An interventional study of Nintendo Wii Fit Balance Exergame Training and Conventional Balance Training in Falls (Accidents) in Old Age, sponsored by Mahidol University. Recruiting at 1 site in Thailand. Open to participants aged 65 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Mahidol University · Not applicable, Interventional, and Other
Falls are a major health concern among older adults and can affect mobility, independence, and quality of life. Balance training is commonly used to improve postural control and reduce fall risk. However, conventional balance training mainly focuses on physical movement, whereas balance exergames combine physical exercise with cognitive challenges that may help improve both motor control and executive function.
This study aims to investigate the effectiveness of balance exergame training on cortical excitability, cortical inhibition, and functional performance in older adults with a history of falls.
A total of 42 Thai older adults aged 65-85 years with at least one fall during the previous 12 months will be recruited and randomly assigned to one of two groups: a balance exergame group or a conventional balance training group.
The balance exergame group will participate in game-based balance training using Nintendo Wii Fit, including Ski Slalom, Table Tilt, Tightrope Tension, Balance Bubble, and Penguin Slide. Participants will perform weight-shifting activities on a balance board while responding to visual and auditory challenges during gameplay. The conventional balance training group will perform structured balance exercises involving sitting, standing, and walking activities.
Both groups will participate in supervised training sessions lasting 60 minutes, three times per week, for eight weeks. Participants will undergo assessments before and after the intervention period.
Study outcomes will include fear of falling, cognitive function, executive function, balance and movement performance, and neurophysiological measures of cortical excitability and inhibition assessed using transcranial magnetic stimulation (TMS). Additional assessments will examine sensory function and biomechanical characteristics of movement.
The findings are expected to provide further understanding of the effects of balance exergame training on brain function and functional performance in older adults with a history of falls.
Mahidol University is the lead sponsor of 747 studies on the registry; 119 are open to participants now.
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Exclusion Criteria:
Participants will undergo an 8-week conventional balance training program consisting of supervised 60-minute sessions, three times per week. Each session includes a 5-minute warm-up with lower-limb stretching, 50 minutes of balance training, and a 5-minute cool-down. Balance training comprises sitting exercises (15-20 minutes), including maintaining balance on a Swiss ball and performing arm and leg movements, throwing and catching a ball, and kicking a ball; standing exercises (15-20 minutes), including standing balance activities and standing on a foam pad or cushion; and walking exercises (15-20 minutes), including marching in place, walking lunges, zigzag walking, obstacle navigation, and walking while performing cognitive or carrying tasks.
Behavioral: Conventional Balance Training
Participants will undergo an 8-week balance exergame training program using the Nintendo Wii Fit platform and balance board. The available games include Ski Slalom, Table Tilt, Tightrope Tension, Balance Bubble, and Penguin Slide. Participants will stand barefoot on the balance board and perform multidirectional weight-shifting activities to challenge postural stability. Participants may select any available game during each training session. Training will consist of supervised 60-minute sessions, three times per week, for eight weeks.
Behavioral: Nintendo Wii Fit Balance Exergame Training
An 8-week structured balance exergame training program using the Nintendo Wii Fit platform and balance board. Participants perform barefoot multidirectional weight-shifting exercises using five available games: Ski Slalom, Table Tilt, Tightrope Tension, Balance Bubble, and Penguin Slide. Participants may choose any available game during each session. Each supervised 60-minute session consists of a 5-minute lower-limb stretching warm-up, 50 minutes of balance exergame training, and a 5-minute cool-down with stretching exercises. Training is conducted three times per week for eight weeks. A researcher oversees the intervention, and participants may take breaks as needed.
An 8-week structured conventional balance training program consisting of supervised 60-minute sessions, three times per week. Each session includes a 5-minute warm-up with lower-limb stretching, 50 minutes of balance training, and a 5-minute cool-down. The balance training comprises three components: (1) Sitting balance training (15-20 minutes), including sitting on a Swiss ball to maintain balance, moving the arms or legs, throwing and catching a ball, and kicking a ball; (2) Standing balance training (15-20 minutes), including standing with feet together, shifting body weight side to side, standing on one leg, throwing and catching a ball, and standing on a foam pad or cushion; and (3) Walking training (15-20 minutes), including marching in place, walking lunges, zigzag walking, obstacle navigation, walking on a foam pad, cognitive dual-task walking, and walking while carrying a tray of water. Training intensity is adjusted according to each participant's capability.
Fear of Falling (FES-I)
The Falls Efficacy Scale-International (FES-I) is a 16-item questionnaire assessing participants' concerns about falling during daily activities. Each item is scored on a 4-point Likert scale. Total scores range from 16 to 64, with higher scores indicating greater fear of falling.
Time frame: Baseline (Week 0) and post-intervention (Week 9)
Montreal Cognitive Assessment (MoCA)
Cognitive function is assessed using the Montreal Cognitive Assessment (MoCA), covering memory, language, attention, visuospatial function, executive function, and calculation. The total score ranges from 0 to 30, with higher scores indicating better cognitive performance.
Time frame: Baseline (Week 0) and post-intervention (Week 9)
Forward Digit Span Test
The time required to complete the forward Digit Span test is recorded in seconds (sec). This assessment evaluates the time required to perform the forward digit repetition task.
Time frame: Baseline (Week 0) and post-intervention (Week 9)
Percentage of Correct Responses in the Forward Digit Span Test
Cognitive performance is evaluated using the forward Digit Span test. The percentage of correct responses (%) is recorded to assess performance in the forward digit repetition task.
