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临床试验/NCT04000256
NCT04000256进行中(未招募)不适用

Understanding Experiences of People With Spinal Cord Injury Undergoing Activity-based Rehabilitation

Thomas Jefferson University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
20
试验地点
2
主要终点
10-item questionnaire

研究概览

简要总结

Incomplete cervical spinal cord injury (SCI) makes up half of all the newly admitted patients. For these individuals, the use of their upper limbs is critical for managing daily activities and self-care and impacts their quality of life. For home-based monitored rehabilitation, also called telerehabilitation, there are various rehabilitation equipment that are used. No studies have systematically gathered information regarding the perceptions of individuals with SCI regarding these equipment, training, and feasibility within the home. Further, their perceptions of the usability of high vs low end equipment is also not explored. In this study, investigators plan to gather survey and interview data from individuals with SCI regarding their experience with using rehabilitation equipment that uses games, muscle stimulation, and object manipulation. This study will inform the development of a tele-rehabilitation intervention in the future.

详细描述

Incomplete cervical spinal cord injury (SCI) makes up half of all the newly admitted patients. The overall prognosis for walking is better than the upper limb recovery in incomplete tetraplegia. Upper limb deficits result in difficulty in managing daily activities and self-care and impacts quality of life. Rehabilitation of the upper limb involves high intensity repetitive activities that are directed to a specific task. The demands of these programs can be up to 5 hours of therapy, 5 days a week for 12 weeks. Home-based therapies augmented by tele-rehabilitation presents a more realistic alternative to clinic-based application of these programs due to transportation and time commitment. However, engaging and motivating therapy options are needed for home to enhance client outcomes and improve compliance. Some of the latest equipment provides this capability and engages the patient using games for training. However, high equipment cost limits its widespread use.

In this study, we will engage individuals with cervical SCI in a 4-week (8 visit) evaluation of a variety of training protocols to gather information on their perceptions regarding motivation, engagement, and challenge it offers; its ability to address limitations they experience; and its feasibility within the home.

The long-term goal of this National Institute of Disability Independent Living and Rehabilitation (NIDILRR) funded Spinal Cord Injury Model System (SCIMS) project is to develop an engaging and evidence-informed intervention for home-based upper limb activity-based rehabilitation in individuals with spinal cord injury (SCI). A review of literature was recently conducted by the research team to get a scope of the evidence related to current activity-based therapies and the equipment used to deliver these programs. There is insufficient information about the value of high-end equipment involving games relative to lower cost alternatives, or the perceptions of clients regarding the use of various technologies related to motivation, engagement, appropriate level of difficulty and feasibility within the home. This lab-based study aims to understand the experiences related to rehabilitation training and high and low end equipment for upper limb activity-based rehabilitation in individuals with spinal cord injury.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Motor incomplete cervical SCI, neurologic levels C1-C7
  • Atleast one arm with active shoulder flexion (reach with gravity eliminated) and atleast one grasp pattern/able to move fingers
  • At least 6 months post injury
  • At least one arm with greater than 50% normal passive range of motion in all upper limb joints, excluding the interphalangeal joints of the fingers
  • Medically stable with no contraindications to the activities or to sitting
  • 18 years of age or older

排除标准

  • Uncontrolled pain in the upper limbs
  • Upper extremity amputations
  • Unable to commit to at least 3 visits
  • Surgical procedures (e.g., tendon transfers) or orthopedic trauma (e.g., fracture) within the past 3 months
  • Other neurological conditions
  • Mechanical Ventilation

结局指标

主要结局

10-item questionnaire

时间窗: Week 4

Quantitative feedback using a 10-question survey regarding experiences with the rehabilitation training and equipment for feasibility, motivation, engagement and difficulty.

次要结局

  • Qualitative interview(Week 2)
  • 10-item questionnaire(Week 2)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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