跳至主要内容
临床试验/NCT02843646
NCT02843646Unknown不适用

Investigating the Use of the WalkAide on a Child's Ability to Ascend/Descend Stairs and Curbs

Blythedale Children's Hospital2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2016年7月最近更新:
适应症

试验速览

阶段
不适用
入组人数
12
试验地点
2
主要终点
Change in the Timed-Up-and-Down-Stairs (TUDS) measure

研究概览

简要总结

The purpose of this study is to investigate the use of the WalkAide, a Neuroprosthetic device, on a child's ability to ascend/descend stairs and curbs. It is hypothesized that with WalkAide use, the improved ankle control achieved, will affect the speed, symmetry, and independence of completing the task.

详细描述

The investigators will examine the use of the WalkAide, a Neuroprosthetic device, on a child's ability to ascend/descend stairs and curbs. It is hypothesized that with WalkAide use, the improved ankle control achieved, will affect the speed, symmetry, and independence of completing the task.

Study subjects will be fitted with the WalkAide by Physical Therapists trained in this procedure. Subjects will build tolerance to the device over a two-week period, and use as able for the next six weeks. The children (participants/subjects) in the study will go through a desensitization process to familiarize them with the electrical stimulation.

The children will begin with no stimulation, wearing the Walkaide to introduce the sensation of the cuff on their leg prior to beginning the stimulation. Once familiar with the feel of the Walkaide, the electrical stimulation will be introduced slowly and gradually. The child's face and verbal responses will be monitored while the stimulation is introduced and turned up to the desired response threshold.

An age and cognitively appropriate pain scale will be available if applicable to the child and situation.

The children will be assured that if they do not want to continue or if they feel uncomfortable, then the electrical stimulation will be turned off immediately. The minimum stimulus intensity is determined in collaboration with each subject. The children are asked to identify when they first begin to feel the stimulus, and the number on the intensity knob is noted. The duration of the stimulus is gradually increased along with the wearing of the Walkaide. Subjects will begin by wearing the prosthesis for 30 minutes. The wearing time will be increased to waking hours of the subject, depending on their age. The electrodes will be placed on the client before the session is to begin, and taken off immediately after WalkAide usage. The skin will be checked before and after WalkAide electrode usage. The skin will be cleaned with an alcohol wipe before the electrodes are applied. It is normal to observe somewhat reddened areas under the electrode placement following usage. However, the redness should disappear within an hour. With signs of irradiation or maintained redness, small pimple like lesions or blisters, the WalkAide usage will be discontinued at that time, and the patient will be brought to the medical staff. The skin will be re-evaluated an hour later following the electrode usage. The Pediatrician for that patient will be immediately notified, and the WalkAide usage discontinued until the problem is resolved.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
8 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Ability to ambulate independently with or without an assistive device and/or lower extremity orthoses.
  • Ability to follow and understand experimental procedures.

排除标准

  • Seizure history interfering with use of functional electrical stimulation as verified by their MD.
  • Inability to be able to complete the assessment tests to gain a baseline score.
  • Skin irritation/skin intact.
  • Uncorrected vision impairments.

结局指标

主要结局

Change in the Timed-Up-and-Down-Stairs (TUDS) measure

时间窗: Day 1 of intervention and up to 5 days after the last day of intervention

Measures the ability of a child to negotiate stairs

Change in the Step-Up-and-Over measure

时间窗: Day 1 of intervention up to 5 days after the last day of intervention

Measures the ability of a child to step up and over a curb

次要结局

  • Pain scale(Each day of therapy, from date of randomization until up to six weeks after date of randomization)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验