ClinicalTrials.gg
RecruitingNCT07357662EXG-FOOTUpdated Aug 11, 2026

Effects of Rehabilitative Exergame Training on Foot Muscle Activity, Balance, and Mobility in Older Adults

An interventional study of Exergame-based Balance and Foot Muscle Training and Conventional Functional Balance Training in Aging, Foot Muscle Dysfunction and Sarcopenia, sponsored by Tarsus University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 65 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-11.

Sponsored by Tarsus University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jun 2026; still recruiting 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
65 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 130 studies in Sarcopenia with a site in Turkey — 36 open to participants now, 43 under way, none of them phase 3. Sarcopenia · Turkey.

Planned enrollment
14th of 33
40 · median 40
Started
2026
with 26 others
No phase
31 of 130
6 open now
Primary completion
2026-12
later than 27 of 42 live
Registered
93rd of 130
by date

Among the 130 studies in Sarcopenia with a site in Turkey, this one is the 14th largest by planned enrollment of the 33 interventional ones, is one of 27 that started in 2026, is one of 31 with no phase, reaches primary completion later than 27 of the 42 other live ones, and was the 93rd registered.

By phase

130 studies; the count open now beside each. This study's row is marked.

Observational97 · 30 open
No phasethis study31 · 6 open
Phase 21 · 0 open
Phase 41 · 0 open

By the year they started

First in 2016; this study’s year is marked. 27 started in 2026.

Size and results

Median enrollment 40 across the 33 interventional studies, 100 across the 97 observational. Of the 75 that completed or were terminated, 0 (0%) have results posted.

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02

Study summary

This study is designed as a randomized controlled trial. A total of 40 healthy older adults residing in private and public nursing homes and rehabilitation centers in Mersin will be enrolled. Participants will be randomly assigned to either the intervention group (Group 1) or the control group (Group 2).

The intervention group will receive rehabilitative interactive game-based exercise training, while the control group will receive functional balance exercise training. Both groups will participate in exercise sessions three times per week, with each session lasting 40 minutes, over a period of 8 weeks.

Participants will undergo pre- and post-intervention assessments, including:

i) clinical tests and measurements for cognitive, functional, and balance evaluation; ii) surface electromyography (sEMG) measurements recorded during the Functional Reach Test (FRT); and iii) biomechanical measurements obtained via integrated inertial measurement unit (IMU) sensors (accelerometer and gyroscope) and the Becure game board.

Electrophysiological and biomechanical data will be analyzed using statistical comparisons, correlation analyses, and regression models. Variables derived from time, frequency, and time-frequency domain analyses will be examined to identify potential sEMG and biomechanical biomarkers.

Read the detailed description

The increasing prevalence of sedentary lifestyles among older adults represents a major public health concern, as it accelerates age-related declines in physical mobility, muscle strength, postural control, and balance. These declines contribute to an increased risk of falls, highlighting the need for effective and innovative intervention strategies.

Rehabilitative interactive games (exergames) have emerged as a promising intervention by combining motor learning components, such as balance and functional mobility, with cognitive engagement. However, the effects of exergames on lower extremity functionality, balance performance, and their association with neuromuscular activity remain insufficiently understood.

This study adopts an innovative approach by employing surface electromyography (sEMG) to investigate electromyography-force relationships in trunk, leg, and foot muscles-an area that has received limited attention in the existing literature. While prior research has predominantly focused on traditional clinical assessments such as the Functional Reach Test (FRT) or ankle joint biomechanics, this study emphasizes the functional contribution of muscles involved in foot arch stabilization and toe control. This perspective aims to provide additional insight into the coordinated roles of foot, leg, and trunk musculature in balance and mobility.

The study will be conducted as a randomized controlled trial including 40 healthy older adults residing in nursing homes and rehabilitation centers in Mersin. Participants will be randomly allocated to either an intervention group receiving exergame-based exercise training or a control group receiving functional balance exercises. Both groups will complete 40-minute exercise sessions three times per week for a duration of eight weeks.

Pre- and post-intervention assessments will include:

i) clinical tests and measurements evaluating cognitive, functional, and balance performance; ii) surface EMG recordings obtained during the Functional Reach Test to assess muscle activity of the trunk, thigh, leg, and foot; and iii) biomechanical data collected using force plates and integrated IMU sensors (accelerometers and gyroscopes) synchronized with the surface EMG system.

Collected data will be analyzed across time, frequency, and time-frequency domains to examine relationships between electrophysiological and biomechanical variables. Statistical analyses will include comparative analyses, correlation analyses, and regression models to identify potential electrophysiological and biomechanical biomarkers associated with balance performance and exercise-related outcomes.

