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Type 2 Diabetes Mellitus (T2DM)NCT07649967

Validity and Reliability of Mixed Reality-Based Functional Mobility Tests in Type 2 Diabetes

An observational study of Type 2 Diabetes Mellitus (T2DM), run by Selcuk University at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Type 2 Diabetes Mellitus (T2DM) is a multifaceted metabolic disease associated not only with impaired glycemic control but also with reductions in muscle strength, balance, functional mobility, and walking performance. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Type 2 Diabetes Mellitus (T2DM)
What is being tested?
Mixed Reality-Based Functional Performance Assessment
How many people
75 participants
Where
1 siteTurkey (Türkiye)
Study dates
10 Jun 2026to 10 May 2027
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 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adults aged 18-65 years diagnosed with Type 2 Diabetes Mellitus who are able to ambulate independently, are clinically stable, and are eligible to participate in conventional and mixed reality-based functional performance assessments.

Who may be able to join

  • Diagnosed with Type 2 Diabetes Mellitus by a physician,
  • Aged between 18 and 65 years,
  • Ability to ambulate independently without the use of an assistive device,
  • No participation in a structured exercise program within the previous 6 months,
  • Cognitive ability sufficient to understand and follow test instructions,
  • Visual, auditory, and vestibular functions sufficient to tolerate mixed reality applications,
  • Ability to read, understand, and follow instructions in Turkish,
  • Willingness to participate voluntarily in the study and provision of written informed consent.

Who cannot join

  • Presence of proliferative diabetic retinopathy or severe non-proliferative diabetic retinopathy,
  • Advanced peripheral neuropathy, active foot ulcer, Charcot foot, or significant sensory loss that may compromise safe test performance,
  • Presence of peripheral arterial disease,
  • Advanced renal failure, requirement for dialysis, or nephropathy that may compromise exercise safety,
  • Myocardial infarction within the previous 6 months,
  • Unstable ischemic heart disease or uncontrolled angina,
Show all 10Show fewer
  • Resting blood pressure greater than 160/100 mmHg,
  • Presence of severe musculoskeletal, neurological, or vestibular disorders that may interfere with safe test performance,
  • High risk of balance loss or spatial disorientation in the mixed reality environment due to visual, auditory, or balance impairments,
  • Cognitive, behavioral, or compliance-related problems that may prevent completion of the study procedures.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Mehmet K ALTUNOK, PHD(c) in PT contact

5558175133 ext. +90

mehmetkaan.altunok@selcuk.edu.tr

Turkey (Türkiye)1 site, 1 recruiting
  • Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation

    Konya, Selcuklu, 42130

    Mehmet K ALTUNOK, PHD(c) in PT, 5558175133 ext. +90, mehmetkaan.altunok@selcuk.edu.tr

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: Validity and Reliability of the Mixed Reality Adaptation of the 6-Minute Walk, Timed Up and Go, and Five-Repetition Sit-to-Stand Tests in Individuals With Type 2 Diabetes Mellitus

Type 2 Diabetes Mellitus (T2DM) is a multifaceted metabolic disease associated not only with impaired glycemic control but also with reductions in muscle strength, balance, functional mobility, and walking performance. Individuals with T2DM may experience impairments in lower extremity function, postural control, and overall functional performance, which can negatively affect activities of daily living and quality of life. Therefore, the assessment of functional performance using reliable and valid methods is important for clinical monitoring and rehabilitation planning.

The 6-Minute Walk Test (6MWT), Timed Up and Go Test (TUG), and Five-Repetition Sit-to-Stand Test (5xSTS) are widely used clinical assessments for evaluating walking capacity, functional mobility, lower extremity function, and physical performance in individuals with T2DM. Previous studies have demonstrated that these tests provide reliable and clinically meaningful measurements in this population.

Read more

In recent years, virtual and mixed reality technologies have provided opportunities to conduct assessments in a more objective, standardized, and user-friendly manner. These technologies also offer important advantages, including real-time data collection, enhanced user interaction, and potential integration into future remote assessment applications. However, evidence regarding the measurement properties of mixed reality-based adaptations of commonly used functional performance tests in individuals with T2DM remains limited.

The aim of this study is to evaluate the validity and reliability of mixed reality-based adaptations of the 6-Minute Walk Test, Timed Up and Go Test, and Five-Repetition Sit-to-Stand Test developed using the Meta Quest 3 platform. In addition, convergent validity will be examined by investigating the relationships between outcomes obtained from the mixed reality-based assessments and measures of knee extensor muscle strength and handgrip strength.

The findings of this study are expected to contribute to the development of innovative, safe, standardized, and digital approaches for assessing functional performance in individuals with Type 2 Diabetes Mellitus. Furthermore, the results may provide a scientific foundation for future digital health applications and remote assessment strategies.

