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

June 11, 2026 updated by: Mehmet Kaan ALTUNOK, Selcuk University

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.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey (Türkiye)
    • Selcuklu
      • Konya, Selcuklu, Turkey (Türkiye), 42130
        • Recruiting
        • Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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,
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Individuals with Type 2 Diabetes Mellitus
Adults 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.
Other: Mixed Reality-Based Functional Performance Assessment
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
6-Minute Walk Test - Mixed Reality (6MW-MR)
Time Frame: Baseline and 1-week follow-up
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.
Baseline and 1-week follow-up
Timed Up and Go Test - Mixed Reality (TUG-MR)
Time Frame: Baseline and 1-week follow-up
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.
Baseline and 1-week follow-up
Five-Repetition Sit-to-Stand Test - Mixed Reality (5xSTS-MR)
Time Frame: Baseline and 1-week follow-up
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.
Baseline and 1-week follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Participant Satisfaction
Time Frame: Baseline
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.
Baseline
6-Minute Walk Test - Conventional
Time Frame: Baseline
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.
Baseline
Timed Up and Go Test - Conventional
Time Frame: Baseline
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.
Baseline
Five-Repetition Sit-to-Stand Test - Conventional
Time Frame: Baseline
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.
Baseline
Knee Extensor Muscle Strength
Time Frame: Baseline
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.
Baseline
Handgrip Strength
Time Frame: Baseline
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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Selcuk University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Gülşah ÖZSOY, Assist. Prof. Dr., Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Konya, Türkiye
  • Study Chair: Zehra KORKUT, Assist. Prof. Dr., Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Konya, Türkiye
  • Study Chair: İsmail ÖZSOY, Assoc. Prof. Dr., Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Konya, Türkiye
  • Study Chair: Mehmet A GÜLER, PhD, Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Konya, Türkiye
  • Study Chair: İhsan KODAK, Assist. Prof. Dr., Kırşehir Ahi Evran University, School of Physical Therapy and Rehabilitation, Kırşehir, Türkiye
  • Study Chair: Yasemin GEDİKLİ ERTÜRK, PhD (c) in PT, Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Konya, Türkiye
  • Study Chair: Selma Ö ÇELİKDELEN, Assist. Prof. Dr., Konya City Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 10, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 10, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 11, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 11, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 16, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SelcukU_PT_DM_MR_ADAPTATİON_1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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