Spinal Cord InjuriesNCT04234269
Physical Activity Scale in Individuals With Spinal Cord Injury
An observational study of Spinal Cord Injuries, run by Istinye University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to improve the cultural adaptation and Turkish version of the The Physical Activity Scale for Individuals With Physical Disabilities (PASIPD) and to investigate the validity and reliability of the Turkish version of PASIPD in individuals with spinal cord injury. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Assessment
- How many people
- 47 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2019to 1 Nov 2019
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Our study will be made on Turkey Spinal Cord Injury Association in ages ranging from ages 18-75 enrolled 47 volunteers.
Who may be able to join
- Classified as group A, B, C or D according to American Spinal Injury Association (diagnosed with spinal cord injury),
- Fully or partially wheelchair dependent
- Over 18 years old
- Willing to research,
- Can read and write and read and write in Turkish
- Patients without cognitive impairment.
- Having the upper extremity muscle strength required for wheelchair use
Who cannot join
- Reluctant and unwilling to research,
- Having any progressive discomfort
- Bed dependent,
- Patients with severe cognitive impairment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cultural Adaptation and Turkish Version of Physical Activity Scale for Individuals With Physical Disabilities in Individuals With Spinal Cord Injury: a Reliability and Validity Study
The aim of this study was to improve the cultural adaptation and Turkish version of the The Physical Activity Scale for Individuals With Physical Disabilities (PASIPD) and to investigate the validity and reliability of the Turkish version of PASIPD in individuals with spinal cord injury. PASIPD, which consists of 13 questions, will be adapted to Turkish by translation and back translation method. The study included 47 wheelchair-dependent patients over the age of 18 who were able to read and write Turkish (26 females, 21 males). In order to determine the reliability and internal consistency of PASIPD, item-total correlation, if item deleted cronbach alpha coefficient and cronbach alpha coefficient of the whole scale will be calculated. Test-retest method will be used for the stability of the scale. In the test-retest method, the scale will be re-applied to the same people with 7-day intervals. Pearson correlation analysis will be performed between the first test and the second test total and sub-parameters after 1 week. Test-retest reliability will be determined using the intraclass correlation coefficient (ICC). In the validity test of PASIPD; construct validity and criterion validity will be used. Test of construct validity; factor analysis and convergent and discriminant validity methods. The Barthel Index of Activities of Daily Living and Functional Independence Measure (FIM); World Health Organization Quality of Life Scale Abbreviated Version (WHOQOL-BREF), Nottingham Health Profile (NHP) and Craig Handicap Assessment and Reporting Technique (CHART-SF) will be used to convergent and discriminant validity. Manual Wheelchair Propulsion Tests will be used to demonstrate criterion validity.
- Conditions
- Spinal Cord Injuries
- Being tested
- Assessment
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AssessmentOther
Evaluation forms will be applied to the patients who meet the inclusion criteria by face to face interview method.The sociodemographic information of the patients and the time taken to answer the questions in the questionnaires will vary according to each patient, but will take approximately 45 minutes. The second interview will be conducted with the patients for test-retest application at 1 week intervals.
| Study group | Role | What they receive |
|---|---|---|
| Assessment Group | Individuals with spinal cord injury. There is one group. Receives: Other: Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Independence Measure
Functional Independence Measure evaluates the daily living activities. It comprises 18 items; 13 motor items (self-care and locomotion) and five cognitive items (communication and cognition), each of which is scored on a seven-point scale. The motor and cognitive scores have been separated, and each score now has a range of 0-100. The total score ranges from 13 to 126. A lower score indicates a worse functional level.
Measured: 12 weeks
The Barthel Index of Activities of Daily Living
The Barthel Index evaluates the activities of daily living. The total Barthel Index score ranges from 0-100. 0 represents full dependency, 100 represents full independence. A score above 60 indicates independence in daily living activities.
Measured: 12 weeks
20 meters push test
It is the one of the Manual Wheelchair Propulsion Tests. Manual Wheelchair Propulsion Tests to evaluate participants' ability to use manual wheelchairs. Patients ride their wheelchairs as fast as they can on a 20-meter course. At this time, the evaluator records how many seconds the 20-meter course is completed.
Measured: 12 weeks
slalom test
It is the one of the Manual Wheelchair Propulsion Tests. Manual Wheelchair Propulsion Tests to evaluate participants' ability to use manual wheelchairs. An 18-meter course; 3 cones at 3 meter intervals, 2 cones at 2 meter intervals, 2 cones at 1 meter intervals. Patients progress by making slalom between cones and come back by making slalom from the last cone. At this time, an evaluator records the number of seconds the track has been completed.
