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临床试验/NCT05032378
NCT05032378Enrolling By Invitation不适用

Efficacy of a Motion Sensor and Feedback System to Refine Movements of People With Acquired Neurological Injury: A Series of Case Studies

PantherTec1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年12月17日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
20
试验地点
1
主要终点
System Usability Scale (SUS)

研究概览

简要总结

The purpose of these case studies is to determine the efficacy of the Kinesthetic Awareness Training (KAT) device in facilitating the restoration of desired movement patterns when people with acquired central nervous system damage perform functional activities such as walking, transitioning from one position to another, or reaching with the arms.

详细描述

People with acquired neurological disorders often exhibit impaired movement patterns when performing functional activities such as walking, standing up from a seated position, and reaching for objects. Re-establishing normal movement patterns is an essential part of rehabilitation; however, achievement of this typically requires thousands of accurate movement repetitions. Only through this repetition can a person benefit from the inherent neuroplasticity of the nervous system to make restored patterns habitual.

Sensory and/or proprioceptive problems may limit a person's awareness of ways in which abnormal movement patterns differ from desired ones. Because of these problems, provision of external feedback in the form of verbal comments, physical repositioning of the limbs by another person, or other auditory or haptic cues is critical. As a general rule, a person benefits most when provided with precise feedback about the position of body parts when he/she is actively engaged in performing a desired movement. As such, the linking of motion sensors programmed to detect achievement of a target position with immediate auditory (i.e., beeps) and/or haptic (i.e., vibrations) feedback has the potential to be a powerful treatment tool.

The Kinesthetic Awareness Training (KAT) device developed by PantherTec is a wearable, motion capture system that can be programmed to detect and provide immediate auditory and/or haptic feedback when a person moves a specified body part to a target position during performance of a functional sequence of movements. Each time a person replicates the desired movement, the device either begins emitting or ceases emitting beeps and/or vibrations-as specified during programming-to indicate achievement of the correct position. Adjustment of the sensitivity (i.e., margin of error per target value) allows for specification of how close a performed movement must be to the target position to elicit feedback.

PantherTec has made a prototype of the KAT device available to Quality Living, Inc. (QLI) for feasibility testing and exploration of possible applications with people with movement impairments resulting from acquired neurological injury. The purpose of the proposed case studies is to determine the efficacy of the KAT device in facilitating the restoration of desired movement patterns when people with acquired central nervous system damage perform functional activities such as walking, transitioning from one position to another, or reaching with the arms.

研究设计

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

入排标准

年龄范围
16 Years 至 70 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • For participants with movement disorders:
  • Between 16 and 70 years of age
  • Has an acquired movement disorder secondary to neurological injury
  • Understands English sufficiently to follow simple commands
  • Is a current resident of Quality Living, Inc.
  • For professionals:
  • Over 19 years of age
  • A physical therapy or occupational therapy staff member employed by Quality Living, Inc.
  • Has used the KAT device to provide treatment to a participant with a movement disorder

排除标准

  • 未提供

结局指标

主要结局

System Usability Scale (SUS)

时间窗: completion of 8-week treatment provision period

The SUS is a feasibility rating scale for that will be used by professional participants to evaluate the KAT device. It includes 10 items with 5 response options ranging from 1 (strongly disagree) to 5 (strongly agree). Scores for odd-numbered items on the scale are calculated by subtracting 1 from the user's rating; scores for even-numbered items on the scale are calculated by subtracting the user's response from 5. This scales all values from 0 to 4, with four being the most positive response. Summing the converted scores and multiplying by 2.5 yields a score between 0 and 100, with 100 being the most positive score.

Goal Attainment Scaling (GAS) in rehabilitation

时间窗: completion of 8-week treatment period

The GAS uses a 5-point rating scale to describe the extent of a participant's goal achievement. Scores for each attainment goal range from -2 (much worse than expected) to +2 (much better than expected). The composite GAS (the sum of attainment levels x the relative weight for each goal) is transformed into a standardized measure or T score with a mean of 50 and standard deviation of 10.

次要结局

未报告次要终点

研究者

发起方
PantherTec
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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