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

NCT06600269 | Recruiting

• 1 other identifier: SCA_001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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. 1.Investigate the priming effect and neural mechanisms of acute cycling exercise on coordination training in patients with SCA.
2. 2.Explore the long-term impact of priming cycling training on cortical plasticity and functional mobility in individuals with SCA.

Conditions

Spinocerebellar Ataxias

Keywords

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

Outcome Measures

Primary Outcomes (13)

• 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)

  Baseline, 2 weeks and 4 weeks

• Overall Error Rate

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

  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).

  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.

  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.

  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).

  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.

  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.

  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).

  Baseline, 2 weeks, and 4 weeks

• Step Length

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

  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.

  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

  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.

  Baseline, 2 weeks, and 4 weeks

Secondary Outcomes (6)

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

  Baseline, 2 weeks, and 4 weeks

• Double Support Time

  Baseline, 2 weeks, and 4 weeks

• Single Support Time

  Baseline, 2 weeks, and 4 weeks

• Swing Time

  Baseline, 2 weeks, and 4 weeks

• Stance Time

  Baseline, 2 weeks, and 4 weeks

Study Arms (2)

SCA training group

EXPERIMENTAL

Long-term training

Procedure: Cycling Training

SCA Control group

NO INTERVENTION

Control group

Interventions

Cycling Training PROCEDURE

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.

SCA training group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Clinical diagnosis of SCA.

You may not qualify if:

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

Sponsors & Collaborators

• Chang Gung University: lead

Study Sites (1)

Chang Gung University

Taoyuan District, 333, Taiwan

RECRUITING

MeSH Terms

Conditions

Spinocerebellar Ataxias

Condition Hierarchy (Ancestors)

Cerebellar Ataxia; Cerebellar Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinocerebellar Degenerations; Spinal Cord Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Ataxia; Dyskinesias; Neurologic Manifestations; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 13, 2024
• First Posted: September 19, 2024
• Study Start: October 4, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: October 8, 2024

Record last verified: 2024-10

Locations

TW (1)