MyHand: An Active Hand Orthosis for Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Score on Action Research Arm Test (ARAT)
研究概览
简要总结
This study seeks to explore the efficacy of several control mechanisms for the device and the impact of a device training program on its utility as a neuroprosthetic and training tool for upper limb recovery.
详细描述
Hand rehabilitation through occupational therapy is critical for many stroke survivors, but it is also greatly limited by insurance coverage, shortage of therapists, and logistic constraints. To address this, stroke patients need a rehabilitation method they can use on their own, without direct clinical supervision, and for activities of daily living. MyHand is a wearable and active hand orthosis consisting of a glove and forearm splint, equipped with actuators and tendons which connect to the fingers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Subjects are assessed by an independent therapist. The therapist is not blinded to the control mechanism used during treatment.
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
- •Subjects over 18 years of age
- •History of stroke resulting in significant upper limb impairment
- •Full passive range of motion
- •Gross control of the proximal upper extremity
- •Lacks timely grasp/release
- •No more than moderate flexor tone
- •Intact cognition
- •Exclusion criteria include:
- •Other Neurological/orthopedic disorders
- •Excessive spasticity/contracture
排除标准
- 未提供
结局指标
主要结局
Score on Action Research Arm Test (ARAT)
时间窗: Baseline; Post-test at Week 4
The ARAT is a 19-item measure that assesses upper limb functioning. The ARAT is divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement). Performance on each item is rated on a 4-point ordinal scale ranging from 0 (cannot perform) to 3 (normal performance). Scores on the ARAT range from 0-57 points, with higher scores indicating better performance.
Score on the Upper Extremity Component of the Fugl-Meyer Scale (UEFM)
时间窗: Baseline; Post-test at Week 4
The Fugl-Meyer (FM) Assessment of Motor Recovery evaluates and measures recovery in post-stroke hemiplegic patients. The FM uses a 3-point ordinal scale from 0 (cannot perform) to 2 (performs fully). The FM has 5 domains with a maximum score of 226 points. Subscales can be administered with out using the full FM. The Upper Extremity component (UEFM) consists of 33 items with a score range of 0-66. Higher score indicate better performance. Please note: An a prior decision was made to only perform the UEFM once at post-testing: post test without robotic assistance. The UEFM assesses capacity of the arm primarily through gross motor tasks, and comparatively few grasping and pinching tasks. Thus, it was presumed that robotic assistance would have minimal influence on UEFM scores. In other words, the UEFM was intended as a outcome measure to primarily evaluate the rehabilitative effects of training with the device, as opposed to evaluating the assistive capacity of using the device.
次要结局
- Score on Modified Ashworth Scale (MAS)(Baseline)
- Score on Box and Blocks Test (BBT)(Baseline; Post-test at Week 4)
- Number of Participants Completing Treatment Protocol(4 Weeks)
- Total Number of Adverse Events During Intervention(4 Weeks)
研究者
Joel Stein, MD
Simon Baruch Professor of Physical Medicine and Rehabilitation
Columbia University