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Clinical Trials/NCT06600269
NCT06600269
Recruiting
Not Applicable

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

Chang Gung University1 site in 1 country40 target enrollmentOctober 4, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Spinocerebellar Ataxias
Sponsor
Chang Gung University
Enrollment
40
Locations
1
Primary Endpoint
Overall Response Time
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 4, 2024
End Date
August 2026
Last Updated
last year
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ya-Ju Chang

Professor

Chang Gung University

Eligibility Criteria

Inclusion Criteria

  • Clinical diagnosis of SCA.

Exclusion Criteria

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • 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)
  • Cadence(Baseline, 2 weeks, and 4 weeks)

Study Sites (1)

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