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临床试验/NCT03879018
NCT03879018招募中不适用

Retraining Reaching in Cerebellar Ataxia

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2019年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
18
试验地点
2
主要终点
Hand path distance during natural reaching to the trained target locations.

研究概览

简要总结

The purpose of this study is to test for benefits of reinforcement based training paradigm versus standard practice over weeks for improving reaching movements in people with ataxia.

详细描述

Damage to the cerebellum produces characteristic deficits in movement coordination, known as "ataxia." Reaching movements become curved, tremulous, and over- or undershoot targets, thus affecting nearly all activities of daily living. Sitting and standing balance becomes unsteady, and walking has a characteristic 'drunken' appearance with lateral veering and a widening of the base of support. People with many types of neurological diseases (e.g. autosomal dominant ataxias (e.g. SCAs), multiple sclerosis, cerebral palsy, stroke, Freidreich's ataxia) often have disabling ataxia.

In past work the investigators have shown that many individuals with ataxia from cerebellar disease can learn simple visuomotor tasks using reinforcement learning paradigms. The investigators do not know if individuals with ataxia from cerebellar disease can improve more complex motor patterns. In general, there are few rehabilitation studies on ataxia, with most focusing on balance and walking. Yet, arm ataxia is a significant problem that affects most all activities of daily living (e.g. eating, cooking, bathing, dressing, working). Many studies have assessed reaching ataxia on single days in order to try to better understand the fundamental basis for ataxic arm movements. Based on previous literary searches, there are only a couple of small studies that have tested whether training over weeks can mitigate arm ataxia. Each of these was a case series of either 3 or 4 people, and all patients had ataxia from lesions that included structures outside of the cerebellum. Both showed some positive effects but responses varied across patients. This work that the investigators propose will look at the affects of a longer training regimen of upper limb reaching in people with cerebellar ataxia.

The investigators will study cerebellar patients that have shown the ability to learn from previous work. Subjects with cerebellar ataxia will be randomized into two groups to receive either reinforcement training or standard practice training over a 12 week period. Subjects will train for 45 minutes a day, 3 times per week for two weeks for each type of training, with a two week 'rest' period in between. After training, subjects will be asked to return for two visits to test for retention. On each training day, reinforcement training (or standard practice) will be done using an Oculus Rift and Touch 3D headset. Training encompasses reaching to a 3D target with either online visual feedback or binary feedback 400 times. Motion tracking sensors will be placed on the shoulder, elbow, wrist, and finger, in order to track movement data in real time. These studies will provide important new information about upper limb long term training with visual feedback in individuals with Cerebellar Ataxia

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
22 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Cerebellar damage from stroke, tumor or degeneration
  • Age 22-80

排除标准

  • Clinical or MRI evidence of damage to extracerebellar brain (e.g. multiple system atrophy)
  • Extrapyramidal symptoms, peripheral vestibular loss, or sensory neuropathy
  • Dementia ( Mini-Mental State exam > 22)
  • Pain that interferes with the tasks
  • Vision loss that interferes with the tasks

研究组 & 干预措施

Reinforcement Training

Experimental

Reach training with visual feedback. During each training session, participants will first be familiarized with the task and then will reach from a home position to 4 virtual targets that are presented in the front of the participant and within the workspace where most natural arm movements are performed. During training the participant will reach a total of 400 times. For reinforcement training, participants will not see their hand or a cursor, but instead participants will receive target-specific binary feedback after each reach (i.e. based on running average of last 10 reaches to that target). Binary feedback indicates only whether the reach was successful or unsuccessful and provides no specific information about the location of the hand.

干预措施: Reach training with visual feedback (Behavioral)

Standard Practice Training

Experimental

Reach training with visual feedback. During each training session, participants will first be familiarized with the task and then will reach from a home position to 4 virtual targets that are presented in the front of the participant and within the workspace where most natural arm movements are performed. During training the participant will reach a total of 400 times. For standard practice, participants will be able to see a cursor that represents the position of the hand at all times and try to make straight reaches to the targets. This type of feedback provided specific information about the location of the hand.

干预措施: Reach training with visual feedback (Behavioral)

结局指标

主要结局

Hand path distance during natural reaching to the trained target locations.

时间窗: Assessed every study visit week 1 to week 12

Hand path distance is the percent above an ideal (straight reach) averaged over reaches to all 4 targets. To collect this measure, investigators will use motion capture equipment to record the positions of active markers that subjects will wear on their shoulder, elbow, wrist, and finger.

次要结局

  • ARAT ( Action Research Arm Test)(Assessed week 1 before the first training session, and week 12)
  • ICARS (International Cooperative Ataxia Rating Scale)(Assessed week 1 before the first training session, and week 12)

研究者

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

Amy J. Bastian, Ph.D.

Professor of Neuroscience

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

研究点 (2)

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