用于膝骨关节炎患者基于游戏的家庭治疗的膝关节生物反馈康复接口 (KneeBRIGHT)
基于游戏的家庭治疗膝关节生物反馈康复接口(“KneeBRIGHT”)第二阶段
骨关节炎 (OA) 是美国残疾的主要原因。 由于骨关节炎与下肢肌肉无力有关,通过加强股四头肌力量进行康复治疗是膝骨关节炎患者行之有效的治疗方法,但由于缺乏最佳方案指导以及重复训练过程中缺乏参与,患者对锻炼程序的依从性很低患者觉得乏味乏味的日常活动。
用于基于游戏的家庭治疗的膝关节生物反馈康复接口(“KneeBRIGHT”)系统将肌电图(EMG)生物反馈与视频游戏治疗相结合,为膝关节 OA 患者提供了一种在家中进行康复锻炼的有效工具。 KneeBRIGHT 旨在通过引人入胜的 EMG 驱动的视频游戏疗法来激励膝关节 OA 患者进行定期的肌肉强化锻炼。
该计划的总体目标是通过有效和激励性的康复锻炼来改善膝关节 OA 的结果。 参与者将被随机分配到两组:(1) KneeBRIGHT 组; (2)标准康复组。 两组都将接受基线和后续评估,以测量患者报告的结果和大腿肌肉力量。 两组的参与者都将接受为期 12 周的计划,包括每周 3 次锻炼课程,包括面对面和在家锻炼的组合。 将比较干预前后的结果措施以探索有效性。 技术接受度也将在随机分配到 KneeBRIGHT 组的患者中进行研究。
研究概览
详细说明
骨关节炎 (OA) 是美国残疾的主要原因。 由于骨关节炎与下肢肌肉无力有关,因此以股四头肌和其他下肢肌肉强化为重点的康复治疗是膝骨关节炎患者行之有效的治疗方法。 然而,由于缺乏关于最佳方案的指导,以及在患者觉得乏味和无聊的重复性例程中参与度低,患者对锻炼程序的依从性很低。
本研究的长期目标是通过有效和激励性的康复锻炼来改善膝关节 OA 的结果。 用于基于游戏的家庭治疗的膝关节生物反馈康复接口(“KneeBRIGHT”)系统将肌电图(EMG)生物反馈与视频游戏疗法(VGT)相结合,为膝关节 OA 患者提供了一种在家中进行康复锻炼的有效工具。 KneeBRIGHT 旨在通过引人入胜的 EMG 驱动的视频游戏疗法来激励膝关节 OA 患者进行定期的肌肉强化锻炼。
年龄在 40-75 岁之间、能够独立行走、通过 X 光诊断为膝关节 OA 并且在 Kellgren-Lawrence OA 放射照相分类系统中得分至少为 2 分(满分 4 分)的参与者将被纳入研究. 患有精神或认知障碍(例如痴呆症)、有症状的脊柱、髋关节、踝关节或足部疾病(OA 除外)的参与者将被排除在外,这些疾病会干扰膝关节的评估。 患有平衡或前庭障碍、周围神经病变、妨碍 EMG 电极放置的皮肤状况、囚犯、孕妇(根据报告)、非英语国家、视力和/或听力受损的人也将被排除在外。
符合条件的参与者将被随机分配到两组:(1) KneeBRIGHT 组; (2)标准康复组。 两组都将接受基线和后续评估,以测量患者报告的结果和大腿肌肉力量。 两组的参与者都将接受为期 12 周的计划,包括每周 3 次锻炼课程,包括面对面和在家锻炼的组合
两组将接受相同的康复方案,该方案将从研究团队物理治疗师在诊所监督的会议开始,并逐渐增加家庭会议。 KneeBRIGHT 小组的参与者将通过基于视频游戏的活动进行股四头肌强化练习。 EMG 生物反馈装置和带笔记本电脑的视频游戏将提供给受试者以供家庭使用。 受试者将收到有关如何应用 EMG 生物反馈装置和使用视频游戏的说明。 KneeBRIGHT 游戏活动包括向玩家介绍虚拟世界和任务,玩家自定义个人头像并完成一系列校准收缩和练习练习以熟悉游戏控制。 通过 EMG 系统,玩家的肌肉收缩转化为化身的物理运动和虚拟环境中车辆的控制。 每个任务类型的挑战都旨在根据个人的身体状况允许以坐姿、仰卧、支撑站立或独立姿势进行游戏。 用户与游戏的互动包括膝盖伸展练习和功能性运动,可提供最佳治疗效果。
两组的参与者都将接受家庭和诊所课程的结合。 协议将从六次诊所访问开始,以最大限度地熟悉锻炼程序和设备。 康复 2 周后将增加家庭课程。 课程将包括热身、力量、平衡、精确和温和的伸展运动。 加强锻炼将集中在股四头肌、腿筋、小腿和臀肌上。 伸展运动将集中在股四头肌、腿筋和小腿肌肉上。 进展将以康复原则和参与者对练习的反应为指导。 这些练习的量将取决于它们使受试者感觉如何。 康复计划将允许受试者增加他们可以进行的运动量。 如果受试者感到不适,练习将受到限制。 总体而言,协议将包括总共 36 节课,20 节诊所课和 16 节家庭课。
将比较干预前后的结果措施以探索有效性。 技术接受度也将在随机分配到 KneeBRIGHT 组的患者中进行研究。
总体而言,KneeBRIGHT 有可能通过特定的、适应性锻炼的身体练习改善功能恢复,并通过有趣的游戏和表现反馈促进依从性,从而显着增强 OA 康复。 在远程治疗中使用 KneeBRIGHT 系统可能会增加对偏远/服务欠缺地区的访问,并扩大现有康复设施的范围。
统计分析 研究前通过综合 KOOS 评分评估的膝关节功能将与干预后记录的 KOOS 评分进行比较,以检验进行 KneeBRIGHT 锻炼的患者与对照组相比将显着改善膝关节功能的主要假设。 将从干预后分数中减去干预前 KOOS 分数测量值,以生成一组增量值。 这些增量值将通过协方差分析 (ANCOVA) 进行分析。 p≤0.05 决策规则将用作拒绝标准。
问卷结果将用于检验以下假设:与进行常规锻炼的患者相比,使用 KneeBRIGHT 系统的患者表现出更高的参与度。 将对问卷分数进行统计以产生综合分数。 这些综合分数将通过线性混合模型进行分析。 p≤0.05 决策规则将用作原假设拒绝标准。
通过将 KneeBRIGHT 系统的运动分钟数与对照组的标准运动方案的运动分钟数进行比较,分析家访的时间数据,以检验 KneeBRIGHT 系统的运动持续时间更长的假设。 每个系统的平均使用时间将通过学生配对 t 检验进行分析,P v≤0.05 作为原假设拒绝标准。
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Virginia
