Chang Gung University
Taoyuan, 333, Taiwan
Location status: Recruiting
NCT Number: NCT06600269
Effective walking and balance require not only lower limb muscle strength but also coordinated movement. For individuals with Spinocerebellar Ataxia (SCA), rehabilitation strategies targeting coordination are essential to improving mobility and reducing the burden on caregivers. However, evidence-based rehabilitation approaches for ataxia remain limited.
Recent studies suggest that improvements in motor learning are often accompanied by changes in cortical excitability. Abnormal cortical excitability in SCA patients may hinder rehabilitation efforts, yet priming strategies-such as exercise or specific stimuli-have been shown to enhance motor learning by modulating cortical excitability. Cycling exercise, in particular, has demonstrated the potential to improve coordination and influence cortical plasticity in individuals with SCA, making it a promising priming strategy for coordination training.
This clinical trial aims to:
1. Investigate the priming effect and neural mechanisms of acute cycling exercise on coordination training in patients with SCA. 2. Explore the long-term impact of priming cycling training on cortical plasticity and functional mobility in individuals with SCA.
This study seeks to provide insights into optimized rehabilitation interventions that could enhance the quality of life and independence for people with SCA.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Taoyuan, 333, Taiwan
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Cycling combined with priming strategies to enhance motor learning tasks. Each session will last for 15 minutes, conducted three times per week, over a period of two weeks.
Time frame: Baseline, 2 weeks and 4 weeks
The sum of reaction time and movement time, providing a complete measure of the time taken from the stimulus presentation to the completion of the response. Unit: Second(s)
Time frame: Baseline, 2 weeks and 4 weeks
The total proportion of incorrect responses across a testing session or series of tasks.
Time frame: Baseline, 2 weeks and 4 weeks
MEPs are the electrical responses recorded from muscles following stimulation of the motor cortex. They reflect the efficiency of neural transmission from the cortex to the muscle. Unit: millivolts (mV).
Time frame: Baseline, 2 weeks and 4 weeks
ICF is measured by applying a pair of TMS pulses with a short interval (e.g., 8-15 ms) where the first (subthreshold) pulse is followed by a second (suprathreshold) pulse, leading to an increased amplitude of the MEP.
Time frame: Baseline, 2 weeks, and 4 weeks
ICI is measured similarly to ICF but with a shorter inter-stimulus interval (e.g., 1-5 ms), resulting in a suppressed MEP amplitude. This suppression reflects inhibitory processes within the cortex.
Time frame: Baseline, 2 weeks, and 4 weeks
To objectively assess ataxia severity across various domains of motor function including gait, stance, sitting, speech disturbance, finger chase, nose-finger test, fast alternating hand movements, and heel-shin slide. Each item is scored individually with a scale that typically ranges from 0 (no ataxia) to a maximum score that depends on the severity and the aspect of ataxia being assessed. The total score ranges from 0 (no ataxia) to 40 (most severe ataxia).
Time frame: Baseline, 2 weeks, and 4 weeks
To measure an individual's balance abilities through various tasks that mimic daily activities, assessing the risk of falls and overall balance proficiency. The BBS consists of 14 items that evaluate a range of functions including sitting to standing, standing unsupported, transferring, turning to look behind, picking up an object from the floor, and standing on one leg. Each task is rated on a scale from 0 (unable) to 4 (independent), with the total score ranging from 0 to 56. A higher total score indicates better balance and lower fall risk. Scores below 45 are generally indicative of increased fall risk.
Time frame: Baseline, 2 weeks, and 4 weeks
The time, in seconds, it takes for a participant to complete the TUG test from the initial sitting position to returning to the seated position. An older adult who takes ≥12 seconds to complete the TUG is at risk for falling.
Time frame: Baseline, 2 weeks, and 4 weeks
The time taken by participants to walk a standardized distance, typically expressed in centimeters per second (cm/s).
Time frame: Baseline, 2 weeks, and 4 weeks
The linear distance between the two ankles, typically expressed in centimeter(cm).
Time frame: Baseline, 2 weeks, and 4 weeks
The duration taken for one complete step, measuring from foot-off of one foot to the next foot-off of the same foot, usually expressed in seconds.
Time frame: Baseline, 2 weeks, and 4 weeks
The MFI is a 20-item self-report questionnaire used to measure five dimensions of fatigue: general fatigue, physical fatigue, mental fatigue, reduced activity, and reduced motivation. Each dimension is scored separately, with higher scores indicating greater fatigue
Time frame: Baseline, 2 weeks, and 4 weeks
The PSQI is a 19-item self-report questionnaire that assesses sleep quality over a 1-month period. It generates a global score ranging from 0 to 21, with higher scores indicating poorer sleep quality. The PSQI includes seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction.
Time frame: Baseline, 2 weeks, and 4 weeks
The 10MWT is a performance-based measure used to assess walking speed over a short distance. Participants will be instructed to walk 10 meters at their comfortable and/or fastest walking speed. The time taken to walk the central 6 meters is recorded to eliminate acceleration and deceleration effects, and gait speed is calculated as meters per second (m/s).
Time frame: Baseline, 2 weeks, and 4 weeks
The portion of the gait cycle where both feet are in contact with the ground, indicating the transition phase between steps, expressed as a percentage of the gait cycle or in seconds.
Time frame: Baseline, 2 weeks, and 4 weeks
The duration within the gait cycle when only one foot is in contact with the ground, typically measured in seconds or as a percentage of the total gait cycle.
Time frame: Baseline, 2 weeks, and 4 weeks
The portion of the gait cycle where the foot is not in contact with the ground, moving forward to the next step. It is usually expressed as a percentage of the total gait cycle or in seconds.
Time frame: Baseline, 2 weeks, and 4 weeks
The portion of the gait cycle when the foot is in contact with the ground, supporting body weight. It's typically expressed as a percentage of the total gait cycle or in seconds
Time frame: Baseline, 2 weeks, and 4 weeks
The number of steps an individual takes per minute, providing an overview of gait speed and rhythm, , expressed as steps per minute.
Chang Gung University
Other
The Effect of Cycling Priming Coordination Training on Ataxia and Brain Plasticity
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