DementiaNCT07139678
Safe Use of Mobility Aids Checklist (SUMAC) for 4-wheeled Walker Use in Turkish Geriatric Population
An observational study of Dementia, run by Ankara Yildirim Beyazıt University.
Trial summary
The goal of this observational study is to investigate the validity and reliability of the Safe Use of Mobility Aids Checklist (SUMAC) for 4-wheeled walker use in Turkish geriatric population. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- SUMAC
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 10 Sep 2025to 10 Jun 2026
- How long will I take part?
- 7 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: People who are 65 years or older with dementia will be included in the study. Participants will be selected from nursing homes.
Who may be able to join
- Having a diagnosed dementia
- Using 4-wheeled walker
- Being 65 years old or older
- Being able to understand and speak Turkish
- Having graduated from at least middle school
- Being able to follow the instructions and act accordingly
- Being able to walk without another person's help
- Having gotten 18-23 points from the The Mini Mental State Examination (MMSE)
Who cannot join
- Having mobility limitations due to musculoskeletal and neurological problems
- Having problems walking due to neurological diseases such as Parkinson, cerebrovascular diseases and so on
- Having balance problems due to vestibular conditions
- Having severe visual impairment and/or severe hearing loss
- Having unstable cardiovascular diseases
- Having malignancy and/or receiving treatment for malignancy
- Having had a surgery related to neurological and/or orthopedic problems in the past 6 months
- Not being willing to participate
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Turkish Reliability and Validity of the Safe Use of Mobility Aids Checklist (SUMAC) For 4-wheeled Walker Use
The goal of this observational study is to investigate the validity and reliability of the Safe Use of Mobility Aids Checklist (SUMAC) for 4-wheeled walker use in Turkish geriatric population. The main questions it aims to answer are:
Is SUMAC reliable for Turkish geriatric population? Is SUMAC valid for Turkish geriatric population?
Participants will fill out questionnaires and perform the tasks given in SUMAC.
Read the detailed description
Participants with dementia who are older than 65 years will be evaluated through some questionnaires such as Katz Index of Independence in Activities of Daily Living (ADL) and Mini-Mental State Examination. They will perform the Tinetti Test and their walking speed will also be measured. Participants will perform 9 tasks stated in SUMAC and will be recorded so that the investigators can score the tasks.
Tasks include: Transition of Sit to Stand, Gait with Pivot Turn To Approach Chair To Sit, Ambulation on a Level Surface, Walking While Performing Task of Horizontal Head Turns, Walking While Performing a Concurrent Cognitive Task, Walking While Negotiating Obstacles, Walking Through an Open Doorway, Open and Walk Through a Door that Opens Away From Person, Open and Walk Through Door that Opens Towards the Person.
This study contains 4 phases. Firstly, SUMAC will be translated to Turkish by two people whose native language is Turkish and who have full knowledge of the test terminology along with advanced knowledge of English. The Turkish version will be back translated to English by two native English speakers who are not connected to this study. The final translation will be determined by the committee which includes four translators and one Turkish philologist. In the second phase, participants will be filmed during their performances of the nine tasks in SUMAC. For recording, permission will be attained from participants and the people who are in charge of their care.
Recordings will be kept in a computer protected by a password, and will be deleted once the study is completed. For the third phase, a team of physiotherapists will complete the training for every taks in SUMAC in order to evaluate participants. In the fourth phase, SUMAC's reliability and validity for a Turkish geriatric population with dementia will be evaluated.
- Conditions
- Dementia
- Being tested
- SUMAC
- Keywords
- dependent ambulation, dementia
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SUMACOther
Participant will complete tasks given in SUMAC.
| Study group | Role | What they receive |
|---|---|---|
| Geriatric participants | Participants with dementia who are 65 years old or older Receives: Other: SUMAC |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Safe Use of Mobility Aids Checklist (SUMAC) for 4-wheeled walker
Participants will perform the tasks given in SUMAC. For reliability, they will perform the same tasks one week later.
Measured: 7 days
Secondary outcomes (1)
The Tinetti Test
The scores of the test will be used to determine the validity of Turkish SUMAC.
