ClinicalTrials.gg
RecruitingNCT06600269Updated Oct 8, 2024

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

An interventional study of Cycling Training in Spinocerebellar Ataxias, sponsored by Chang Gung University. Recruiting at 1 site in Taiwan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-08.

Sponsored by Chang Gung University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Aug 2026, 3 months ago, but the record still lists the study as recruiting.
  • Started Oct 2024; still recruiting 2 years 1 month later.

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Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 10 studies in Spinocerebellar Ataxias with a site in Taiwan — 4 open to participants now, 5 under way, none of them phase 3. Spinocerebellar Ataxias · Taiwan.

Planned enrollment
4th of 10
40 · median 40
Started
2024
with 2 others
No phase
7 of 10
4 open now
Registered
8th of 10
by date
Lead sponsor
5 of 10
Chang Gung University

Among the 10 studies in Spinocerebellar Ataxias with a site in Taiwan, this one is the 4th largest by planned enrollment, is one of 3 that started in 2024, is one of 7 with no phase, and was the 8th registered.

Spinocerebellar Ataxias

95 studies on the registry are indexed under Spinocerebellar Ataxias; 25 are open to participants now.

Browse Spinocerebellar Ataxias studies →

Open to participants now

4 of the 10 studies in Spinocerebellar Ataxias with a site in Taiwan are open now. Recruiting first, the newest first:

All 4 open studies →

A study can be open while its sites in Taiwan have not opened yet or have stopped. Only those recruiting at a site in Taiwan →

Who these studies take

Of the 16 Spinocerebellar Ataxias studies recruiting now, 8 (50%) set no upper age limit and 3 (19%) stop at 75 or younger; 4 take children under 18; 5 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study 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.

03

Conditions studied

  • Spinocerebellar Ataxias

Keywords

  • Transcranial Magnetic Stimulation (TMS)
  • Gait
  • Motor Control
  • Motor Learning
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Clinical diagnosis of SCA.

Exclusion criteria

Exclusion Criteria:

  • Musculoskeletal injuries on legs
  • Osteoporosis.
  • Any peripheral or central nervous system injury or disease patients.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    SCA training group

    Long-term training

    Procedure: Cycling Training

  • No intervention
    SCA Control group

    Control group

Interventions

  • ProcedureCycling Training

    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.

06

What researchers measure

Primary outcomes

  1. Overall Response Time

    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

  2. Overall Error Rate

    The total proportion of incorrect responses across a testing session or series of tasks.

    Time frame: Baseline, 2 weeks and 4 weeks

  3. Motor Evoked Potentials (MEPs)

    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

  4. Intracortical Facilitation (ICF)

    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

  5. Intracortical Inhibition (ICI)

    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

  6. Total Scale for the Assessment and Rating of Ataxia (SARA) Score

    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

  7. Total Berg Balance Scale (BBS) Score

    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

  8. Total Time to Complete the Time Up and Go test (TUG test)

    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

  9. Walking Speed

    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

  10. Step Length

    The linear distance between the two ankles, typically expressed in centimeter(cm).

    Time frame: Baseline, 2 weeks, and 4 weeks

  11. Step Time

    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

  12. Fatigue Level Measurement Using Multidimensional Fatigue Inventory (MFI)

    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

  13. Sleep Quality Measurement Using Pittsburgh Sleep Quality Index (PSQI)

    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

Secondary outcomes

  1. Gait Speed Measurement Using 10-Meter Walk Test (10MWT)

    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

  2. Double Support Time

    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

  3. Single Support Time

    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

  4. Swing Time

    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

  5. Stance Time

    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

  6. Cadence

    The number of steps an individual takes per minute, providing an overview of gait speed and rhythm, , expressed as steps per minute.

    Time frame: Baseline, 2 weeks, and 4 weeks

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2024 (actual). Primary completion is estimated for Aug 2026, 22 months after the start.

Of 28 interventional studies with no phase under Spinocerebellar Ataxias, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 30. This study's planned 22 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 13, 2024
First posted
Sep 19, 2024
StartActual
Oct 4, 2024
Primary completionEst.
Aug 2026
CompletionEst.
Aug 2026
Last update
Oct 8, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 8, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06600269
Lead sponsor
Chang Gung University
Responsible party
Ya-Ju Chang (Professor, Chang Gung University) — Principal investigator
First posted
Sep 19, 2024
Start date
Oct 4, 2024
Primary completion
Aug 2026 (estimated)
Completion
Aug 2026 (estimated)
Last update
Oct 8, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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