Functional Electrical Stimulation Therapy for Children With Upper Limb Weakness Post Stroke: Evaluation of the Mynd Move Technology
试验速览
- 阶段
- 不适用
- 入组人数
- 3
- 主要终点
- Wong-Baker Faces Pain Scale
研究概览
简要总结
A new technology system called MyndMove has been developed by MyndTec Inc. (Missisauga Canada) to administer FES. The purpose of this technology is to improve voluntary upper limb (hand and arm) function (i.e. reaching and grasping) for patients with hemiparesis as a results of stroke or spinal cord injury (7). It is a non-invasive application that delivers electrical stimulation to the affected limb transcutaneously. MyndMove has been licensed by Health Canada and is indicated as a functional electrical stimulator for improvement of arm and hand function and active range of motion in patients with hemiplegia due to stroke or upper limb paralysis due to C3-C7 spinal cord injury. In a randomized controlled trial looking at adults with acute stroke and limited or complete immobility of the arm, FES and intensive therapy was shown to have significant improvement of hand function compared to the control group that was exposed to intensive therapy only (8). Limited research using MyndMove to administer FES has been conducted for pediatric populations, however there is significant potential for FES and intensive therapy to improve hand function for children with upper extremity hemiparesis using MyndMove technology. Before the efficacy of MyndMove therapy can be evaluated in children age 3 to 6, the tolerability of the system must first be evaluated and proven for this age group.
详细描述
Research Questions and Objectives:
The overall goal of this study is to determine if therapy administered using MyndMove can be tolerated by children age 3 to 6 with upper extremity hemiparesis and produce effective response without injury or pain.
The objectives of this study are:
- To evaluate the tolerability of MyndMove technology to safely provide Functional Electrical Stimulation (FES) transdermally as therapy in young children
From these findings the researchers aim to: 2. To establish clinical recommendations for the next step of this study, which will evaluate the efficacy of MyndMove therapy with this population using a pre-post case series model .
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •i) Ischaemic or Haemorrhagic stroke with hemiparesis of the upper extremity; ii) Willing to attend therapy; and iii) Communicate effectively in English.
排除标准
- •i) Global aphasia; ii) Upper extremity condition that limits the function of the hand and arm before the stroke; iii) Active seizure disorder within 5 years; iv) Implanted pacemaker, vagal nerve stimulator, AICD, baclofen pump, or similar implanted metallic or electronic device; v) Unhealed fracture or wound in the affected arm; vi) BOTOX injection into the affected arm or hand within 6 months; vii) Currently enrolled in another study of upper limb therapy or new investigational drugs/biologics within 6 months; viii) Swollen, infected or inflamed areas or skin eruptions on the affected arm including evidence of phlebitis or venous incompetence in the arm; ix) Known cardiac dysrhythmia; x) cancerous or suspected cancerous lesions present on the affected arm and xi) Cognitive impairment sufficient enough to impede in the following of directions and understanding of the nature of the therapy, xii) Unwilling/unable to assent to study.
结局指标
主要结局
Wong-Baker Faces Pain Scale
时间窗: Administered at Appointment 2 (Day 7 of study)
This is a pain scale.The scale shows a series of faces ranging from a happy face at 0, "No hurt" to a crying face at 10 "Hurts worst".
次要结局
- Quality of Upper Extremity Skills Test (QUEST)(Administered at appointment 1 (Day 0 of study))