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临床试验/NCT06452576
NCT06452576已完成不适用

Use of Vibration During Constraint-induced Movement Therapy

Medical University of South Carolina1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2024年7月15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
8
试验地点
1
主要终点
Box and Block Test

研究概览

简要总结

The purpose of this study is to determine whether the hand function will improve more by using low-level vibration during constraint-induced movement therapy (CIMT), compared to CIMT alone without vibration.

详细描述

The low-level vibration has been shown to increase therapy outcome when used as an adjunct to therapy in adults with hemiparesis. Children who participates in the CIMT camp at MUSC will be recruited to take part in the study. Participating children will wear a watch device on their weaker arm during CIMT. The watch will vibrate only for the children who were assigned to the treatment group.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
4 Years 至 9 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Unilateral upper limb motor weakness
  • •Can use the affected upper limb as a gross assist during play and self-care activities
  • •Ambulatory for their age with intact balance and protective reactions in the less involved upper limb.

排除标准

  • •Developmental delays limiting spontaneous use of the affected upper limb
  • •Other health impairment

研究组 & 干预措施

Wear vibrating watch during therapy

Experimental

The watch worn on the affected wrist vibrates during therapy.

干预措施: Vibration (Device)

Wear vibrating watch during therapy

Experimental

The watch worn on the affected wrist vibrates during therapy.

干预措施: constraint-induced movement therapy (Behavioral)

Wear non-vibrating watch during therapy

Placebo Comparator

The watch worn on the affected wrist does not vibrate during therapy.

干预措施: constraint-induced movement therapy (Behavioral)

结局指标

主要结局

Box and Block Test

时间窗: pre-therapy and post-therapy, up to 5 consecutive days

number of blocks moved in a minute

次要结局

未报告次要终点

研究者

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

Na Jin Seo

Professor-Faculty

Medical University of South Carolina

研究点 (1)

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