Spinocerebellar AtaxiasNCT06600269
Cycling-Based Priming Coordination Training for Enhancing Ataxia Recovery and Brain Plasticity
A study testing Cycling Training in people with Spinocerebellar Ataxias, run by Chang Gung University at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinocerebellar Ataxias
- What is being tested?
- Cycling Training
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 4 Oct 2024to Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of SCA.
Who cannot join
- Musculoskeletal injuries on legs
- Osteoporosis.
- Any peripheral or central nervous system injury or disease patients.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung University
Taoyuan, 333
Ya-Ju Chang, PhD, 88632118800 ext. 5515, yjchang@mail.cgu.edu.tw
About this study
Official title: The Effect of Cycling Priming Coordination Training on Ataxia and Brain Plasticity
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.
Read more
This clinical trial aims to:
- Investigate the priming effect and neural mechanisms of acute cycling exercise on coordination training in patients with SCA.
- 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.
- Conditions
- Spinocerebellar Ataxias
- Being tested
- Cycling Training
- Keywords
- Transcranial Magnetic Stimulation (TMS), Gait, Motor Control, Motor Learning
- Medical subject headings
- Spinocerebellar Ataxias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cycling TrainingProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| SCA training group | Experimental | Long-term training Receives: Procedure: Cycling Training |
| SCA Control group | No intervention | Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline, 2 weeks and 4 weeks
Overall Error Rate
The total proportion of incorrect responses across a testing session or series of tasks.
Measured: Baseline, 2 weeks and 4 weeks
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).
Measured: Baseline, 2 weeks and 4 weeks
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.
Measured: Baseline, 2 weeks and 4 weeks
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.
Measured: Baseline, 2 weeks, and 4 weeks
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).
Measured: Baseline, 2 weeks, and 4 weeks
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.
Measured: Baseline, 2 weeks, and 4 weeks
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.
Measured: Baseline, 2 weeks, and 4 weeks
Walking Speed
The time taken by participants to walk a standardized distance, typically expressed in centimeters per second (cm/s).
Measured: Baseline, 2 weeks, and 4 weeks
Step Length
The linear distance between the two ankles, typically expressed in centimeter(cm).
Measured: Baseline, 2 weeks, and 4 weeks
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.
Measured: Baseline, 2 weeks, and 4 weeks
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
Measured: Baseline, 2 weeks, and 4 weeks
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.
Measured: Baseline, 2 weeks, and 4 weeks
Secondary outcomes (6)
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).
Measured: Baseline, 2 weeks, and 4 weeks
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.
Measured: Baseline, 2 weeks, and 4 weeks
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.
Measured: Baseline, 2 weeks, and 4 weeks
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.
Measured: Baseline, 2 weeks, and 4 weeks
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
Measured: Baseline, 2 weeks, and 4 weeks
Cadence
The number of steps an individual takes per minute, providing an overview of gait speed and rhythm, , expressed as steps per minute.
Measured: Baseline, 2 weeks, and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start4 Oct 2024
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinocerebellar AtaxiasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ya-Ju Chang, Chang Gung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06600269
- Sponsor's protocol ID
- SCA_001
- Status last verified
- Oct 2024
- First submitted
- 13 Sep 2024
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cycling Priming Coordination Training on Ataxia and Brain Plasticity
- ClinicalTrials.gov ID
- NCT06600269
- Acronym / sponsor ID
- SCA_001
- Conditions
- Spinocerebellar Ataxias
- Keywords
- Transcranial Magnetic Stimulation (TMS), Gait, Motor Control, Motor Learning
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Chang Gung UniversityUniversity, hospital or other
- Study start
- 4 Oct 2024 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Investigate the priming effect and neural mechanisms of acute cycling exercise on coordination training in patients with SCA.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SCA training group | Experimental | Procedure: Cycling TrainingLong-term training |
| SCA Control group | No intervention | –Control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of SCA.
Key exclusion criteria (3 listed)
- Musculoskeletal injuries on legs
- Osteoporosis.
- Any peripheral or central nervous system injury or disease patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cycling TrainingCycling 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. | Procedure or surgery | SCA training group |
Primary outcome
Overall Response Time
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)
Overall Error Rate
Time frame: Baseline, 2 weeks and 4 weeks
The total proportion of incorrect responses across a testing session or series of tasks.
Motor Evoked Potentials (MEPs)
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).
Intracortical Facilitation (ICF)
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.
Intracortical Inhibition (ICI)
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.
Total Scale for the Assessment and Rating of Ataxia (SARA) Score
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).
Total Berg Balance Scale (BBS) Score
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.
Total Time to Complete the Time Up and Go test (TUG test)
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.
Walking Speed
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).
Step Length
Time frame: Baseline, 2 weeks, and 4 weeks
The linear distance between the two ankles, typically expressed in centimeter(cm).
Step Time
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.
Fatigue Level Measurement Using Multidimensional Fatigue Inventory (MFI)
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
Sleep Quality Measurement Using Pittsburgh Sleep Quality Index (PSQI)
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.
6 secondary outcomes
Gait Speed Measurement Using 10-Meter Walk Test (10MWT)
Time frame: Baseline, 2 weeks, and 4 weeks
Double Support Time
Time frame: Baseline, 2 weeks, and 4 weeks
Single Support Time
Time frame: Baseline, 2 weeks, and 4 weeks
Swing Time
Time frame: Baseline, 2 weeks, and 4 weeks
Stance Time
Time frame: Baseline, 2 weeks, and 4 weeks
Cadence
Time frame: Baseline, 2 weeks, and 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cycling Training in people with Spinocerebellar Ataxias, run by Chang Gung University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Time (time frame: Baseline, 2 weeks and 4 weeks). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024.