Evaluation of the Effects of Rehabilitative Exergame Exercises on Foot Muscle Activation, Balance, and Mobility in Older Adults Using Surface Electromyography and Postural Sway Measurements
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Standardized Mini-Mental State Examination (SMMSE).
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 65 Years 至 80 Years(Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Exergame-based Balance and Foot Muscle Training (Other)
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.
干预措施: Conventional Functional Balance Training (Other)
结局指标
主要结局
Standardized Mini-Mental State Examination (SMMSE).
时间窗: Baseline (Pre-intervention assessment, Week 0)
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.
Surface EMG Frequency-Domain Parameters During Functional Reach Test
时间窗: baseline and 8 weeks later
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)
Timed Up and Go Test (TUG)
时间窗: Baseline (Week 0) and Post-intervention (8 Week )
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%.
Electrophysiological Measurements Using Surface EMG
时间窗: Baseline (Week 0) and Post-intervention (Week 8)
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)
Center of Pressure (CoP) Displacement
时间窗: Baseline (Week 0) and Post-intervention (Week 8)
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)
Postural Sway Parameters
时间窗: Baseline (Week 0) and Post-intervention (Week 8)
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)
Lower Extremity Load Symmetry
时间窗: Baseline (Week 0) and Post-intervention (Week 8)
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 (%)
次要结局
- 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))
研究者
Fatma Kübra ÇEKOK
Asst.prof
Tarsus University