Time frame: Baseline (Week 0) and post-intervention (Week 9)
Backward Digit Span Test
The time required to complete the backward Digit Span test is recorded in seconds (sec). This assessment evaluates the time required to perform the backward digit repetition task.
Time frame: Baseline (Week 0) and post-intervention (Week 9)
Percentage of Correct Responses in the Backward Digit Span Test
Cognitive performance is evaluated using the backward Digit Span test. The percentage of correct responses (%) is recorded to assess performance in the backward digit repetition task.
Time frame: Baseline (Week 0) and post-intervention (Week 9)
Stroop Test
The time required to complete the Stroop test is recorded in seconds (sec) to evaluate the time required to perform the cognitive task involving attention and inhibitory control.
Time frame: Baseline (Week 0) and post-intervention (Week 9)
Percentage of Correct Responses in the Stroop Test
Cognitive performance is evaluated using the Stroop test. The percentage of correct responses (%) is recorded to assess attention and inhibitory control performance.
Time frame: Baseline (Week 0) and post-intervention (Week 9)
Sway Area During Functional Performance Assessments
Postural movement is evaluated using a marker-based three-dimensional motion capture system (Vicon). Sway area is calculated from the recorded movement trajectories during functional performance assessments and expressed in square centimeters (cm²).
Time frame: Baseline (Week 0) and post-intervention (Week 9)
Acceleration Time During Functional Performance
Movement acceleration time is evaluated using biomechanical data obtained from a marker-based three-dimensional motion capture system during functional performance assessments. Acceleration time is recorded in seconds (sec).
Time frame: Baseline (Week 0) and post-intervention (Week 9)
Deceleration Time During Functional Performance
Movement deceleration time is evaluated using biomechanical data obtained from a marker-based three-dimensional motion capture system during functional performance assessments. Deceleration time is recorded in seconds (sec).
Time frame: Baseline (Week 0) and post-intervention (Week 9)
Foot Clearance During Functional Performance
Foot clearance is evaluated using marker-based three-dimensional motion capture during functional performance assessments. The vertical clearance of the foot during movement is recorded in millimeters (mm).
Time frame: Baseline (Week 0) and post-intervention (Week 9)
Cortical Silent Period (CSP) Duration
Cortical inhibition is assessed using transcranial magnetic stimulation (TMS). Single-pulse TMS is delivered at 130% of resting motor threshold while participants maintain approximately 20% maximum voluntary contraction. CSP duration is measured as the interval between the end of the motor-evoked potential and the resumption of baseline muscle activity, expressed in seconds.
Time frame: Baseline (Week 0) and post-intervention (Week 9)
Change in Short-Interval Intracortical Inhibition (SICI) Threshold
Intracortical inhibition is assessed using paired-pulse transcranial magnetic stimulation (TMS). The change (Δ) in the threshold of short-interval intracortical inhibition is evaluated and expressed as a percentage (%). This parameter represents the SICI threshold change specified as a primary outcome in the study protocol.
Time frame: Baseline (Week 0) and post-intervention (Week 9)
Central Motor Conduction Time (CMCT)
Central motor conduction time is assessed using peripheral nerve stimulation and measurement of M-waves and F-waves. The measurements are used to evaluate motor pathway conduction. CMCT is recorded in seconds (sec).
Time frame: Baseline (Week 0) and post-intervention (Week 9)
Cold Detection Threshold (CDT)
Cold detection threshold is assessed using quantitative sensory testing (QST) with an air-cooled probe applied to the dorsum of the right foot. The baseline temperature is set at 32°C, and the cold detection threshold is determined using the standardized 4-2-1 stepping algorithm. Results are expressed in degrees Celsius (°C).
Time frame: Baseline (Week 0) and post-intervention (Week 9)
Vibration Detection Threshold (VDT)
Vibration detection threshold is assessed using quantitative sensory testing (QST). A vibration stimulus probe is applied to the right metatarsal bone, and the detection threshold is determined using the standardized 4-2-1 stepping algorithm. Results are expressed in micrometers (µm).
Time frame: Baseline (Week 0) and post-intervention (Week 9)
Lower-Limb Angular Velocity During Walking
Lower-limb angular velocity is evaluated during walking using a marker-based three-dimensional motion capture system. Angular velocity is calculated from the recorded lower-limb movement data and expressed in degrees per second (°/sec).
Time frame: Baseline (Week 0) and post-intervention (Week 9)
Resting Motor Threshold (RMT)
Resting motor threshold is assessed using transcranial magnetic stimulation (TMS). It is defined as the minimum stimulation intensity required to elicit a motor-evoked potential greater than 50 µV in at least 5 of 10 consecutive trials while the target muscle is relaxed. Results are expressed as a percentage (%) of maximum stimulator output.
Time frame: Baseline (Week 0) and post-intervention (Week 9)
Active Motor Threshold (AMT)
Active motor threshold is assessed using transcranial magnetic stimulation (TMS) while participants maintain a 10-20% maximum voluntary contraction. It is defined as the minimum stimulation intensity required to elicit a motor-evoked potential greater than 200 µV in at least 5 of 10 consecutive trials. Results are expressed as a percentage (%) of maximum stimulator output.
Time frame: Baseline (Week 0) and post-intervention (Week 9)
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