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临床试验 NCT06693388 针对脑瘫 (CP)，脑瘫目前招募中。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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WBV and Serial Casting for Children With Cerebral Palsy 45 运动
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临床试验NCT06693388是一项针对脑瘫 (CP)，脑瘫的干预性研究试验，目前试验状态为招募中。试验始于2024年11月11日，计划招募45名患者。该研究由Ben Reader主导，预计于2026年12月31日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2026年3月25日。
简要概括
Children with cerebral palsy have increased muscle tone which often results in decreased active and passive movement at the ankle. While many management strategies exist (including passive stretching, WBV, serial casting, Botox, and surgical tendon lengthening), the utilization of WBV in combination with active exercises and serial casting has not been previously explored. Serial casting is the repeated application o...显示更多
官方标题
Whole-body Vibration for Children With Cerebral Palsy Undergoing Serial Casting
疾病
脑瘫 (CP)脑瘫其他研究标识符
- STUDY00004078
NCT编号
实际开始日期
2024-11-11
最近更新发布
2026-03-25
预计完成日期
2026-12-31
计划入组人数
45
研究类型
干预性研究
试验分期 (阶段)
不适用
试验状态
招募中
关键词
Serial Casting
Whole body Vibration
Cerebral Palsy
Pediatrics
Whole body Vibration
Cerebral Palsy
Pediatrics
主要目的
卫生服务研究
分配方式
随机
干预模型
平行
盲法
单盲
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
阳性对照Serial Casting Only | 连续石膏固定 Serial Casting as provided by standard of care |
阳性对照Serial Casting + Exercise | 锻炼 2 minutes each exercise with 30 sec break - 4 exercises prior to serial casting 连续石膏固定 Serial Casting as provided by standard of care |
阳性对照Serial Casting + Exercise + WBV | 锻炼 2 minutes each exercise with 30 sec break - 4 exercises prior to serial casting Whole-Body Vibration WBV prior to serial casting 连续石膏固定 Serial Casting as provided by standard of care |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Ankle Dorsiflexion Range of Motion (Goniometer) | Measured with Goniometer in degrees. Knee flexed and knee extended. | Longitudinal through study completion, an average of 6 weeks but upto 12 weeks |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Pain (Visual Analogue Scale/Wong-Baker Faces) | Wong-Baker Faces will be used for those unable to provide a visual analogue scale score. Visual Analogue Scale = 0 (no pain) - 10 (worst pain). Wong-Baker Faces = ordinal level categories of pain. Categories = 0 no hurt, 2 hurts little bit, 4 hurts little more, 6 hurts even more, 8 hurst whole lot, 10 hurts worst. On both scales, higher number will be worst outcomes. | Longitudinal through study completion, an average of 6 weeks but upto 12 weeks |
Length of Casting Episode (Weeks) | Measured in weeks from the date of first serial cast application to date of last cast applied. This will be extracted from the electronic health record. | Longitudinal through study completion, an average of 6 weeks but upto 12 weeks |
参与助手
资格标准
适龄参与研究
儿童
最低年龄要求
3 Years
适龄性别
全部
- Ages 3-17 and 32 weeks exclusive years;
- Diagnosis of cerebral palsy;
- GMFCS levels I-III;
- Stands with upper extremity support or less support;
- Active referral from a prescribing provider for serial casting with ankle DF of <10 degrees;
- Willing to pursue care at \[primary site\] outpatient physical therapy clinic for the duration of the study;
- Subjects/families must be able to communicate in the English language without the need for interpreter.
- History of selective dorsal rhizotomy;
- previous Achilles tendon lengthening or other orthopedic interventions to the lower extremities in 1 year prior to enrollment;
- skin, circulation, vascular conditions;
- Previous history of cancer;
- Reduced ankle/foot sensation;
- Allergies to casting materials.
Ben Reader研究责任方
Ben Reader, 申办者-研究者, Research Scientist, Nationwide Children's Hospital
研究中心联系人
联系人: Ben Reader, DPT, 614-722-8374, [email protected]
1 位于 1 个国家/地区的研究中心
Ohio
Nationwide Children's Hospital, Columbus, Ohio, 43228, United States
Ben Reader, DPT, 联系人, 614-722-8374, [email protected]
招募中