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临床试验/NCT05002218
NCT05002218已完成不适用

The Neural Effects of Balance Versus Aerobic Training in Individuals With Degenerative Cerebellar Diseases

Columbia University1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2022年1月31日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
64
试验地点
1
主要终点
Change in Assessment and Rating of Ataxia (SARA) Score

研究概览

简要总结

Balance and aerobic training show promise as treatments for degenerative cerebellar diseases, but the neural effects of both training methods are unknown. The goal of this project is to evaluate how each training method impacts the brain, and particularly, the degenerating cerebellum. Various neuroimaging techniques will be used to accomplish this goal and test the hypothesis that balance training impacts brain structures outside the cerebellum whereas aerobic training causes more neuroplastic changes within the cerebellum.

详细描述

Degenerative cerebellar diseases are a group of disorders that cause severe disability and can be fatal. There are currently no known disease-modifying treatments available for use, and there is a critical need to find treatments that slow disease progression and allow affected individuals to live more functional lives. Balance and aerobic training show promise as treatments for degenerative cerebellar diseases, but the neural effects of both training methods have not been thoroughly investigated. It is crucial to understand how the training impacts the brain, and particularly the cerebellum, in order to determine if one training method is better at slowing disease progression than the other. The goal of this proposal is to compare the neural effects of balance versus aerobic training in individuals with degenerative cerebellar diseases. The investigator hypothesizes that aerobic training causes neuroplastic changes within the cerebellum whereas balance training causes improvements for people with cerebellar degeneration by impacting brain structures outside the cerebellum. If this hypothesis is true, aerobic training may have more influence on disease progression than balance training as it directly impacts the cerebellum.

To investigate the hypothesis, various neuroimaging techniques will be used. In AIM 1, the investigator will compare cerebellar volume before and after the participants perform either 6-months of balance or aerobic training. In AIM 2, the investigator will investigate whether neural changes have clinical significance by correlating cerebellar volume changes with clinical measures of ataxia. Finally, for AIM 3, the investigator will use diffusion tensor imaging and resting state fMRI scans to examine how both training methods impact cerebellar microstructure and functional cerebellar connections. The investigator hopes that a detailed understanding of how each training method impacts the cerebellum will lead to more targeted training regimens with the goal of slowing disease progression of these devastating diseases.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Care Provider, Outcomes Assessor)

盲法说明

Care providers and outcome assessor will not know which group individuals are assigned. In addition, the primary outcome will be video-recorded and the videos will be scrambled so that outcome assessor will not know if the test was done pre- or post-training.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosed with spinocerebellar ataxia
  • Cerebellar atrophy on MRI
  • Prevalence of ataxia on clinical exam
  • Ability to safely ride a stationary exercise bike

排除标准

  • Other neurologic conditions
  • Heart disease
  • Cognitive impairment
  • Medical instability

结局指标

主要结局

Change in Assessment and Rating of Ataxia (SARA) Score

时间窗: Baseline, 6 months, 9 months, 12 months

This is to measure ataxia severity. The Scale for the Assessment and Rating of Ataxia (SARA) will be administered before and after training. SARA is an 8-item performance based scale, yielding a total score of 0 (no ataxia) to 40 (most severe ataxia) - with higher scores indicating more severe ataxia. The scores are based on patient performance of gait, stance, sitting, speech disturbance, finger chase, nose-finger test, fast alternating hand movements and heel-shin slide. The change in score from baseline to 6 months, 9 months, and 12 months will be reported.

Change in Assessment and Rating of Ataxia (SARA) Score

时间窗: Baseline, 6 months, 9 months, 12 months

This is to measure ataxia severity. The Scale for the Assessment and Rating of Ataxia (SARA) will be administered before and after training. SARA is an 8-item performance based scale, yielding a total score of 0 (no ataxia) to 40 (most severe ataxia) - with higher scores indicating more severe ataxia. The scores are based on patient performance of gait, stance, sitting, speech disturbance, finger chase, nose-finger test, fast alternating hand movements and heel-shin slide. The change in score from baseline to 6 months, 9 months, and 12 months will be reported.

次要结局

  • Prevalence of Cerebellar Volume(Baseline, 6 months, 9 months, 12 months)
  • Average Gait Speed(Baseline, 6 months, 9 months, 12 months)
  • Dynamic Gait Index Score(Baseline, 6 months, 9 months, 12 months)
  • Timed Up and Go (TUG)(Baseline, 6 months, 9 months, 12 months)
  • Fatigue Severity Scale (FSS) Score(Baseline, 6 months, 9 months, 12 months)
  • Quality of Life (QOL) - Physical Health(Baseline, 6 months, 9 months, 12 months)
  • Quality of Life (QOL) - Psychological(Baseline, 6 months, 9 months, 12 months)
  • Quality of Life (QOL) - Social Relationships(Baseline, 6 months, 9 months, 12 months)
  • Quality of Life (QOL) - Environment(Baseline, 6 months, 9 months, 12 months)
  • Prevalence of Desired Changes in Diffuse Tensor Imaging(6 months)
  • Prevalence of Cerebellar Volume(Baseline, 6 months, 9 months, 12 months)
  • Prevalence of Desired Changes in Resting State fMRI Scans(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Scott Barbuto

Assistant Professor of Rehabilitation and Regenerative Medicine

Columbia University

研究点 (1)

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