Robot-assisted Hand Training (Amadeo) Compared With Conventional Physiotherapy Techniques in Chronic Ischemic Stroke Patients: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 3
- 主要终点
- Impairment Based Arm Measures - Change in Upper Extremity Portion of the Fugl Meyer
研究概览
简要总结
Weakness is a major cause of disability in stroke survivors. Rehabilitation techniques are often not effective in restoring full function of the upper limb. Specifically, many individuals remain with weakness in the hand, preventing its return to full use.
Robotic therapies have been developed as exercise tools for stroke survivors. Devices, such as the InMotion2, have been shown to be useful in restoring some motor function in the upper limb. However, most existing devices designed to be used with the upper limb have primarily been developed to treat the shoulder, elbow and wrist. They have not specifically addressed hand function.
Tyromotion, Inc. has developed the Amadeo, which is primarily intended to provide rehabilitation for patients with neurological or orthopedic deficits in hand function. Initial clinical testing has demonstrated the practicality of using this device in a population of stroke survivors, although further research is needed to better understand the usefulness of the Amadeo device as compared with conventional rehabilitation methods. The purpose of this study was to compare results of training with the Amadeo device or training with conventional therapies.
A total of 28 subjects from two separate sites participated in the study and underwent baseline testing of upper limb motor and sensory performance and function. Subjects were then assigned to one of two treatment groups with a 50:50 chance of being in either group. One group underwent training with the Amadeo device and the other group underwent training with conventional therapy. All training sessions were 60 minutes in duration, three days/week for eight weeks (24 total sessions). Subjects were reassessed on completion of the training program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •history of stroke (>3 months from time of ictus)
- •paresis or plegia of the upper extremity.
排除标准
- •severe spasticity (defined on the Ashworth Scale with a score of 4-5)
- •severe pain despite conventional pain therapy of the paretic upper extremity
- •swelling, infection, fracture or ulcers of the paretic extremity
- •arthritis of the hand joints
- •botulinum toxin- therapy to the upper extremity within 3 months prior to study entry
- •severe contractions
结局指标
主要结局
Impairment Based Arm Measures - Change in Upper Extremity Portion of the Fugl Meyer
时间窗: Through study completion, an average of 8 weeks (at baseline and at the 8-week completion point)
quantitative performance measure (scale ranging from 0 (minimum) to 66 (maximum) points) of arm and hand impairment. A higher score represents more skilled movements of the arm and hand.
次要结局
- Change in Hand and Pinch Strength(Through study completion, an average of 8 weeks)
- Change in Range of Motion Measures(Through study completion, an average of 8 weeks)
- Change in Hand Dexterity(Through study completion, an average of 8 weeks)
- Change in Motor Activity Log Amount(Through study completion (taken at baseline and at 8-week study completion))
- Change in Mobility and Activities of Daily Living(Through study completion (taken at baseline and at 8 week study completion))
- Change in Spasticity Measures(Through study completion, an average of 8 weeks)
- Change in Motor Activity Log How Well(Through study completion (taken at baseline and on 8 week study completion))
研究者
Joel Stein
Department of Rehabilitation and Regenerative Medicine Chair
Columbia University