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临床试验/NCT02700178
NCT02700178已完成不适用

Development of a Biofeedback Intervention to Reduce the Risk of Upper Extremity Overuse Injury Following Paraplegia and Tetraplegia

Mayo Clinic2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2016年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Mayo Clinic
入组人数
10
试验地点
2
主要终点
change in risk of shoulder impingement

研究概览

简要总结

This study will evaluate movement of the arm and forces put through the hand during activities performed in a manual wheelchair. The goal of this study is to identify what motions and forces are most likely to lead to the development of pain or pathology and determine the feasibility of strategies to modify movements and decrease risk.

详细描述

Participants in the study will be asked to participate in the following during the first (1st) session:

  1. Physical exam assessing joint motion

  2. Questionnaires asking about shoulder pain

  3. All or a subset of the following activities:

  4. Level wheelchair propulsion for up to 10 minutes

  5. Ramp wheelchair propulsion

  6. Lifting the wheelchair, including into a car (simulated car in therapy area)

  7. Transferring in/out of the wheelchair

  8. Overhead tasks (such as lifting an object off a shelf)

  9. Reaching

During the next session(s), participants will be asked to participate in all or a subset of the activities listed above (3a-3f) and will also be guided through a biofeedback intervention. The intervention will consist of visual and/or auditory cues to guide movement while performing the tasks. The visual biofeedback will consist of line or shape targets on a screen that are the participant's goal to achieve with their movements. The auditory cues will be a tone or multiple tones to alert the participant when to move and/or when targets have been achieved. During the biofeedback session the study staff may also provide verbal cues and feedback.

The investigators may review the medical records of the participants to obtain information about their spinal cord injury, wheelchair and any injury to their muscles, ligaments, bones or nerves.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18-60 at time of enrollment
  • Spinal cord injury or disease leading to paraplegia or tetraplegia
  • Uses a manual wheelchair as primary mode of mobility
  • Independently mobile enough to participate in the study
  • Active shoulder and wrist range of motion within limits needed for the tasks performed during the study

排除标准

  • Surgery or significant injury to the shoulder(s) or wrist(s) of interest (such as dislocation, fracture or full rotator cuff tear) in which return to pre-injury functional status was NOT attained
  • Peripheral nerve impairment of the upper extremity being tested
  • Evidence of significant denervation of multiple scapular muscles
  • Shoulder or wrist instability on the upper extremity to be tested
  • Allergy to medical grade adhesive tape (used to secure sensors to skin)

结局指标

主要结局

change in risk of shoulder impingement

时间窗: approximately 6 months

Risk of shoulder impingement, based on the relative orientation of the humerus and scapula during activities of daily living, will be evaluated at the first appointment and following the biofeedback intervention. The change in this outcome will be evaluated for significance.

次要结局

  • change in wrist posture(approximately 6 months)

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kristin Zhao, PhD

Director, Assistive and Restorative Technology Laboratory

Mayo Clinic

研究点 (2)

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