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Charlottesville、Virginia、美国、22903
- University of Virginia
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
纳入标准:
- 40-75岁
- 骨关节炎的诊断
- 无辅助器具独立行走
排除标准:
- 患有精神障碍或认知障碍(例如痴呆症)的个人会影响他们遵循指示或提供自愿同意的能力
- 有症状的脊柱、髋关节、踝关节或足部疾病,而不是会干扰膝关节评估的骨关节炎。
- 平衡或前庭障碍
- 周围神经病变
- 妨碍 EMG 电极放置的皮肤状况
- 囚犯
- 怀孕(根据报告)
- 非英语人士
- 有视力和/或听力障碍的人
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:KneeBright 组
该组的参与者将进行旨在提高肌肉力量、平衡性和准确性的练习。
参与者将每周进行 3 次练习,持续 12 周。
每个会话将持续一个小时。
一些练习将在玩视频游戏时使用 KneeBright 设备进行。
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KneeBRIGHT 小组将使用 KneeBright 设备,该设备包含一个 EMG 生物反馈界面软件,可指导用户完成日常锻炼。 无线 EMG 传感器包括两个小电极,可以粘在两侧的股四头肌上。 KneeBRIGHT 软件具有一个虚拟世界,在这个虚拟世界中,患者可以在特定于膝关节骨性关节炎康复的练习中使用 EMG 单元完成控制游戏中化身的挑战。 KneeBRIGHT 软件将结合各种加强股四头肌的练习,并将采用基于每日可调渐进阻力练习 (DAPRE) 技术的算法,然后使用这些组中执行的重复次数来确定适当的增加(或可能会降低)下一组/会话的目标阻力。 |
有源比较器:标准康复组
该组的参与者将以相同的重点和频率进行练习。
不会使用 KneeBright 设备进行任何锻炼。
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该组的参与者将接受基于标准诊所的膝关节康复。
两组将进行完全相同的练习,但是,该组不会使用 KneeBRIGHT 设备。
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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膝关节损伤和骨关节炎结果评分 (KOOS) 的变化
大体时间:KOOS 分数将在基线、第 1 天和干预结束时的第 12 周进行测量。
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KOOS 有 5 个分量表:症状、疼痛、运动、日常生活活动 (ADL) 和生活质量 (QOL)。
每个等级都以 0-100 分的等级表示,其中 100 = 感知到的膝关节功能最好,0 = 感知到的膝关节功能最差。
本研究的结果表示为治疗前后的变化分数,其中正分数表示每个 KOOS 子量表都有改善。
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KOOS 分数将在基线、第 1 天和干预结束时的第 12 周进行测量。
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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大腿肌肉力量测试的峰值扭矩变化
大体时间:将在第 1 天的基线和第 12 周的干预结束时测量峰值扭矩(肌肉力量)。
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将在基线和跟进时测量大腿肌肉力量。
参与者将被要求进行大腿肌肉(股四头肌/膝关节伸展)收缩,同时记录使用测力计(biodex 系统 4)测量的力量。
参与者将被要求进行重复的最大肌肉收缩,以测试测试肢体的膝盖伸展肌肉力量(单侧测试,对每个参与者测试一条大腿)。
我们记录了峰值扭矩,定义为膝关节伸展收缩期间达到的最大扭矩。
结果评分表示为治疗前后峰值扭矩的变化。
正数表示强度增加。
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将在第 1 天的基线和第 12 周的干预结束时测量峰值扭矩(肌肉力量)。
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合作者和调查者
出版物和有用的链接
一般刊物
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研究记录日期
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学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
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膝骨关节炎的临床试验
膝明集团的临床试验
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Case Western Reserve UniversityNational Institutes of Health (NIH); American Heart Association完全的
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Northern Illinois UniversityUniversity Autonoma de Santo Domingo终止