Measured: 12 weeks
6 Minute Push Test
It is the one of the Manual Wheelchair Propulsion Tests. Manual Wheelchair Propulsion Tests to evaluate participants' ability to use manual wheelchairs. An eight-course track of 25 meters in length; in the middle and on both sides of the cones. Patients start in the middle of the course. It then moves quickly to the cone on the right or left edge and returns to the center of the track. At the next stage, it moves to the cone on the other side of the course and proceeds for 6 minutes. At this time, an evaluator will record the number of meters traveled in 6 minutes.
Measured: 12 weeks
Nottingham Health Profile
It measures the quality of life. The questionnaire consists of 38 items and evaluates six dimensions related to health status. Questions are answered as yes or no. Each section is scored between 0-100. 0 indicates the best health status, 100 indicates the worst health status.
Measured: 12 weeks
World Health Organization Quality of Life Scale Abbreviated Version
World Health Organization Quality of Life Scale Abbreviated Version evaluates the quality of life. It consists of 4 sections: physical health (seven items), psychological health (six items), social relations (three items), environment (eight items), and two additional items that score the perception of health and quality of life.The minimum score is 0 and the maximum score is 100. Higher score shows better result.
Measured: 12 weeks
Craig Handicap Assessment and Reporting Technique.
Craig Handicap Assessment and Reporting Technique evaluates the quality of life. The scale consists of 5 parts: physical independence, mobility, roles and activities, social integration, economic self-sufficiency. Each parameter is scored between 0-100. The higher the participation, the higher the score, the lower the disability. The maximum score of 100 represents the level of participation of the non-disabled person.
Measured: 12 weeks
Physical Activity Scale for Individuals with Physical Disabilities
The Physical Activity Scale for Individuals with Physical Disabilities evaluates the physical activity level. It is a 13-item personal report form for the purpose of classifying daily living activities (items 1-6), domestic activities (items 7-12) and professional tasks (items 13) in the last seven days.The minimum score is 0 MET hr/d and the maximum score is 199.5 MET hr/d. Higher score shows better result.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2020
- Study start1 Jun 2019
- Primary completion30 Oct 2019
- Study completion1 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by Istinye 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasemin Çırak, Istinye University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04234269
- Sponsor's protocol ID
- 006
- Status last verified
- Jul 2020
- First submitted
- 2 Jan 2020
- Last updated
- 30 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Koce K, Atici E, Buran Cirak Y, Durustkan Elbasi N, Tutuneken YE. Cultural adaptation and Turkish version of Physical Activity Scale for Individuals with Physical Disabilities in individuals with spinal cord injury: a reliability and validity study. Disabil Rehabil. 2022 Oct;44(21):6414-6423. doi: 10.1080/09638288.2021.1964624. Epub 2021 Aug 20.
PubMed 34415222
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cultural Adaptation and Turkish Version of Physical Activity Scale for Individuals With Physical Disabilities in Individuals With Spinal Cord Injury: a Reliability and Validity Study
- ClinicalTrials.gov ID
- NCT04234269
- Acronym / sponsor ID
- 006
- Conditions
- Spinal Cord Injuries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 30 Oct 2019 (actual)
- Study completion
- 1 Nov 2019 (actual)
- First posted
- 21 Jan 2020 (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.
The aim of this study was to improve the cultural adaptation and Turkish version of the The Physical Activity Scale for Individuals With Physical Disabilities (PASIPD) and to investigate the validity and reliability of the Turkish version of PASIPD in individuals with spinal cord injury. PASIPD, which consists of 13 questions, will be adapted to Turkish by translation and back translation method. The study included 47 wheelchair-dependent patients over the age of 18 who were able to read and write Turkish (26 females, 21 males). In order to determine the reliability and internal consistency of PASIPD, item-total correlation, if item deleted cronbach alpha coefficient and cronbach alpha coefficient of the whole scale will be calculated. Test-retest method will be used for the stability of the scale. In the test-retest method, the scale will be re-applied to the same people with 7-day intervals. Pearson correlation analysis will be performed between the first test and the second test total and sub-parameters after 1 week. Test-retest reliability will be determined using the intraclass correlation coefficient (ICC). In the validity test of PASIPD; construct validity and criterion validity will be used. Test of construct validity; factor analysis and convergent and discriminant validity methods. The Barthel Index of Activities of Daily Living and Functional Independence Measure (FIM); World Health Organization Quality of Life Scale Abbreviated Version (WHOQOL-BREF), Nottingham Health Profile (NHP) and Craig Handicap Assessment and Reporting Technique (CHART-SF) will be used to convergent and discriminant validity. Manual Wheelchair Propulsion Tests will be used to demonstrate criterion validity.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Assessment Group | – | Other: AssessmentIndividuals with spinal cord injury. There is one group. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Our study will be made on Turkey Spinal Cord Injury Association in ages ranging from ages 18-75 enrolled 47 volunteers.
Key inclusion criteria (7 listed)
- Classified as group A, B, C or D according to American Spinal Injury Association (diagnosed with spinal cord injury),
- Fully or partially wheelchair dependent
- Over 18 years old
- Willing to research,
- Can read and write and read and write in Turkish
Key exclusion criteria (4 listed)
- Reluctant and unwilling to research,
- Having any progressive discomfort
- Bed dependent,
- Patients with severe cognitive impairment.
