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Cycling-Based Priming Coordination Training for Enhancing Ataxia Recovery and Brain Plasticity

The Effect of Cycling Priming Coordination Training on Ataxia and Brain Plasticity

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06600269
Enrollment
40
Registered
2024-09-19
Start date
2024-10-04
Completion date
2026-08-31
Last updated
2024-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinocerebellar Ataxias

Keywords

Transcranial Magnetic Stimulation (TMS), Gait, Motor Control, Motor Learning

Brief summary

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.

Interventions

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.

Sponsors

Chang Gung University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

\- Clinical diagnosis of SCA.

Exclusion criteria

* Musculoskeletal injuries on legs * Osteoporosis. * Any peripheral or central nervous system injury or disease patients.

Design outcomes

Primary

MeasureTime frameDescription
Sleep Quality Measurement Using Pittsburgh Sleep Quality Index (PSQI)Baseline, 2 weeks, and 4 weeksThe 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.
Total Berg Balance Scale (BBS) ScoreBaseline, 2 weeks, and 4 weeksTo 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.
Total Time to Complete the Time Up and Go test (TUG test)Baseline, 2 weeks, and 4 weeksThe 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.
Walking SpeedBaseline, 2 weeks, and 4 weeksThe time taken by participants to walk a standardized distance, typically expressed in centimeters per second (cm/s).
Step LengthBaseline, 2 weeks, and 4 weeksThe linear distance between the two ankles, typically expressed in centimeter(cm).
Step TimeBaseline, 2 weeks, and 4 weeksThe 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.
Fatigue Level Measurement Using Multidimensional Fatigue Inventory (MFI)Baseline, 2 weeks, and 4 weeksThe 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
Overall Response TimeBaseline, 2 weeks and 4 weeksThe 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)
Overall Error RateBaseline, 2 weeks and 4 weeksThe total proportion of incorrect responses across a testing session or series of tasks.
Motor Evoked Potentials (MEPs)Baseline, 2 weeks and 4 weeksMEPs 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).
Intracortical Facilitation (ICF)Baseline, 2 weeks and 4 weeksICF 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.
Intracortical Inhibition (ICI)Baseline, 2 weeks, and 4 weeksICI 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.
Total Scale for the Assessment and Rating of Ataxia (SARA) ScoreBaseline, 2 weeks, and 4 weeksTo 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).

Secondary

MeasureTime frameDescription
Gait Speed Measurement Using 10-Meter Walk Test (10MWT)Baseline, 2 weeks, and 4 weeksThe 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).
Double Support TimeBaseline, 2 weeks, and 4 weeksThe 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.
Single Support TimeBaseline, 2 weeks, and 4 weeksThe 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.
Swing TimeBaseline, 2 weeks, and 4 weeksThe 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.
CadenceBaseline, 2 weeks, and 4 weeksThe number of steps an individual takes per minute, providing an overview of gait speed and rhythm, , expressed as steps per minute.
Stance TimeBaseline, 2 weeks, and 4 weeksThe 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

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026