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2025
- Study start10 Sep 2025 (estimated)
- Primary completion10 Dec 2025 (estimated)
- Study completion10 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by Ankara Yildirim Beyazıt 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 crossover
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Betül Kaya, RA, Study director, Ankara Yildirim Beyazıt UniversityBahar Anaforoğlu, Prof., Principal investigator, Ankara Yildirim Beyazıt UniversityNezehat Ö Ünlüer, Assoc. Prof., Study director, Saglik Bilimleri UniversitesiYasemin Ateş Sarı, Dr., Study director, Ankara Yildirim Beyazıt UniversityBüşra Kalkan Balak, TA, Study director, Yüksek İhtisas UniversitySevilay S Baş, Dr., Study director, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07139678
- Sponsor's protocol ID
- 2022-1173
- Status last verified
- Aug 2025
- First submitted
- 18 Aug 2025
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ferrer A, Formiga F, Sanz H, de Vries OJ, Badia T, Pujol R; OCTABAIX Study Group. Multifactorial assessment and targeted intervention to reduce falls among the oldest-old: a randomized controlled trial. Clin Interv Aging. 2014 Feb 25;9:383-93. doi: 10.2147/CIA.S57580. eCollection 2014.
PubMed 24596458Shumway-Cook A, Ciol MA, Hoffman J, Dudgeon BJ, Yorkston K, Chan L. Falls in the Medicare population: incidence, associated factors, and impact on health care. Phys Ther. 2009 Apr;89(4):324-32. doi: 10.2522/ptj.20070107. Epub 2009 Feb 19.
PubMed 19228831Hartholt KA, van Beeck EF, Polinder S, van der Velde N, van Lieshout EM, Panneman MJ, van der Cammen TJ, Patka P. Societal consequences of falls in the older population: injuries, healthcare costs, and long-term reduced quality of life. J Trauma. 2011 Sep;71(3):748-53. doi: 10.1097/TA.0b013e3181f6f5e5.
PubMed 21045738Tan MP, Kamaruzzaman SB, Zakaria MI, Chin AV, Poi PJ. Ten-year mortality in older patients attending the emergency department after a fall. Geriatr Gerontol Int. 2016 Jan;16(1):111-7. doi: 10.1111/ggi.12446. Epub 2015 Jan 22.
PubMed 25613422Frith, K. H., Hunter, A. N., Coffey, S. S., & Khan, Z. (2019). A longitudinal fall prevention study for older adults. The journal for nurse practitioners, 15(4), 295-300.
Bateni H, Maki BE. Assistive devices for balance and mobility: benefits, demands, and adverse consequences. Arch Phys Med Rehabil. 2005 Jan;86(1):134-45. doi: 10.1016/j.apmr.2004.04.023.
PubMed 15641004Hartke RJ, Prohaska TR, Furner SE. Older adults and assistive devices: use, multiple-device use, and need. J Aging Health. 1998 Feb;10(1):99-116. doi: 10.1177/089826439801000106.
PubMed 10182420Hardi I, Bridenbaugh SA, Gschwind YJ, Kressig RW. The effect of three different types of walking aids on spatio-temporal gait parameters in community-dwelling older adults. Aging Clin Exp Res. 2014 Apr;26(2):221-8. doi: 10.1007/s40520-014-0204-4. Epub 2014 Mar 12.
PubMed 24619887Resnik L, Allen S, Isenstadt D, Wasserman M, Iezzoni L. Perspectives on use of mobility aids in a diverse population of seniors: implications for intervention. Disabil Health J. 2009 Apr;2(2):77-85. doi: 10.1016/j.dhjo.2008.12.002.
PubMed 20160951Tinetti ME, Speechley M, Ginter SF. Risk factors for falls among elderly persons living in the community. N Engl J Med. 1988 Dec 29;319(26):1701-7. doi: 10.1056/NEJM198812293192604.
PubMed 3205267Liu HH. Assessment of rolling walkers used by older adults in senior-living communities. Geriatr Gerontol Int. 2009 Jun;9(2):124-30. doi: 10.1111/j.1447-0594.2008.00497.x.
PubMed 19740354Liu HH, Eaves J, Wang W, Womack J, Bullock P. Assessment of canes used by older adults in senior living communities. Arch Gerontol Geriatr. 2011 May-Jun;52(3):299-303. doi: 10.1016/j.archger.2010.04.003. Epub 2010 Apr 22.
PubMed 20416960Hunter SW, Omana H, Madou E, Wittich W, Hill KD, Johnson AM, Divine A, Holmes JD. Effect of dual-tasking on walking and cognitive demands in adults with Alzheimer's dementia experienced in using a 4-wheeled walker. Gait Posture. 2020 Mar;77:164-170. doi: 10.1016/j.gaitpost.2020.01.024. Epub 2020 Feb 1.