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 |
|---|---|---|
| AssessmentEvaluation forms will be applied to the patients who meet the inclusion criteria by face to face interview method.The sociodemographic information of the patients and the time taken to answer the questions in the questionnaires will vary according to each patient, but will take approximately 45 minutes. The second interview will be conducted with the patients for test-retest application at 1 week intervals. | Other | Assessment Group |
Primary outcome
Functional Independence Measure
Time frame: 12 weeks
Functional Independence Measure evaluates the daily living activities. It comprises 18 items; 13 motor items (self-care and locomotion) and five cognitive items (communication and cognition), each of which is scored on a seven-point scale. The motor and cognitive scores have been separated, and each score now has a range of 0-100. The total score ranges from 13 to 126. A lower score indicates a worse functional level.
The Barthel Index of Activities of Daily Living
Time frame: 12 weeks
The Barthel Index evaluates the activities of daily living. The total Barthel Index score ranges from 0-100. 0 represents full dependency, 100 represents full independence. A score above 60 indicates independence in daily living activities.
20 meters push test
Time frame: 12 weeks
It is the one of the Manual Wheelchair Propulsion Tests. Manual Wheelchair Propulsion Tests to evaluate participants' ability to use manual wheelchairs. Patients ride their wheelchairs as fast as they can on a 20-meter course. At this time, the evaluator records how many seconds the 20-meter course is completed.
slalom test
Time frame: 12 weeks
It is the one of the Manual Wheelchair Propulsion Tests. Manual Wheelchair Propulsion Tests to evaluate participants' ability to use manual wheelchairs. An 18-meter course; 3 cones at 3 meter intervals, 2 cones at 2 meter intervals, 2 cones at 1 meter intervals. Patients progress by making slalom between cones and come back by making slalom from the last cone. At this time, an evaluator records the number of seconds the track has been completed.
6 Minute Push Test
Time frame: 12 weeks
It is the one of the Manual Wheelchair Propulsion Tests. Manual Wheelchair Propulsion Tests to evaluate participants' ability to use manual wheelchairs. An eight-course track of 25 meters in length; in the middle and on both sides of the cones. Patients start in the middle of the course. It then moves quickly to the cone on the right or left edge and returns to the center of the track. At the next stage, it moves to the cone on the other side of the course and proceeds for 6 minutes. At this time, an evaluator will record the number of meters traveled in 6 minutes.
Nottingham Health Profile
Time frame: 12 weeks
It measures the quality of life. The questionnaire consists of 38 items and evaluates six dimensions related to health status. Questions are answered as yes or no. Each section is scored between 0-100. 0 indicates the best health status, 100 indicates the worst health status.
World Health Organization Quality of Life Scale Abbreviated Version
Time frame: 12 weeks
World Health Organization Quality of Life Scale Abbreviated Version evaluates the quality of life. It consists of 4 sections: physical health (seven items), psychological health (six items), social relations (three items), environment (eight items), and two additional items that score the perception of health and quality of life.The minimum score is 0 and the maximum score is 100. Higher score shows better result.
Craig Handicap Assessment and Reporting Technique.
Time frame: 12 weeks
Craig Handicap Assessment and Reporting Technique evaluates the quality of life. The scale consists of 5 parts: physical independence, mobility, roles and activities, social integration, economic self-sufficiency. Each parameter is scored between 0-100. The higher the participation, the higher the score, the lower the disability. The maximum score of 100 represents the level of participation of the non-disabled person.
Physical Activity Scale for Individuals with Physical Disabilities
Time frame: 12 weeks
The Physical Activity Scale for Individuals with Physical Disabilities evaluates the physical activity level. It is a 13-item personal report form for the purpose of classifying daily living activities (items 1-6), domestic activities (items 7-12) and professional tasks (items 13) in the last seven days.The minimum score is 0 MET hr/d and the maximum score is 199.5 MET hr/d. Higher score shows better result.
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 30 Jul 2020.
- Derived from this study: PubMed 34415222Koce K, Atici E, Buran Cirak Y, Durustkan Elbasi N, Tutuneken YE. Cultural adaptation and Turkish version of Physical Activity Scale for Individuals with Physical Disabilities in individuals with spinal cord injury: a reliability and validity study. Disabil Rehabil. 2022 Oct;44(21):6414-6423. doi: 10.1080/09638288.2021.1964624. Epub 2021 Aug 20.
- 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.
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 Spinal Cord Injuries, run by Istinye 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 7 inclusion and 4 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 30 Jul 2020. 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?
Functional Independence Measure (time frame: 12 weeks). The study lists 9 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 NCT04234269, which also lists 1 linked publication.
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 30 Jul 2020.