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临床试验/NCT03538795
NCT03538795终止不适用

Priming the Brain for Rehabilitation: Brain Stimulation Followed by Constraint-Induced Movement Therapy in Adults With Severe Arm Paresis After Stroke

University of Alabama at Birmingham2 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2018年6月11日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
3
试验地点
2
主要终点
Motor Activity Log (MAL)

研究概览

简要总结

This pilot study will examine a combination therapy for adults with chronic, severe motor impairment of an arm after stroke. The intervention will combine brain stimulation with physical rehabilitation of the arm on the side of the body more-affected by stroke.

详细描述

The overarching goal of this program of research is to develop a therapy that produces meaningful and persistent improvements in function of the more-affected arm in stroke survivors with severe, chronic hemiparesis. No treatment with an established evidence base is available now for this large group, who have barely perceptible voluntary movement of the more-affected fingers and wrist. The lab of E. Taub and G. Uswatte has developed an expanded version of Constraint-Induced Movement therapy (CIMT) for this population that has evidence of efficacy for improving use in daily life of the more-affected arm from a case series and small randomized controlled trial (RCT). The original version of CIMT is a form of physical rehabilitation that has evidence of efficacy from multiple RCTs for improving use in daily life of the more-affected arm in adults with mild to moderate hemiparesis after stroke. CIMT has also been shown to produce neuroplastic changes in both grey and white matter structures. Expanded CIMT (eCIMT) combines CIMT with neurodevelopmental techniques (NDT) for managing tone. Studies from by J. Szaflarski and by others suggest that priming CNS tissue for training by electrically stimulating the brain regions that control the target function with excitatory intermittent theta burst stimulation (iTBS) augments the benefits of neurorehabilitation. This pilot study will evaluate the feasibility of combining eCIMT with brain stimulation by iTBS and, on a preliminary basis, will evaluate whether this combination therapy boosts treatment outcomes relative to eCIMT alone.

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
None

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

  • > 12 months after stroke onset
  • severe hemiparesis of more-affected arm

排除标准

  • substantial use of the more-affected arm in daily life
  • frailty or insufficient stamina to carry out the requirements of the therapy
  • other neurological or musculoskeletal problems, including pain, affecting the more-affected arm
  • severe cognitive deficits

结局指标

主要结局

Motor Activity Log (MAL)

时间窗: Change from Day 0 to Day 42

Structured interview that assesses use of the more-affected arm in daily life. Scale range is 0 (no use of the more-affected arm) to 5 (use that is as good before stroke). Higher scores are better. Score reported is change from Day 0 to Day 42.

次要结局

  • Canadian Occupational Performance Measure (COPM)(Change from Day 0 to Day 42)
  • Wolf Motor Function Test (WMFT)(Change from Day 0 to Day 42)

研究者

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

Gitendra Uswatte

Professor of Psychology and Physical Therapy

University of Alabama at Birmingham

研究点 (2)

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