Being tested
Mixed Reality-Based Functional Performance Assessment
Keywords
Type 2 Diabetes Mellitus, Mixed Reality, Functional Mobility, 6-Minute Walk Test, Timed Up and Go Test, Five-Repetition Sit-to-Stand Test, Validity, Reliability
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mixed Reality-Based Functional Performance AssessmentOther

    Participants will perform mixed reality-based adaptations of the 6-Minute Walk Test (6MW-MR), Timed Up and Go Test (TUG-MR), and Five-Repetition Sit-to-Stand Test (5xSTS-MR) developed for the Meta Quest 3 platform. The mixed reality environment digitally replicates the conventional test setups and provides standardized visual guidance while allowing participants to interact safely with the real environment. Test outcomes will be automatically recorded by the system and compared with conventional clinical assessments to evaluate validity. The mixed reality-based tests will be repeated one week later to assess test-retest reliability.

Study groups in NCT07649967
Study groupRoleWhat they receive
Individuals with Type 2 Diabetes MellitusAdults aged 18-65 years diagnosed with Type 2 Diabetes Mellitus who will undergo conventional and mixed reality-based assessments of functional performance, including the 6-Minute Walk Test, Timed Up and Go Test, and Five-Repetition Sit-to-Stand Test. Additional assessments of knee extensor muscle strength and handgrip strength will be performed to evaluate convergent validity.
Receives: Other: Mixed Reality-Based Functional Performance Assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 6-Minute Walk Test - Mixed Reality (6MW-MR)

    Functional exercise capacity and walking endurance will be assessed using a mixed reality-based adaptation of the 6-Minute Walk Test. Walking distance will be recorded in meters, with greater distances indicating better performance. Validity will be evaluated by comparison with the conventional 6-Minute Walk Test, and reliability will be assessed using repeated measurements performed one week apart.

    Measured: Baseline and 1-week follow-up

  2. Timed Up and Go Test - Mixed Reality (TUG-MR)

    Functional mobility will be assessed using a mixed reality-based adaptation of the Timed Up and Go Test. Test completion time will be recorded in seconds, with shorter times indicating better functional mobility. Validity and reliability will be evaluated through comparison with the conventional Timed Up and Go Test and repeated measurements.

    Measured: Baseline and 1-week follow-up

  3. Five-Repetition Sit-to-Stand Test - Mixed Reality (5xSTS-MR)

    Lower extremity functional performance will be assessed using a mixed reality-based adaptation of the Five-Repetition Sit-to-Stand Test. Test duration will be recorded in seconds, with shorter times indicating better performance. Validity and reliability will be evaluated through comparison with the conventional Five-Repetition Sit-to-Stand Test and repeated measurements.

    Measured: Baseline and 1-week follow-up

Secondary outcomes (6)
  1. 6-Minute Walk Test - Conventional

    Walking distance measured during the conventional 6-Minute Walk Test will be used as a reference measure for concurrent validity analyses. Greater distances indicate better functional exercise capacity.

    Measured: Baseline

  2. Timed Up and Go Test - Conventional

    The conventional Timed Up and Go Test will be administered to assess functional mobility and will serve as a reference measure for validity analyses. Test completion time will be recorded in seconds, with shorter times indicating better functional mobility.

    Measured: Baseline

  3. Five-Repetition Sit-to-Stand Test - Conventional

    The conventional Five-Repetition Sit-to-Stand Test will be used as a reference measure for validity analyses. Test completion time will be recorded in seconds, with shorter times indicating better lower extremity functional performance.

    Measured: Baseline

  4. Knee Extensor Muscle Strength

    Knee extensor muscle strength will be measured using a handheld digital dynamometer. Maximum voluntary contraction values will be recorded, with higher values indicating greater muscle strength. Outcomes will be analyzed for convergent validity with mixed reality-based test results.

    Measured: Baseline

  5. Handgrip Strength

    Handgrip strength will be assessed using a hand dynamometer. The highest value obtained from repeated trials will be recorded, with higher values indicating greater muscle strength. Outcomes will be analyzed for convergent validity with mixed reality-based test results.

    Measured: Baseline

  6. Participant Satisfaction

    Participant satisfaction with conventional and mixed reality-based assessments will be evaluated using a 10-point visual analog scale ranging from 1 to 10, with higher scores indicating greater satisfaction.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jun 2026
  2. Study start10 Jun 2026
  3. Primary completion30 Dec 2026 (estimated)
  4. Study completion10 May 2027 (estimated)

Resources

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
Other
Time perspective
Cross-sectional
Enrolment
75 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07649967
Sponsor's protocol ID
SelcukU_PT_DM_MR_ADAPTATİON_1
Status last verified
Jun 2026
First submitted
11 Jun 2026
Last updated
16 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Vaz MM, Costa GC, Reis JG, Junior WM, Albuquerque de Paula FJ, Abreu DC. Postural control and functional strength in patients with type 2 diabetes mellitus with and without peripheral neuropathy. Arch Phys Med Rehabil. 2013 Dec;94(12):2465-2470. doi: 10.1016/j.apmr.2013.06.007. Epub 2013 Jun 24.

