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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65-80
SponsorTarsus University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Exergame-based Balance and Foot Muscle Training

    Other intervention

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

  • Conventional Functional Balance Training

    Other intervention

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

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Exergame-based Balance and Foot Muscle TrainingExperimental treatment 1 intervention
Group B: Functional balance trainingActive comparator 1 intervention

Trial outcomes

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)

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)

Other outcomes

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