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临床试验/NCT01158781
NCT01158781已完成不适用

Restoration of Life Role Participation Through Integrated Cognitive and Motor Training for Individuals With TBI

Malcom Randall VA Medical Center2 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2012年5月最近更新:
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
5
试验地点
2
主要终点
Berg Balance

研究概览

简要总结

The purpose of this study is to restore life role participation for those with TBI by customizing, applying, and testing integrated cognitive and motor training protocols that were successful in populations with impairments similar to TBI. The treatment protocols are based on principles of brain plasticity and re-learning, required to restore cognitive and motor function. The intervention targets an array of impairments that are obstacles to life role participation. These include cognitive attention and executive control; motor control for upper limb function; balance and gait; and cognitive executive control of simultaneous cognitive and motor tasks required by everyday tasks. The intervention utilizes training specificity, framing the intervention within functional task and life role activity component practice.

详细描述

The investigators will use an assessment and treatment decision schema that has been successful in restoration of life role participation for stroke survivors and a comparable schema used for cognitive training for TBI patients. The subject assessment and decision schema will be used to identify for each subject, the optimal array of impairment interventions. The proposed treatment will optimize outcome by customizing the intervention and use of technologies, while ensuring the application of the array of impairment interventions required to produce restoration of function and life role participation. The investigators will target an array of impairments preventing participation in life role activities, which will include dyscoordination and weakness of upper limb, impaired balance, gait deficits, and impaired attention and executive function. In treatment, the investigators will use a dual-task paradigm combining motor and cognitive training, with treatment extending to the every day environment. Treatment will be up to 5 times/wk, 5hrs/day for 12 weeks.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
Single (Outcomes Assessor)

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

  • Medically Stable
  • Age > 18 years
  • Ability to walk at least with the minimum assistance of one person or an assistive device
  • At least 6 months post injury
  • Ability to follow 2 stage commands

排除标准

  • pacemaker
  • Acute medical conditions
  • potential subjects will undergo a screening evaluation to determine eligibility for study entry

研究组 & 干预措施

gait, balance, arm function, cognition

Experimental

12 weeks of training for balance, gait, upper limb function, and cognition

干预措施: Experimental: gait, balance, arm function, cognition (Behavioral)

结局指标

主要结局

Berg Balance

时间窗: week 12

Balance function

次要结局

未报告次要终点

研究者

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

Janis Daly

Director, Brain Rehabilitation Research Center

North Florida/South Georgia Veterans Health System

研究点 (2)

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