PubMed 32044696Hunter SW, Divine A, Omana H, Wittich W, Hill KD, Johnson AM, Holmes JD. Effect of Learning to Use a Mobility Aid on Gait and Cognitive Demands in People with Mild to Moderate Alzheimer's Disease: Part II - 4-Wheeled Walker. J Alzheimers Dis. 2019;71(s1):S115-S124. doi: 10.3233/JAD-181170.
PubMed 31127767Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. doi: 10.1016/0021-9681(87)90171-8.
PubMed 3558716
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Turkish Reliability and Validity of the Safe Use of Mobility Aids Checklist (SUMAC) For 4-wheeled Walker Use
- ClinicalTrials.gov ID
- NCT07139678
- Acronym / sponsor ID
- 2022-1173
- Conditions
- Dementia
- Keywords
- dependent ambulation, dementia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 10 Sep 2025 (estimated)
- Primary completion
- 10 Dec 2025 (estimated)
- Study completion
- 10 Jun 2026 (estimated)
- First posted
- 24 Aug 2025 (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 goal of this observational study is to investigate the validity and reliability of the Safe Use of Mobility Aids Checklist (SUMAC) for 4-wheeled walker use in Turkish geriatric population. The main questions it aims to answer are:
Is SUMAC reliable for Turkish geriatric population? Is SUMAC valid for Turkish geriatric population?
Participants will fill out questionnaires and perform the tasks given in SUMAC.
Detailed description
Participants with dementia who are older than 65 years will be evaluated through some questionnaires such as Katz Index of Independence in Activities of Daily Living (ADL) and Mini-Mental State Examination. They will perform the Tinetti Test and their walking speed will also be measured. Participants will perform 9 tasks stated in SUMAC and will be recorded so that the investigators can score the tasks.
Tasks include: Transition of Sit to Stand, Gait with Pivot Turn To Approach Chair To Sit, Ambulation on a Level Surface, Walking While Performing Task of Horizontal Head Turns, Walking While Performing a Concurrent Cognitive Task, Walking While Negotiating Obstacles, Walking Through an Open Doorway, Open and Walk Through a Door that Opens Away From Person, Open and Walk Through Door that Opens Towards the Person.
This study contains 4 phases. Firstly, SUMAC will be translated to Turkish by two people whose native language is Turkish and who have full knowledge of the test terminology along with advanced knowledge of English. The Turkish version will be back translated to English by two native English speakers who are not connected to this study. The final translation will be determined by the committee which includes four translators and one Turkish philologist. In the second phase, participants will be filmed during their performances of the nine tasks in SUMAC. For recording, permission will be attained from participants and the people who are in charge of their care.
Recordings will be kept in a computer protected by a password, and will be deleted once the study is completed. For the third phase, a team of physiotherapists will complete the training for every taks in SUMAC in order to evaluate participants. In the fourth phase, SUMAC's reliability and validity for a Turkish geriatric population with dementia will be evaluated.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Target follow-up
- 7 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Geriatric participants | – | Other: SUMACParticipants with dementia who are 65 years old or older |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- People who are 65 years or older with dementia will be included in the study. Participants will be selected from nursing homes.
Key inclusion criteria (8 listed)
- Having a diagnosed dementia
- Using 4-wheeled walker
- Being 65 years old or older
- Being able to understand and speak Turkish
- Having graduated from at least middle school
Key exclusion criteria (8 listed)
- Having mobility limitations due to musculoskeletal and neurological problems
- Having problems walking due to neurological diseases such as Parkinson, cerebrovascular diseases and so on
- Having balance problems due to vestibular conditions
- Having severe visual impairment and/or severe hearing loss
- Having unstable cardiovascular diseases
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 |
|---|---|---|
| SUMACParticipant will complete tasks given in SUMAC. | Other | Geriatric participants |
Primary outcome
The Safe Use of Mobility Aids Checklist (SUMAC) for 4-wheeled walker
Time frame: 7 days
Participants will perform the tasks given in SUMAC. For reliability, they will perform the same tasks one week later.
