Usability Study of an Active Smart Wearable Orthosis for Enhanched Rehabilitation Therapy in Stroke Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- Investigate user experience by a self-composed questionnaire.
研究概览
简要总结
The purpose of this study is to investigate the usability of a new upper limb robot assisted therapy device in stroke patients.
详细描述
The number of physically weak individuals is increasing, resulting in a higher burden on health care and health care workers. The use of robot assisted therapy (RAT) might partly solve this problem. Rehabilitation progress highly depends on training intensity and training duration, favouring the use of RAT.
In this pilot study, the usability of a new upper arm RAT device for upper arm rehabilitation in stroke patients is investigated. Myo-electrical signals will serve as input for the device, assisting the user in flexion and extension of the elbow, which is combined with a stabilizing shoulder brace and a bionic glove.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects:
- •Inclusion criteria:
- •Persons between 18 and 85 years old that can perform all sorts of daily activities with their upper limbs
- •Ability to sit on a chair with adequate trunk stability
- •Ability to follow verbal instructions
- •Ability to communicate verbally with the researchers
排除标准
- •Ever had a fracture in the upper limbs
- •Ever had a surgery in the upper limbs
- •Pain in the upper limbs obstructing the execution of daily activities with the upper limbs
- •Physical trauma in the two months preceding the research
- •Mental problems that make the execution of daily activities unreliable
- •(Chronic) subluxation of the shoulder joint
- •Secundary soft tissue problems which may complicate the research or make it impossible (e.g. shoulder impingement, musculoskeletal problems, sensory deficits)
- •Pregnancy
- •Pacemaker
- •Known allergies for one of the components of the ARTHE rehabilitation tool
- •Stroke patients:
- •Inclusion criteria:
- •Stroke patients, more than three months after onset
- •Aged between 18 and 85 years
- •None to moderate spasticity in the hemiplegic arm (Modified Ashworth Scale: 0-2)
- •Detectable voluntary muscle activity at elbow flexion and elbow extension of the hemiplegic arm (Medical research council score: 1-5)
- •Ability to sit on a chair with adequate trunk stability
- •Ability to follow verbal instructions
- •Ability to communicate verbally with the researchers
- •Exclusion criteria:
- •Stroke patients, less than three months after onset
- •Massive spastic patterns
- •Severe medical conditions that interfere with the proper execution of the research, patients who are medically unstable
- •Cognitive disorders which may complicate the research or make it impossible
- •Speaking disorders (aphasia, dysarthria) which may complicate the proper execution of the research and the communication of important verbal information
- •Visual disorders which may complicate the research or make it impossible
- •(Chronic) subluxation of the shoulder joint
- •Shoulder-hand-syndrom
- •Pusher syndrom
- •Secundary soft tissue problems which may complicate the research or make it impossible (e.g. shoulder impingement, musculoskeletal problems, sensory deficits)
- •Pregnancy
- •Pacemaker
- •Known allergies for one of the components of the ARTHE rehabilitation tool
研究组 & 干预措施
Healthy persons
Test upper limb robot assisted therapy device. During 1 session of 1/2 hour.
干预措施: Test upper limb robot assisted therapy device (Device)
Stroke patients
Training with new upper limb robot assisted therapy device. During 2 to 5 sessions of 1/2 hour.
干预措施: Training with new upper limb robot assisted therapy device (Device)
结局指标
主要结局
Investigate user experience by a self-composed questionnaire.
时间窗: Up to 30 minutes at the last session
Investigate user experience by a self-composed questionnaire with theorems where upon users have to score. Possible scores range from 1 (totally disagree) to 4 (totally agree).
次要结局
- Measure the rate of perceived exertion by the Borg scale.(Up to 5 minutes at the last session)
- Investigate whether wearing the device improves functionality by the Action Research Arm Test (ARAT).(Up to 5 weeks (at week 1, week 2 and week 5))
研究者
Lieven De Maesschalck
Innovation Manager
Thomas More Kempen