exercise and physical activity barriers in the literature, it is seen that they were developed to measure physical activity barriers in the general population and in individuals with chronic conditions. Therefore, the Barriers to Physical Activity After Stroke (BAPAS) scale was developed by Drigny et al. in 2019 to help physicians and therapists identify potential targets for future interventions and optimize clinical follow-up in stroke patients and to assess barriers to physical activity after stroke. The original scale is in French and there is also an English version. Since the scale was recently developed, there is no Turkish version and no version in other languages.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| post-stroke patient | – | Other: survey application1. Being 18 years of age or older, 2. being diagnosed with hemorrhagic or ischemic stroke, 3. No cooperation and communication problems 4. Being able to walk independently |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A standard probability in their use of validity and reliability is unlikely. Generally, it states that at least 3 or 5-10 people should be recruited for each lime substance in lime studies (1,2). For this reason, since the Turkish version of the Post-Stroke Physical Activity Barriers Scale, which consists of 14 items, contains the validity and reliability, it is planned to enroll 70 people with stroke, whose item approach is 5 times higher. Patients coming to Kırıkkale University Faculty of Medicine Physical Therapy and Rehabilitation Hospital will be included in the study.
Key inclusion criteria (1 listed)
- 1. Being 18 years of age or older, 2. being diagnosed with hemorrhagic or ischemic stroke, 3. No cooperation and communication problems 4. Being able to walk independently
Key exclusion criteria (1 listed)
- 1. Having another neurological or orthopedic problem other than stroke that may affect functionality, ambulation and balance 2. Individuals with advanced cardiovascular disease that may prevent physical activity and contraindications for mobilization will not be included in the study.
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 |
|---|---|---|
| survey applicationParticipants will only be asked to fill out the questionnaires. | Other | post-stroke patient |
Primary outcome
the Barriers to Physical Activity After Stroke (BAPAS) SCALE
Time frame: 10 minute
The necessary permissions were obtained from the authors of the BAPAS, whose validity and reliability features were to be tested, and the questionnaire was finalized by completing the translation process into Turkish. What is essential in the use of special tools such as scales is to prove the usability of the tool in the sample group to which it will be applied. The first step for this is the translation from the original language to the other language. At this stage, it is ideal to have a good knowledge of the structure of the target language and the original language. is to have competent and experienced people do the translation
2 secondary outcomes
The Barthel Activities of Daily Living Index (BADLI)
Time frame: 5 minute
The Rivermead motor assessment (RMA)
Time frame: 2 minute
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 14 Mar 2025.
- Individual participant dataSharing planned: Yes
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.
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 and Physical Inactivity, run by Kırıkkale 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 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 14 Mar 2025. 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?
the Barriers to Physical Activity After Stroke (BAPAS) SCALE (time frame: 10 minute). 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 14 Mar 2025.