1 secondary outcome
The Tinetti Test
Time frame: 15 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
- Background: PubMed 24596458Ferrer A, Formiga F, Sanz H, de Vries OJ, Badia T, Pujol R; OCTABAIX Study Group. Multifactorial assessment and targeted intervention to reduce falls among the oldest-old: a randomized controlled trial. Clin Interv Aging. 2014 Feb 25;9:383-93. doi: 10.2147/CIA.S57580. eCollection 2014.
- Background: PubMed 19228831Shumway-Cook A, Ciol MA, Hoffman J, Dudgeon BJ, Yorkston K, Chan L. Falls in the Medicare population: incidence, associated factors, and impact on health care. Phys Ther. 2009 Apr;89(4):324-32. doi: 10.2522/ptj.20070107. Epub 2009 Feb 19.
- Background: PubMed 21045738Hartholt KA, van Beeck EF, Polinder S, van der Velde N, van Lieshout EM, Panneman MJ, van der Cammen TJ, Patka P. Societal consequences of falls in the older population: injuries, healthcare costs, and long-term reduced quality of life. J Trauma. 2011 Sep;71(3):748-53. doi: 10.1097/TA.0b013e3181f6f5e5.
- Background: PubMed 25613422Tan MP, Kamaruzzaman SB, Zakaria MI, Chin AV, Poi PJ. Ten-year mortality in older patients attending the emergency department after a fall. Geriatr Gerontol Int. 2016 Jan;16(1):111-7. doi: 10.1111/ggi.12446. Epub 2015 Jan 22.
- BackgroundFrith, K. H., Hunter, A. N., Coffey, S. S., & Khan, Z. (2019). A longitudinal fall prevention study for older adults. The journal for nurse practitioners, 15(4), 295-300.
- Background: PubMed 15641004Bateni H, Maki BE. Assistive devices for balance and mobility: benefits, demands, and adverse consequences. Arch Phys Med Rehabil. 2005 Jan;86(1):134-45. doi: 10.1016/j.apmr.2004.04.023.
- Background: PubMed 10182420Hartke RJ, Prohaska TR, Furner SE. Older adults and assistive devices: use, multiple-device use, and need. J Aging Health. 1998 Feb;10(1):99-116. doi: 10.1177/089826439801000106.
- Background: PubMed 24619887Hardi I, Bridenbaugh SA, Gschwind YJ, Kressig RW. The effect of three different types of walking aids on spatio-temporal gait parameters in community-dwelling older adults. Aging Clin Exp Res. 2014 Apr;26(2):221-8. doi: 10.1007/s40520-014-0204-4. Epub 2014 Mar 12.
- Background: PubMed 20160951Resnik L, Allen S, Isenstadt D, Wasserman M, Iezzoni L. Perspectives on use of mobility aids in a diverse population of seniors: implications for intervention. Disabil Health J. 2009 Apr;2(2):77-85. doi: 10.1016/j.dhjo.2008.12.002.
- Background: PubMed 3205267Tinetti ME, Speechley M, Ginter SF. Risk factors for falls among elderly persons living in the community. N Engl J Med. 1988 Dec 29;319(26):1701-7. doi: 10.1056/NEJM198812293192604.
- Background: PubMed 19740354Liu HH. Assessment of rolling walkers used by older adults in senior-living communities. Geriatr Gerontol Int. 2009 Jun;9(2):124-30. doi: 10.1111/j.1447-0594.2008.00497.x.
- Background: PubMed 20416960Liu HH, Eaves J, Wang W, Womack J, Bullock P. Assessment of canes used by older adults in senior living communities. Arch Gerontol Geriatr. 2011 May-Jun;52(3):299-303. doi: 10.1016/j.archger.2010.04.003. Epub 2010 Apr 22.
- 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.
Betül Kaya, RA study director
Ankara Yildirim Beyazıt University
Bahar Anaforoğlu, Prof. principal investigator
Ankara Yildirim Beyazıt University
Nezehat Ö Ünlüer, Assoc. Prof. study director
Saglik Bilimleri Universitesi
Questions about this trial
What is this clinical trial studying?
An observational study of Dementia, run by Ankara Yildirim Beyazıt University.
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 8 inclusion and 8 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: opening soon, as of the sponsor's last update on 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sevilay S Baş, Dr. (+905332056064, ssbas@aybu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Safe Use of Mobility Aids Checklist (SUMAC) for 4-wheeled walker (time frame: 7 days). 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 NCT07139678, which also lists 26 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 24 Aug 2025.