NCT07139678

Brief 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. 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
1mo left

Started Sep 2025

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress88%
Sep 2025Jun 2026

First Submitted

Initial submission to the registry

August 18, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 24, 2025

Completed
17 days until next milestone

Study Start

First participant enrolled

September 10, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2026

Expected
Last Updated

August 24, 2025

Status Verified

August 1, 2025

Enrollment Period

3 months

First QC Date

August 18, 2025

Last Update Submit

August 18, 2025

Conditions

Keywords

dependent ambulationdementia

Outcome Measures

Primary Outcomes (1)

  • 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.

    7 days

Secondary Outcomes (1)

  • The Tinetti Test

    15 days

Study Arms (1)

Geriatric participants

Participants with dementia who are 65 years old or older

Other: SUMAC

Interventions

SUMACOTHER

Participant will complete tasks given in SUMAC.

Geriatric participants

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

People who are 65 years or older with dementia will be included in the study. Participants will be selected from nursing homes.

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (26)

  • 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.

    PMID: 24596458BACKGROUND
  • Shumway-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.

    PMID: 19228831BACKGROUND
  • Hartholt 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.

    PMID: 21045738BACKGROUND
  • Tan 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.

    PMID: 25613422BACKGROUND
  • Frith, 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
  • 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.

    PMID: 15641004BACKGROUND
  • Hartke 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.

    PMID: 10182420BACKGROUND
  • Hardi 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.

    PMID: 24619887BACKGROUND
  • Resnik 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.

    PMID: 20160951BACKGROUND
  • Tinetti 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.

    PMID: 3205267BACKGROUND
  • Liu 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.

    PMID: 19740354BACKGROUND
  • Liu 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.

    PMID: 20416960BACKGROUND
  • Hunter 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.

    PMID: 32044696BACKGROUND
  • Hunter 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.

    PMID: 31127767BACKGROUND
  • Charlson 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.

    PMID: 3558716BACKGROUND
  • KATZ S, FORD AB, MOSKOWITZ RW, JACKSON BA, JAFFE MW. STUDIES OF ILLNESS IN THE AGED. THE INDEX OF ADL: A STANDARDIZED MEASURE OF BIOLOGICAL AND PSYCHOSOCIAL FUNCTION. JAMA. 1963 Sep 21;185:914-9. doi: 10.1001/jama.1963.03060120024016. No abstract available.

    PMID: 14044222BACKGROUND
  • Katz S, Downs TD, Cash HR, Grotz RC. Progress in development of the index of ADL. Gerontologist. 1970 Spring;10(1):20-30. doi: 10.1093/geront/10.1_part_1.20. No abstract available.

    PMID: 5420677BACKGROUND
  • Arik G, Varan HD, Yavuz BB, Karabulut E, Kara O, Kilic MK, Kizilarslanoglu MC, Sumer F, Kuyumcu ME, Yesil Y, Halil M, Cankurtaran M. Validation of Katz index of independence in activities of daily living in Turkish older adults. Arch Gerontol Geriatr. 2015 Nov-Dec;61(3):344-50. doi: 10.1016/j.archger.2015.08.019. Epub 2015 Aug 28.

    PMID: 26328478BACKGROUND
  • Shubert TE, Schrodt LA, Mercer VS, Busby-Whitehead J, Giuliani CA. Are scores on balance screening tests associated with mobility in older adults? J Geriatr Phys Ther. 2006;29(1):35-9.

    PMID: 16630375BACKGROUND
  • Folstein MF, Robins LN, Helzer JE. The Mini-Mental State Examination. Arch Gen Psychiatry. 1983 Jul;40(7):812. doi: 10.1001/archpsyc.1983.01790060110016. No abstract available.

    PMID: 6860082BACKGROUND
  • Molloy DW, Standish TI. A guide to the standardized Mini-Mental State Examination. Int Psychogeriatr. 1997;9 Suppl 1:87-94; discussion 143-50. doi: 10.1017/s1041610297004754.

    PMID: 9447431BACKGROUND
  • Gungen C, Ertan T, Eker E, Yasar R, Engin F. [Reliability and validity of the standardized Mini Mental State Examination in the diagnosis of mild dementia in Turkish population]. Turk Psikiyatri Derg. 2002 Winter;13(4):273-81. Turkish.

    PMID: 12794644BACKGROUND
  • Hunter SW, Divine A, Omana H, Madou E, Holmes J. Development, reliability and validity of the Safe Use of Mobility Aids Checklist (SUMAC) for 4-wheeled walker use in people living with dementia. BMC Geriatr. 2020 Nov 11;20(1):468. doi: 10.1186/s12877-020-01865-5.

    PMID: 33176695BACKGROUND
  • Yücel, S. D., Şahin, F., Doğu, B., Şahin, T., Kuran, B., & Gürsakal, S. (2012). Reliability and validity of the Turkish version of the Performance-Oriented Mobility Assessment I. European Review of Aging and Physical Activity, 9(2), 149-159.

    BACKGROUND
  • Beaton DE, Bombardier C, Guillemin F, Ferraz MB. Guidelines for the process of cross-cultural adaptation of self-report measures. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3186-91. doi: 10.1097/00007632-200012150-00014. No abstract available.

    PMID: 11124735BACKGROUND
  • Safe Use of Mobility Aids Checklist (SUMAC) documents (2022, October 25), retrieved from: http://www.mobility-in-aging-lab.ca/#publications

    BACKGROUND

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Betül Kaya, RA

    Ankara Yildirim Beyazıt University

    STUDY DIRECTOR
  • Bahar Anaforoğlu, Prof.

    Ankara Yildirim Beyazıt University

    PRINCIPAL INVESTIGATOR
  • Nezehat Ö Ünlüer, Assoc. Prof.

    Saglik Bilimleri Universitesi

    STUDY DIRECTOR
  • Yasemin Ateş Sarı, Dr.

    Ankara Yildirim Beyazıt University

    STUDY DIRECTOR
  • Büşra Kalkan Balak, TA

    Yüksek İhtisas University

    STUDY DIRECTOR
  • Sevilay S Baş, Dr.

    Ankara Yildirim Beyazıt University

    STUDY DIRECTOR

Central Study Contacts

Sevilay S Baş, Dr.

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Target Duration
7 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2025

First Posted

August 24, 2025

Study Start

September 10, 2025

Primary Completion

December 10, 2025

Study Completion (Estimated)

June 10, 2026

Last Updated

August 24, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share