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临床试验/NCT03985761
NCT03985761已完成不适用

Utilizing Gaming Mechanics to Optimize Telerehabilitation Adherence in Persons With Stroke

Rutgers, The State University of New Jersey2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2019年9月8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
32
试验地点
2
主要终点
Total Intervention Time

研究概览

简要总结

This trial studies the impact of motivational strategies designed by the gaming industry on adherence to a home tele-rehabilitation program designed to improve hand function in persons with stroke. A growing literature suggests that the extended practice of challenging hand tasks can produce measurable changes in hand function in persons with stroke. Current health care delivery systems do not support this volume of directly supervised rehabilitation, making it necessary for patients to perform a substantial amount of activity at home, unsupervised. Unfortunately, adherence to unsupervised home exercise regimens is quite poor in this population. The investigator's goal is to assess the impact of several well-established game design strategies: 1) Scaffolded increases in game difficulty 2) In-game rewards 3) Quests with enhanced narrative. The investigator's will utilize these enhancements to study their impact on motivation to perform a tele-rehabilitation- based home exercise program, adherence to the program and changes in hand function. The proposed study will utilize a system of novel rehabilitation technologies designed to facilitate home exercise performance. Subjects will perform 3 simulated rehabilitation activities supported by a passive exoskeleton, an infrared camera and software that will allow subjects to exercise at home. The investigator's will investigate: 1) Differences in measures of motivation elicited by motivationally enhanced simulations and un-enhanced control versions.2) The impact of motivational enhancements on actual adherence to a tele-rehabilitation program in persons with stroke and 3) The impact of motivational enhancement on improvements in hand function achieved by these subjects. This proposal will address a critical gap in modern rehabilitation - adherence to autonomous rehabilitation programs. Patient participation in unsupervised rehabilitation is one of the assumptions underpinning our health care system. This said, no data collected to date supports that adherence is acceptable. The technology and methodology in this proposal are an important step towards leveraging extensive research and development done by the computer gaming industry into improved rehabilitation practice.

详细描述

  1. Purpose/Specific Aims The overarching aim of this study is to provide a mechanism for patients to engage in progressive motor practice for a meaningful time period. The investigator's aim to improve on the positive outcomes demonstrated in patients in the chronic phase and the pilot work being done on patients in the acute in-patient phase post stroke to determine whether functional recovery can be further improved using a home based system.

Aim 1: Evaluate compliance with Home-Telerehabilitation simulated hand/arm gaming activities and two computer game groups, one with motivation enhanced: Home Training Motivation Enhanced (HTme) simulations and one with non-enhanced simulations: Home Training Unenhanced (HTu) versions. Hypothesis: Participants in the HTme group will show significant compliance as compared to the control group (HTu).

Aim 2: Evaluate the effectiveness of motivation enhanced HTme home-based virtually simulated hand/arm gaming activities for individuals with stroke as compared to a program unenhanced HTu versions of the same simulations. Hypothesis: Participants completing HTme training will exhibit significantly improved clinical, kinematic and neurophysiological outcomes as compared to the control group (HTu).

Aim 3: Evaluate the impact of the motivation enhancements designed into computer games to provide a more enjoyable training experience. Hypothesis: Enjoyment of the games will be a more valid predictor of compliance than personal factors. 2. Background and Significance Studies have shown that sustained hand rehabilitation training is important for continuous improvement and maintenance of function following a stroke. It is unimaginably difficult to pursue education, employment and community participation without being able to independently use one's hands. The primary goal of this study is to test an exciting new technology that can be easily used in the home for long-term hand and upper extremity training. Recovery of hand function post brain injury is particularly recalcitrant to currently available interventions. To date, the best efforts of groups studying traditionally presented as well as technology-based therapeutic interventions for the hemiplegic hand and arm have produced measurable changes in motor function and motor control but fall far short of major reductions in disability.

If the amount of therapy is critical to rehabilitation, our current institutional limitations undermine the probabilities for successful outcomes. After discharge from the inpatient stay, access to rehabilitation therapy can be difficult for some patients. This is due in part to inadequate insurance, lack of transportation, and the patient's dependence on their caregiver. Having access to long-term rehabilitation training anywhere and at any time is necessary for sub-acute and chronic patients to continuously improve their functional abilities. 3. Research Design and Methods This study will be a single blind randomized controlled trial. Subjects will be blinded to the purpose of the study. All outcome measures will be performed by a therapist blinded to group assignment. A controlled trial will be utilized to determine the additive effect of presenting rehabilitation activities in a virtual environment as compared to standard upper extremity exercise. The investigators will randomize subjects to treatment and control groups using a computerized random number generator.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • unilateral stroke
  • score of 22 or greater on the Montreal Cognitive Assesment
  • Score of 1 or better on extinction and inattention portion of NIH Stroke Scale
  • Fugl-Meyer (FM) between 36-58/66 (
  • Score of 1 or better on language portion of NIHSS
  • intact cutaneous sensation (ability to detect <4.17 Newton stimulation using Semmes-Weinstein nylon filaments)

排除标准

  • Orthopedic issues that would limit the ability to perform regular upper extremity activity

结局指标

主要结局

Total Intervention Time

时间窗: Day one through day ninety of intervention period

Total intervention time performed by patient during study period

Upper Extremity Fugl Meyer Assessment

时间窗: 12 weeks

Difference between post test and pretest Upper Extremity Fugl Meyer Assessment Scores. Scores between 0 and 66. The Upper Extremity Fugl-Meyer Assessment is a clinical scale that is a composite measure of 33 performance based items, scored 0,1 or 2. Total score reflects the sum of the 33 individual item scores. Higher scores reflect better performance.

Intrinsic Motivation Inventory

时间窗: 12 weeks

Difference between score measured three months after baseline and the score measured at baseline on the Intrinsic Motivation Inventory. Scores range = 0-84. Higher score equals higher levels of intrinsic motivation.

次要结局

  • Average Intervention Time Per Intervention Day(Day one through day ninety of intervention period)
  • Action Research Arm Test(12 weeks.)
  • Box and Blocks Test(12 weeks)

研究者

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

Gerard G Fluet DPT, PhD

Associate Professor

Rutgers, The State University of New Jersey

研究点 (2)

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