03

Conditions studied

  • Aging
  • Foot Muscle Dysfunction
  • Sarcopenia
  • Age-Related Muscle Weakness

Keywords

  • older adults, physical activity, interactive computer games, biomarkers, electrophysiology, biomedical signal processing
  • Older adults
  • Biomedical signal processing
  • Physical activity
04

Who can participate

Ages eligible
65 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Aged 65 to 80 years
  • Having a minimum of 5 years of formal education
  • Ability to walk independently for at least 10 meters, with or without a walking aid if necessary
  • Having sufficient cognitive function for communication and participation, defined as a (MMSE) score ≥26

Exclusion criteria

Exclusion Criteria:

  • (BMI ≥30 kg/m²)
  • Presence of central or peripheral nervous system disorders or use of medications that may affect balance
  • History of vestibular pathology
  • Lower extremity amputation, prior lower extremity surgery, or affecting the lower extremities
  • Presence of moderate to severe congenital heart disease, coronary artery disease, or cerebrovascular disease
  • Presence of visual, psychiatric, or cognitive impairments that could interfere with study participation or assessment procedures
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Exergame-based Balance and Foot Muscle Training

    Participants in the intervention group will undergo an 8-week supervised exercise program, consisting of 40-minute sessions performed two times per week. Each session will include a 5-minute warm-up, followed by the main exergame-based balance and foot muscle training, and a 5-minute cool-down period. The exercises will focus on improving postural control, foot muscle activation, balance, and mobility using rehabilitative exergame applications.

    Other: Exergame-based Balance and Foot Muscle Training

  • Active comparator
    Functional balance training

    Participants in the control group will receive an 8-week supervised functional balance training program, consisting of 40-minute sessions performed two times per week. Each session will include a 5-minute warm-up, followed by 30 minutes of conventional functional balance exercises (such as static and dynamic standing balance, weight shifting, step training, and postural stabilization tasks), and a 5-minute cool-down period.

    Other: Conventional Functional Balance Training

Interventions

  • OtherExergame-based Balance and Foot Muscle Training

    The interventions will carried out two days a week and 40 minutes, for eight weeks.

  • OtherConventional Functional Balance Training

    he interventions will carried out two days a week and 40 minutes, for eight weeks.

06

What researchers measure

Primary outcomes

  1. Standardized Mini-Mental State Examination (SMMSE).

    The Standardized Mini-Mental State Examination (SMMSE) is a widely used, brief cognitive screening tool adapted from the original Mini-Mental State Examination. It evaluates global cognitive function across several domains, including orientation, attention, immediate and delayed memory, language, and visuospatial abilities. The total score ranges from 0 to 30, with lower scores indicating greater cognitive impairment. The SMMSE is administered face-to-face and typically requires 5-10 minutes to complete. In this study, the SMMSE is used to screen cognitive eligibility and ensure participants have sufficient cognitive capacity to follow instructions and provide informed consent.

    Time frame: Baseline (Pre-intervention assessment, Week 0)

  2. Surface EMG Frequency-Domain Parameters During Functional Reach Test

    Surface EMG Frequency-Domain Parameters During Functional Reach Test Description: Frequency-domain characteristics of the surface EMG signal will be analyzed during the Functional Reach Test to evaluate neuromuscular activation patterns. Parameters such as median frequency and mean frequency will be extracted to assess muscle activation characteristics. Unit of Measure: Hertz (Hz) Time Frame: Baseline (Week 0) and Post-intervention (Week 8)

    Time frame: baseline and 8 weeks later

  3. Timed Up and Go Test (TUG)

    The Timed Up and Go (TUG) test is one of the most commonly used clinical tools for the assessment of balance and gait and is recommended by clinical practice guidelines for evaluating fall risk (Bohannon, 2006). This relatively simple assessment measures the time required for an individual to stand up from a chair, walk 3 meters, turn, return to the chair, and sit down, with the total duration recorded in seconds. A cut-off value of 14 seconds has been suggested to indicate increased fall risk. In the Cognitive Timed Up and Go test (TUG-cognitive), participants are additionally instructed to count backward by threes as quickly and safely as possible, starting from a randomly selected number between 20 and 100, while performing the motor task. A cognitive task duration of ≥15 seconds has been reported to predict backward falls with an accuracy of 87%.

