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临床试验/NCT03766711
NCT03766711已完成不适用

FEATHERS 2.0: Functional Engagement in Assistive Therapy Through Exercise Robotics v2.0

University of British Columbia4 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2018年1月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
5
试验地点
4
主要终点
Change in Error in Forward Reaching Symmetry

研究概览

简要总结

This project is a continuing study from the FEATHERS project (NCT02290353) which focuses on developing novel home therapy program for persons with hemiparesis. This study will focus on examining motor behaviour and adaptation in neurodevelopmental hemiparesis (cerebral palsy, acquired brain injury (ABI)). New algorithms for motion control involved in encouraging active movement are developed and will be tested, but the study has the same therapeutic goal and focus as the original FEATHERS project of creating an engaging at-home bimanual upper limb training program. By incorporating existing gaming technology, we hope to discover novel ways to adapt commercial motion tracking controllers and visual feedback into engaging rehabilitative learning tools. This study will focus on a basic science aspect of human bimanual movements that can be incorporated into future applications of the full FEATHERS project devices. We believe that together these approaches will yield interventions that significantly improve functional ability and lead to improved quality of life.

详细描述

(Main Phase Only - Data Collected with Clinical Population)

The FEATHERS project at the RREACH Lab at The University of British Columbia focuses on developing and evaluating novel physical exercise technologies for kids with motor disabilities. The study team would like to study how immersive virtual reality (VR) technology can be used to benefit upper limb rehabilitation for persons with hemiplegia. The purpose of the experiment is to see how the use of error augmentation (i.e. adding visual or game element feedback to accentuate deviation from the desired exercise motion) might encourage persons with hemiplegia to engage their affected side more effectively by comparing the symmetry between the stronger and weaker limbs. It is also hypothesized that the immersive environment of VR and the ability to provide 1:1 direct visual feedback will increase active engagement to rehabilitative exercises in these populations. The study will address the question of whether error augmentation aids in the rehabilitation of the affected upper limb movement quality in hemiparesis when practicing bilateral reaching tasks. Specifically, can visual amplification of paretic asymmetry in an immersive VR environment improve movement quality in the affected side?

Adolescents and young adults with hemiplegia (i.e. due to ABI, CP, etc.) and their adjoining therapists will be recruited for from the community. We will conduct testing in a single-session setup at the participant chosen location with an easily transportable system including a standard 2-3 sensor Oculus system hardware setup and software developed by the research team. Sessions conducted outside the research lab rooms will require a minimum of a 2m x 1.5m space for calibration. The participants will test all augmentation factors in a randomized order and the sessions are expected to take between 90-120 minutes. A short post-session usability survey will be administered and sample population demographic data will be recorded including age, gender, and handedness. Manual Ability Classification System (MACS) and Bimanual Fine Motor Function (BFMF) scores will be recorded or assessed to classify the upper limb motor ability of the sample set.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Single (Participant)

盲法说明

Participant intervention arm will be randomized and they will not be told which whether the treatment is being applied in the current set. However, they will be instructed of the task goal at the beginning of the session and will be told that we will be modifying visual feedback to help improve reaching symmetry in some manner.

入排标准

年龄范围
13 Years 至 21 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • i. Upper limb orthopedic surgery in the past six months
  • ii. Known susceptibility to cybersickness

结局指标

主要结局

Change in Error in Forward Reaching Symmetry

时间窗: Recorded per reach, throughout the session (about 2 hours)

Compared between each condition (in cm, % change from baseline)

次要结局

  • Distance traveled of each arm from head(Recorded per reach, throughout the session (about 2 hours))
  • Time to complete task(Recorded per reach, throughout the session (about 2 hours))
  • Movement Smoothness(Recorded per arm, per reach, throughout the session (about 2 hours))
  • Change in Error in Forward Reaching Symmetry Over Time(Recorded per reach, throughout the session (about 2 hours))
  • Compensation Techniques Causing Joint Asymmetry(Recorded throughout the session (about 2 hours))
  • Trunk Compensation(Recorded throughout the session (about 2 hours))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hendrik F. Machiel Van der Loos

Associate Professor, Dept. Mechanical Engineering

University of British Columbia

研究点 (4)

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