跳至主要内容
临床试验/NCT03325946
NCT03325946招募中不适用

The FBRI VTC Neuromotor Research Clinic

Virginia Polytechnic Institute and State University1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2013年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
500
试验地点
1
主要终点
Emerging Behaviors Scale

研究概览

简要总结

The FBRI VTC Neuromotor Research Clinic was established and opened in May of 2013 to provide intensive therapeutic services to individuals with motor impairment secondary to neuromotor disorders. It is direct by Dr. Stephanie DeLuca and based on the principles surrounding ACQUIREc Therapy.

ACQUIREc Therapy is an evidenced-based approach to pediatric constraint-induced movement therapy, which refers to a multi-component form of therapy that is focused on helping children who have asymmetric motor abilities between the two sides of the body. Historically, ACQUIREc Therapy has the unimpaired or less impaired upper extremity constrained (by a cast or a splint) while also receiving active therapy from a specially trained therapist who shapes new skills and functional activities with the child's more impaired upper extremity but who is also a licensed Occupational or Physical Therapist (OT/PT). Therapy dosages are high much higher than tradition OT or PT - often lasting many hours per day, up to 6 hours a day, 5 days a week, for 2-4 weeks.

Investigators have developed further treatments based on the same principles of intensive services combined with behavior shaping for other areas of the body that are also affected by weakness (e.g., the leg and trunk) also, but which usually do not involve constraint. These have been more generally labeled ACQUIRE Therapy.

All forms involve intensive, play-based therapy for children with asymmetric motor impairments of the arms and hands. The primary focus of treatment is to facilitate the acquisition of new motor skills in the child's weaker body parts through high levels of intensive therapy using scientifically-based behavioral guidelines. Therapy is also delivered in naturalistic environments.

ACQUIREc Therapy as a treatment method has been tested in two randomized controlled trials, and a specific manual for its implementation has been developed. Dr. (s) Ramey and DeLuca previously founded a similar clinic, The Pediatric Neuromotor Research Clinic, at the University of Alabama at Birmingham where Dr. DeLuca directed the research clinic for 13 years and oversaw the implementation of the ACQUIREc Therapy treatment protocol in more than 400 cases.

This research will involve analyzing and interpreting the clinical data of children going through clinical procedures at the FBRI VTC Neuromotor Research Clinic. All participation is voluntary and no children will denied services if families choose not to participate.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
3 Months 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Neuromotor Impairment

排除标准

  • fragile health

结局指标

主要结局

Emerging Behaviors Scale

时间窗: up to 12 months

This is a measure of the number of skills a child uses from a set of 31 typical used on a daily basis

次要结局

  • Pediatric Motor Activity Log(Within 1 week prior to treatment and Within 1 week after treatment)
  • Peabody Developmental Motor Scales 2(Within 1 week prior to treatment and Within 1 week after treatment)
  • The Bayley Motor Scales of Infant Development -III(Within 1 week prior to treatment and Within 1 week after treatment)
  • Assisting Hand Assessment(Within 1 week prior to treatment and Within 1 week after treatment)

研究者

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

Stephanie DeLuca

Associate Professor

Virginia Polytechnic Institute and State University

研究点 (1)

Loading locations...

相似试验

The FBRI VTC Neuromotor Research Clinic | 临床试验