Use of Low Cost Prostheses to Improve Upper Extremity Function in Children With Cerebral Palsy
2020年10月29日 更新者：NYU Langone Health
The purpose of the study is to assess the effectiveness of an upper extremity prosthesis in improving the upper extremity function of children with cerebral palsy who have limited use of their hands.
Twelve children, aged 4-17 years, who have cerebral palsy and limitations in their ability to use their hands, will be enrolled.
All participants will be fitted with a 3D printed arm/hand prosthesis and receive 8 occupational therapy sessions.
Each subject will be evaluated pre-treatment, post-occupational therapy sessions and at 6 months follow-up.
The evaluation will include assessment of (1)passive and active arm/hand movement and (2)functional hand skills using several standardized tests.
The results from the pre-treatment and the two post-treatment evaluations will be compared.
研究概览
研究类型
介入性
注册 (实际的)
6
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
New York
-
New York、New York、美国、10016
- New York University School of Medicine
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
4年 至 17年 (孩子)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Diagnosis: cerebral palsy
- 4-17 years old
- MACS levels III - V
- Active movement of wrist or elbow
Exclusion Criteria:
- MACS levels I, II
- Botox or orthopedic surgery in past 6 months
- Severe contractures
- Lack of voluntary arm motion
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Prosthesis
|
Each occupational therapy treatment will be a one-hour standardized session that will include the following: stretching/strengthening (approximately 20 minutes), bi-manual training (approximately 20 minutes), and activities of daily living (approximately 20 minutes).
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of Participants With Clinically Significant Increase in Assisting Hand Assessment (AHA) Score
大体时间：Week 8
|
The Assisting Hand Assessment (AHA) is a 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.
An assessment is performed by observing the child's spontaneous handling of toys in a relaxed and playful session.
Scores based on 22-items on a 4-point rating scale evaluating quality of the performance (1=does not do, 4=effective).
The range of sum scores is 22-88 points.
A clinical significant increase in score indicates an increase in quality of performance.
|
Week 8
|
|
Number of Participants With Increase in Pediatric Motor Ability Log (PMAL) Scores Post-Treatment
大体时间：8 weeks
|
The PMAL is a structured interview in which the caregiver reports "How Often" (amount) and "How Well" (quality of movement) the child uses their involved upper limb when completing 22 activities of daily living.
Scores range from 0-10; the higher the score, the better the quality of movement.
An increase in PMAL score indicates a higher amount of upper extremity use and better quality of movement.
|
8 weeks
|
|
Number of Participants With Increase in Melbourne Assessment 2 (MA2) Scores
大体时间：Week 8
|
The Melbourne Assessment 2 (MA2) is a valid and reliable criterion-referenced test for evaluating four elements of upper limb movement quality in children with a neurological impairment aged 2.5 to 15 years: (i) Range of motion, (ii) Accuracy of reach and placement, (iii) Dexterity of grasp, release and manipulation and (iv) Fluency of movement.
An increase in score indicates an increase in upper limb movement quality.
|
Week 8
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of Participants With Increase in Pediatric Quality of Life Inventory Subtest Scores Post-Treatment
大体时间：8 weeks
|
The PedsQL is a brief, standardized, generic assessment instrument that systematically assesses patients' and parents' perceptions of HRQOL in pediatric patients with chronic health conditions using pediatric cancer as an exemplary model.
7 sub-tests will be reported on.
Higher scores indicate better HRQOL (Health-Related Quality of Life), an increase in score indicates an increase in HRQOL.
|
8 weeks
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Alice Chu, MD、NYU Langone Health
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年4月1日
初级完成 (实际的)
2020年1月13日
研究完成 (实际的)
2020年1月13日
研究注册日期
首次提交
2017年4月17日
首先提交符合 QC 标准的
2017年4月17日
首次发布 (实际的)
2017年4月20日
研究记录更新
最后更新发布 (实际的)
2020年11月20日
上次提交的符合 QC 标准的更新
2020年10月29日
最后验证
2020年10月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Occupational Therapy Treatment的临床试验
-
Institute of Liver and Biliary Sciences, India招聘中
-
University of Applied Sciences and Arts of Southern...Vrije Universiteit Brussel; Universiteit Antwerpen; THIM - die internationale Hochschule für Physiotherapie完全的
-
Abbott Medical Devices完全的