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临床试验/NCT03478059
NCT03478059已完成不适用

Exploring the Role of Combined Cognitive and Motor Dual-task Assessment and Rehabilitation for Individuals With Residual Symptoms After mTBI

Allina Health System2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2017年10月31日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
2
主要终点
Change in peak velocity turns during Instrumented Stand and Walk Test

研究概览

简要总结

This research aims to develop an intervention that combines mTBI-specific motor and cognitive challenges into a progressive and challenging rehabilitation program. We plan to develop and refine a combined motor and cognitive intervention using healthy athletic young adults (n=12) and people with a positive history of non-resolving mTBI (n=12). We will conduct limited feasibility testing by conducting 6 week training sessions with each subject group. We also plan to identify best measures for determining readiness for duty or full function by incorporating and testing 3 dual-task assessment measures using state-of-the-art wearable sensors to quantify movement.

研究设计

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

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Mild Traumatic Brain Injury

Experimental

60 minute, 3 times per week, 6 week long Cognitive and Motor Dual-task Intervention program. The intervention will consist of 6 stations that target known motor and cognitive impairments after mTBI.

Subjects with mTBI residuals will be gently progressed through exercise stations in an individually tailored fashion.

干预措施: Cognitive and Motor Dual-task Intervention (Behavioral)

Healthy Control

Other

60 minute, 3 times per week, 6 week long Cognitive and Motor Dual-task Intervention program. The intervention will consist of 6 stations that target known motor and cognitive impairments after mTBI.

In addition to providing comparison data, the healthy control, athletic 18-34 year old subjects will be used to identify levels and intensity of progressions of dual-task training stations appropriate for highly trained athletes and military personnel recovering from concussion.

干预措施: Cognitive and Motor Dual-task Intervention (Behavioral)

结局指标

主要结局

Change in peak velocity turns during Instrumented Stand and Walk Test

时间窗: At baseline and after 6 weeks of intervention

Change in peak velocity during 180 degree turns during Instrumented Stand and Walk Test in single task (ST) and dual-task (DT) conditions. DT condition involves grid memorization task.

次要结局

  • Change in peak turning velocity during walking a custom turning course(At baseline and after 6 weeks of intervention)
  • Change in peak turning velocity during running an agility course(At baseline and after 6 weeks of intervention)
  • Change in medial -lateral (coronal plane) sway area during eyes closed, narrowed stance(At baseline and after 6 weeks of intervention)
  • Change in Beck Depression Inventory-II(At baseline and after 6 weeks of intervention)
  • Change in Beck Anxiety Inventory(At baseline and after 6 weeks of intervention)
  • Change in Patient-specific Functional Scale(At baseline and after 6 weeks of intervention)
  • Change in Neurobehavioral Symptom Inventory (NSI)(At baseline and after 6 weeks of intervention)
  • Rey Auditory Verbal Learning Test Score(At baseline)
  • Comprehensive Trails Making Test Score(Baseline)
  • Verbal Fluency Test Score(Baseline)
  • NAB Digits Forward/Digits Backward Test Score(Baseline)
  • Stroop Color-Word Test Score(Baseline)
  • Wide Range Achievement Test-4 Reading Score(Baseline)

研究者

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

Margaret Weightman

Senior Scientific Advisor

Allina Health System

研究点 (2)

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