Whole-body Vibration for Children With Cerebral Palsy Undergoing Serial Casting
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Ankle Dorsiflexion Range of Motion (Goniometer)
研究概览
简要总结
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 of a fiberglass cast (such as that applied to manage stable fractures) on a scheduled (usually weekly basis) to gradually increase the range of motion at a specific joint. It is theorized that combining previously established standard of care practices may result in more rapid clinical change, and hence reduce the need for prolonged intervention; ultimately reducing healthcare costs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Ankle Dorsiflexion Range of Motion (Goniometer)
时间窗: Longitudinal through study completion, an average of 6 weeks but upto 12 weeks
Measured with Goniometer in degrees. Knee flexed and knee extended.
次要结局
- Pain (Visual Analogue Scale/Wong-Baker Faces)(Longitudinal through study completion, an average of 6 weeks but upto 12 weeks)
- Length of Casting Episode (Weeks)(Longitudinal through study completion, an average of 6 weeks but upto 12 weeks)
研究者
Ben Reader
Research Scientist
Nationwide Children's Hospital