    PubMed 23806609
  • Sousa-Santos AR, Amaral TF. Differences in handgrip strength protocols to identify sarcopenia and frailty - a systematic review. BMC Geriatr. 2017 Oct 16;17(1):238. doi: 10.1186/s12877-017-0625-y.

    PubMed 29037155
  • Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991 Feb;39(2):142-8. doi: 10.1111/j.1532-5415.1991.tb01616.x.

    PubMed 1991946
  • Munoz-Bermejo L, Adsuar JC, Mendoza-Munoz M, Barrios-Fernandez S, Garcia-Gordillo MA, Perez-Gomez J, Carlos-Vivas J. Test-Retest Reliability of Five Times Sit to Stand Test (FTSST) in Adults: A Systematic Review and Meta-Analysis. Biology (Basel). 2021 Jun 9;10(6):510. doi: 10.3390/biology10060510.

    PubMed 34207604
  • Maden C, Gozacan Karabulut D, Bagci B. Validity and reliability of an immersive virtual reality adaptation of the 6-minute pegboard and ring test. Hand Surg Rehabil. 2025 Feb;44(1):101981. doi: 10.1016/j.hansur.2024.101981. Epub 2024 Oct 30.

    PubMed 39486588
  • Lee MC. Validity of the 6-minute walk test and step test for evaluation of cardio respiratory fitness in patients with type 2 diabetes mellitus. J Exerc Nutrition Biochem. 2018 Mar 30;22(1):49-55. doi: 10.20463/jenb.2018.0008.

    PubMed 29673246
  • Kowall B. Lower body muscle strength, dynapenic obesity and risk of type 2 diabetes -longitudinal results on the chair-stand test from the Survey of Health, Ageing and Retirement in Europe (SHARE). BMC Geriatr. 2022 Dec 1;22(1):924. doi: 10.1186/s12877-022-03647-7.

    PubMed 36456934
  • Greco F, Tarsitano MG, Cosco LF, Quinzi F, Folino K, Spadafora M, Afzal M, Segura-Garcia C, Maurotti S, Pujia R, Pujia A, Buono P, Emerenziani GP. The Effects of Online Home-Based Pilates Combined with Diet on Body Composition in Women Affected by Obesity: A Preliminary Study. Nutrients. 2024 Mar 21;16(6):902. doi: 10.3390/nu16060902.

    PubMed 38542813
  • Goldberg A, Chavis M, Watkins J, Wilson T. The five-times-sit-to-stand test: validity, reliability and detectable change in older females. Aging Clin Exp Res. 2012 Aug;24(4):339-44. doi: 10.1007/BF03325265.

    PubMed 23238309
  • Dominguez-Munoz FJ, Adsuar JC, Villafaina S, Garcia-Gordillo MA, Hernandez-Mocholi MA, Collado-Mateo D, Gusi N. Test-Retest Reliability of Vibration Perception Threshold Test in People with Type 2 Diabetes Mellitus. Int J Environ Res Public Health. 2020 Mar 9;17(5):1773. doi: 10.3390/ijerph17051773.

    PubMed 32182888
  • ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available.

    PubMed 12091180
  • Cesari M, Kritchevsky SB, Newman AB, Simonsick EM, Harris TB, Penninx BW, Brach JS, Tylavsky FA, Satterfield S, Bauer DC, Rubin SM, Visser M, Pahor M; Health, Aging and Body Composition Study. Added value of physical performance measures in predicting adverse health-related events: results from the Health, Aging And Body Composition Study. J Am Geriatr Soc. 2009 Feb;57(2):251-9. doi: 10.1111/j.1532-5415.2008.02126.x.

    PubMed 19207142
  • Bayram GA, Sahin GE, Yilmaz G, Tayboga UI, Celik AG, Yildirim Y, Saribas PK, Tarakci D. Integration of the wingate anaerobic test into a virtual reality- based evaluation system. BMC Sports Sci Med Rehabil. 2025 Jul 2;17(1):163. doi: 10.1186/s13102-025-01220-4.

    PubMed 40605090
  • Alfonso-Rosa RM, Del Pozo-Cruz B, Del Pozo-Cruz J, Sanudo B, Rogers ME. Test-retest reliability and minimal detectable change scores for fitness assessment in older adults with type 2 diabetes. Rehabil Nurs. 2014 Sep-Oct;39(5):260-8. doi: 10.1002/rnj.111. Epub 2013 Jun 18.

    PubMed 23780835

Questions about this trial

What is this clinical trial studying?

An observational study of Type 2 Diabetes Mellitus (T2DM), run by Selcuk 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 8 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 16 Jun 2026. 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?

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 Mehmet K ALTUNOK, PHD(c) in PT (5558175133 ext. +90, mehmetkaan.altunok@selcuk.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

6-Minute Walk Test - Mixed Reality (6MW-MR) (time frame: Baseline and 1-week follow-up). The study lists 3 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 NCT07649967, which also lists 14 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 16 Jun 2026.

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