Influence of Assistive Soft-robotic Glove Use on Actual Arm Use in Daily Life
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Actual arm activity
研究概览
简要总结
This study, aimed at investigating the impact of using a supportive soft-robotic glove on actual arm and hand use in daily life, is designed as a single-case experimental design study. 3-5 patients with limitations in hand function due to trauma-related or neurological conditions are asked to participate. Participants will be asked to use a soft-robotic glove at home for six weeks during daily activities relevant to them, while that glove supports the grip of their most affected hand. For several weeks before, during and after the use of the soft-robotic glove, participants will be asked to do some short tests (wearing an activity meter on both wrists during the day, performing a hand squeeze test under the supervision of the researcher via video call) and to answer some questions related to perceived hand function and well-being (a total of at least 15 times during 12-14 weeks). The present study is a follow-up to previous studies that investigated the effect of (previous versions of) the same robotic glove (Carbonhand; Bioservo Technolo-gies AB, Kista, Sweden) on hand function, in order to better understand and explain the observed therapeutic effect.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
盲法说明
Masking is not possible
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 90 years
- •Experience difficulties in performing ADL due to hand function limitations as a result of trauma-related injury or neurologic disorder
- •Being in a chronic/stable phase of disease as judged by their physician
- •Able to activate the soft-robotic glove by generating pressure on finger/palm sensors when grasping an object
- •Ability to relax an active grip
- •Sufficient cognitive status to understand two-step instructions
- •Having (corrected to) normal vision
- •Able to provide written informed consent
- •Living independently
排除标准
- •Severe sensory problems of the most-affected hand
- •Severe acute pain of the most-affected hand
- •Wounds on the hands that can provide a problem when using the glove
- •Severe contractures limiting passive range of motion to the extent that the glove can't be donned/activated comfortably
- •Co-morbidities limiting functional use/performance of the arms and/or hands
- •Severe spasticity of the hand (≥2 points on Ashworth Scale)
- •Severe proximal weakness (MRC shoulder elevation<4)
- •Used the Carbonhand system in the past 3 months
- •Participation in other studies that can affect functional performance of the arm/hand
- •Receiving arm-/hand function therapy during the course of the study
- •Insufficient digital literacy to conduct video calls
- •Insufficient knowledge of the Dutch or English language to understand the purpose or methods of the study
研究组 & 干预措施
Baseline phase
Soft-robotic glove phase
干预措施: Carbonhand (Device)
Retention phase
结局指标
主要结局
Actual arm activity
时间窗: During home assessments: 15 times scheduled intermittently across 12-14 weeks (5x in each of the three study phases), while wearing the MotionWatch for a day during waking hours (ca. 12h).
The main study parameter is actual arm use as measured by two MotionWatch8 devices, containing an accelerometer, one around each wrist. In essence, the 'raw' accelerometer signal will be transformed into an 'activity count signal'. Actual amount of arm-hand use will then be calculated in several ways, focusing on the duration of use and the intensity of use of the affected arm-hand.
次要结局
- Grip strength(During home assessments: 15 times scheduled intermittently across 12-14 weeks (5x in each of the three study phases), with supervision by researcher on videocall)
- Michigan Hand Outcomes Questionnaire - Question 2 (MHQ-Q2)(During home assessments: 15 times scheduled intermittently across 12-14 weeks (5x in each of the three study phases))
- Positive Health questionnaire(During home assessments: 15 times scheduled intermittently across 12-14 weeks (5x in each of the three study phases))
- Glove use data(Continuously and automatically during soft-robotic glove use phase (6 weeks) when soft-robotic glove is turned on and activated.)
- Michigan Hand Outcome Questionnaire - Dutch Language Version (MHQ-DLV)(Thee times across 12-14 weeks during evaluations at the end of each study phase (between week 2-4, week 8-10, week 12-14, with exact scheduling depending on randomized length of baseline phase))
- Diary(Continuously during soft-robotic glove use phase (6 weeks) when soft-robotic glove is used)
- Jebsen-Taylor hand function test (JTHFT)(Thee times across 12-14 weeks during evaluations at the end of each study phase (between week 2-4, week 8-10, week 12-14, with exact scheduling depending on randomized length of baseline phase))
- Numerical Pain Rating Scale (NPRS)(Thee times across 12-14 weeks during evaluations at the end of each study phase (between week 2-4, week 8-10, week 12-14, with exact scheduling depending on randomized length of baseline phase))
- Short-Form (SF-36)(Thee times across 12-14 weeks during evaluations at the end of each study phase (between week 2-4, week 8-10, week 12-14, with exact scheduling depending on randomized length of baseline phase))
- Motor Activity Log (MAL)(Thee times across 12-14 weeks during evaluations at the end of each study phase (between week 2-4, week 8-10, week 12-14, with exact scheduling depending on randomized length of baseline phase))
- Euroqol-5D (EQ-5D)(Thee times across 12-14 weeks during evaluations at the end of each study phase (between week 2-4, week 8-10, week 12-14, with exact scheduling depending on randomized length of baseline phase))
- Semi-structured interview(One time across 12-14 weeks during evaluation at the end of the intervention phase (between week 8-10, with exact scheduling depending on randomized length of baseline phase))