跳至主要内容
临床试验/NCT02875054
NCT02875054已完成不适用

Camp High 5 2016: Evaluation of the Effect on Upper Limb Function

NYU Langone Health1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2016年6月1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
10
试验地点
1
主要终点
Pediatric Motor Activity Log

研究概览

简要总结

Randomized control trial to evaluate uni-manual and bimanual upper limb function as well as compare outcomes of varied cast wear in children with hemiplegic cerebral palsy (CP) following a hybrid camp model of modified constraint induced movement therapy (mCIMT) and hand-arm bimanual intensive training (HABIT).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
2 Years 至 12 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Participants will range from 2 years to 11 years 11 months of age at time of enrollment. Children under 5 years of age will attend a morning session and children 6 years and older will attend an -Diagnosis: hemiplegia resulting from a neurological Injury
  • •Manual Ability Classification System or Mini Manual Ability Classification System classification I-III

排除标准

  • •Botox injection within past 6 months or planned for within 6 months post camp
  • •Inability to follow commands
  • •Family unable to commit to daily sessions for 4 weeks
  • •Unable to tolerate assigned casting protocol (3-24 hours) daily for 4 weeks

研究组 & 干预措施

Continued Casting

Active Comparator

Participants with 24 hour cast wear (continued casting) for the entire duration of the constraint portion of camp (2 initial weeks).

干预措施: Constraint induced movement therapy (CIMT) (Behavioral)

Continued Casting

Active Comparator

Participants with 24 hour cast wear (continued casting) for the entire duration of the constraint portion of camp (2 initial weeks).

干预措施: Hand-arm bimanual intensive training (HABIT) (Behavioral)

Intermittent Casting

Active Comparator

Participants who wear a univalve cast for 3 hours of constraint camp with home exercise program of 2 hours cast wear on the weekends (intermittent casting).

干预措施: Constraint induced movement therapy (CIMT) (Behavioral)

Intermittent Casting

Active Comparator

Participants who wear a univalve cast for 3 hours of constraint camp with home exercise program of 2 hours cast wear on the weekends (intermittent casting).

干预措施: Hand-arm bimanual intensive training (HABIT) (Behavioral)

结局指标

主要结局

Pediatric Motor Activity Log

时间窗: 6 Months

parent questionnaire to determine how well and how often the family perceives the child Spontaneously uses their affected Upper Extremity throughout the day at home. This assessment is scored by adding up the parental score and getting an average score.

Assisting Hand Assessment

时间窗: 6 Months

Test of hand function in children with difficulties using one of their hands. The AHA measures how effectively the affected hand and arm is used in bimanual performance.

Melbourne-2

时间窗: 6 Months

Test of unilateral upper limb function is a validated and reliable tool for evaluating quality of upper limb movement in children with neurological conditions aged 2.5 to 15 years.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验