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

NCT07357662 | Not Yet Recruiting

• 1 other identifier: Tarsus U
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (7)

• 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.

  Baseline (Pre-intervention assessment, Week 0)

• 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)

  baseline and 8 weeks later

• 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%.

  Baseline (Week 0) and Post-intervention (8 Week )

• 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)

  Baseline (Week 0) and Post-intervention (Week 8)

• 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)

  Baseline (Week 0) and Post-intervention (Week 8)

• 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)

  Baseline (Week 0) and Post-intervention (Week 8)

• 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 (%)

  Baseline (Week 0) and Post-intervention (Week 8)

Secondary Outcomes (3)

• Mini-Balance Evaluation Systems Test

  Baseline (Week 0) and Post-intervention (Week 8)

• Lower Extremity Muscle Strength (MicroFET 2 Handheld Dynamometer)

  Baseline (Week 0) and Post-intervention (Week 8

• Four Square Step Test (FSST)

  Baseline (Week 0) and Post-intervention (Week 8)

Study Arms (2)

Exergame-based Balance and Foot Muscle Training

EXPERIMENTAL

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

Functional balance training

ACTIVE COMPARATOR

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

Exergame-based Balance and Foot Muscle Training OTHER

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

Exergame-based Balance and Foot Muscle Training

Conventional Functional Balance Training OTHER

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

Functional balance training

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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 Mini-Mental State Examination (MMSE) score ≥26

You may not qualify if:

• Body mass index (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 malignancy 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

Sponsors & Collaborators

• Tarsus University: lead

Study Sites (1)

Fatma kübra çekok

Tarsus, Mersin, 33400, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sarcopenia; Motor Activity

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Behavior

Central Study Contacts

FATMA Kübra ÇEKOK, Asst.Prof

CONTACT

05434857545; kubracekok@tarsus.edu.tr

Veysel Alcan, Assos.Prof

CONTACT

alcanveysel@tarsus.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst.prof

Model Details: randomized controlled trial

Study Record Dates

• First Submitted: January 12, 2026
• First Posted: January 22, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2027
• Last Updated: January 22, 2026

Record last verified: 2026-01

Locations

TU (1)