    Time frame: Baseline (Week 0) and Post-intervention (8 Week )

  4. Electrophysiological Measurements Using Surface EMG

    Surface EMG Muscle Activation During Functional Reach Test Description: Surface electromyography (sEMG) will be used to assess neuromuscular activation of trunk and lower extremity muscles during the Functional Reach Test. Muscle activation will be quantified using amplitude-based parameters derived from the sEMG signal, including root mean square (RMS) values. Unit of Measure: Microvolts (µV), RMS Time Frame: Baseline (Week 0) and Post-intervention (Week 8)

    Time frame: Baseline (Week 0) and Post-intervention (Week 8)

  5. Center of Pressure (CoP) Displacement

    Center of pressure displacement will be measured using the Sensormedica platform to assess postural control. Anterior-posterior and medial-lateral CoP displacement will be analyzed during balance tasks.Unit of Measure: Millimeters (mm) or centimeters (cm)

    Time frame: Baseline (Week 0) and Post-intervention (Week 8)

  6. Postural Sway Parameters

    Postural sway characteristics, including CoP path length and CoP velocity, will be assessed during static and dynamic balance tasks using the Sensormedica system.Unit of Measure: Centimeters (cm), centimeters per second (cm/s)

    Time frame: Baseline (Week 0) and Post-intervention (Week 8)

  7. Lower Extremity Load Symmetry

    Load symmetry between the lower extremities will be evaluated during balance tasks using plantar pressure data obtained from the Sensormedica system. Unit of Measure: Percentage (%)

    Time frame: Baseline (Week 0) and Post-intervention (Week 8)

Secondary outcomes

  1. Mini-Balance Evaluation Systems Test

    The Mini-Balance Evaluation Systems Test (Mini-BESTest) is a clinical assessment tool primarily focused on evaluating dynamic balance. It is widely used to assess balance impairment and fall risk. The scale consists of 14 task items, representing the four major balance control systems derived from the original BESTest: anticipatory postural adjustments, reactive postural control, sensory orientation, and dynamic gait stability. The test includes functional tasks such as standing, rising onto the toes, single-leg stance, forward, backward, and lateral reactive stepping responses, gait speed changes, head turns during walking, obstacle negotiation, and timed walking tasks performed on foam surfaces and inclined surfaces with eyes closed, as well as walking with changes in gait pattern. Higher scores indicate better dynamic balance performance.

    Time frame: Baseline (Week 0) and Post-intervention (Week 8)

  2. Lower Extremity Muscle Strength (MicroFET 2 Handheld Dynamometer)

    Lower extremity muscle strength in older adults will be assessed using the MicroFET 2 Handheld Dynamometer . Muscle strength is defined as the maximum voluntary isometric contraction (MVIC) achieved under standardized testing conditions. For each muscle group, participants will perform three maximal voluntary contractions. During each trial, force will be gradually increased over 2 seconds and then maintained at the maximal level for 3 seconds. The highest recorded value will be used for analysis. The following muscle groups will be tested: 1. Knee extensor strength: Measured in the sitting position with the knee joint in extension. 2. Knee flexor strength: Measured in the prone position with the knee joint in flexion. 3. Ankle dorsiflexor strength: Measured in the sitting position with the ankle in dorsiflexion. 4. Ankle plantar flexor strength: Measured in the sitting position with the ankle in plantar flexion.

    Time frame: Baseline (Week 0) and Post-intervention (Week 8

  3. Four Square Step Test (FSST)

    The test assesses dynamic balance. As a clinical assessment, it is reliable and valid in older adults, easy to administer and score, quick to perform, requires minimal space, and does not require specialized equipment. Owing to its evaluation of movement in four directions and the inclusion of low-height obstacles (2.5 cm), it is considered a unique assessment tool (Dite \& Temple, 2002).

    Time frame: Baseline (Week 0) and Post-intervention (Week 8)

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2026 (actual). Primary completion is estimated for Dec 2026, 6 months after the start.

Of 492 non-industry interventional studies with no phase under Sarcopenia, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 34. This study's planned 6 months is below that.

Counting every sponsor, half of 503 studies reached it within 18 months; a quarter within 8 and three quarters within 34.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 12, 2026
First posted
Jan 22, 2026
StartActual
Jun 1, 2026
Primary completionEst.
Dec 30, 2026
CompletionEst.
Dec 30, 2027
Last update
Aug 11, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07357662
Lead sponsor
Tarsus University
Responsible party
Fatma Kübra ÇEKOK (Asst.prof, Tarsus University) — Principal investigator
First posted
Jan 22, 2026
Start date
Jun 1, 2026
Primary completion
Dec 30, 2026 (estimated)
Completion
Dec 30, 2027 (estimated)
Last update
Aug 11, 2026

Study contacts

FATMA Kübra ÇEKOK, Asst.Prof
Contact
kubracekok@tarsus.edu.tr
05434857545
Veysel Alcan, Assos.Prof
Contact
alcanveysel@tarsus.edu.tr

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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