ArmeoSenso - Rewarding vs. Non-rewarding Therapy of Patients With Arm Impairments Based on Wearable Movement Sensors
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 38
- 试验地点
- 5
- 主要终点
- Change in ArmeoSenso - hand workspace
研究概览
简要总结
This study investigates the use of motivating/rewarding features in a computer based arm rehabilitation program. Half of the subjects will take part, besides receiving standard therapy, in a computer based program delivering a game like scenario with visual effects and monetary rewards in case of successful level completion, while the other half will take part in a similar program without visual effects or the possibility to earn money.
详细描述
Rewards not only increase motivation to train, but have also been shown to influence motor skill learning via activation of dopaminergic brain structures. In goal oriented tasks, receiving information about goal achievement has a rewarding value, which is further increased if performance has monetary consequences. Computer games often strengthen this kind of information by presenting explosions and other salient stimuli when a goal is achieved (e.g. a target has been reached). The current study investigates the outcome of an arm rehabilitation program, based on such a computer game delivered in two versions. Stroke patients are asked to use their impaired arms to perform goal oriented movements. Movements are translated into movements of a virtual arm on a computer screen. Goals are "meteors", threatening to destroy a planet on which they fall, if not caught by the virtual arm. One version of the computer game delivers state of the art graphics including a number of visual effects and, if the planet was protected successfully, information about a monetary reward, whereas the other version of the program delivers schematic graphic objects only. Training time and intensity are kept constant and outcome measures, including standard clinical motor assessments, are compared between the groups.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •stroke survivor (max. 100 days post-stroke)
- •upper extremity motor deficits
- •patient can lift the paretic arm against gravity
- •patient can move the hand at least 20x20 cm in a horizontal plane
- •patient is able and willing to participate
- •patient has signed informed consent
排除标准
- •severe aphasia (impairing verbal instructions)
- •severe dementia (impairing the capability to understand instructions)
- •severe depression (impairing motivation to train)
- •relevant (in the judgement of the investigator) impairment of visual perception, (impairing perception of goals and feedback on the computer screen)
结局指标
主要结局
Change in ArmeoSenso - hand workspace
时间窗: Assessed for each training visit (i.e., 15 visits over 3 weeks between day 2 and day 22): Main outcome is the change in hand workspace over the training intervention.
The subject moves the affected arm as far as possible in all directions while sitting in a gaming position. Movement range is recorded.
次要结局
- Wolf Motor Function Test(Baseline (day 1), post-training (day 23 ± 5 days) and 3 months post-training (day 113 ± 7 days); training lasts for 3 weeks (15 visits, one per workday))
- ArmeoSenso: pointing task(Assessed for each training visit (i.e., 15 visits over 3 weeks between day 2 and day 22))
- Motivation questionnaire(Assessed for each training visit (i.e., 15 visits over 3 weeks between day 2 and day 22))
- Box and Blocks Test(Baseline (day 1), post-training (day 23 ± 5 days) and 3 months post-training (day 113 ± 7 days); training lasts for 3 weeks (15 visits, one per workday))
- Motor Activity Log 14 (MAL-14)(Baseline (day 1), post-training (day 23 ± 5 days) and 3 months post-training (day 113 ± 7 days); training lasts for 3 weeks (15 visits, one per workday))
- NIHSS(Baseline (day 1), post-training (day 23 ± 5 days) and 3 months post-training (day 113 ± 7 days); training lasts for 3 weeks (15 visits, one per workday))
- Fugl-Meyer Assessment Upper Extremity(Baseline (day 1), post-training (day 23 ± 5 days) and 3 months post-training (day 113 ± 7 days); training lasts for 3 weeks (15 visits, one per workday))
- Barthel Index(Baseline (day 1), post-training (day 23 ± 5 days) and 3 months post-training (day 113 ± 7 days); training lasts for 3 weeks (15 visits, one per workday))