Usability Testing of a Bilateral Activities of Daily Exercise Robot for Stroke Therapy
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Motor Control as assessed by Fugl-Meyer assessment
研究概览
简要总结
In stroke rehabilitation, unilateral training of the impaired limb after stroke is often the frequent strategy used over bilateral ones. However, the clinical need for bilateral training is supported by evidence that shows that unilateral training of the impaired limb does not automatically restore bimanual coordination and function. Increased focused is needed on developing more robot-assisted therapy that can train the impaired arm bilaterally and unilaterally. Controlling these robots is often difficult and requires a better understanding of the coupling effects of the left and right hand before and after a stroke. There is a need to develop robot-assisted therapy devices that can address coupled and uncoupled bimanual movements as well as symmetry as well as asymmetry in context of human bimanual actions along with the intermanual division of labor in various ADL tasks. This study focuses on bilateral training and the use of bio-inspired control algorithms to understand impairment and recovery on Bimanual Activities of Daily Living (ADLs) by stroke subjects in terms of the arm kinematics. Healthy subjects and those with hemiplegia due to a stroke or cerebral palsy will be evaluated by a member of the research team and asked to perform a battery of tasks to test the viability and usability of a bilateral robot system called BiADLER, which allows patients to complete daily tasks with varying levels of assistance to adapt task performance to each individual subject's performance. Subjects will to provide feedback to the researchers on their observations and thoughts about the therapy devices.
详细描述
Subjects may be video-taped or photographed in any of the following sessions.
Part A: Participation in this part of the study will include the following steps:
- Informed Consent: After arrival, subjects will review and sign the consent form with study personnel present.
2a) Pre-Assessments: A member of the research team will evaluate the subjects' affected arm and assess their ability to use it. Subjects will be evaluated using a battery of assessments in order to determine their level of impairment such as the Upper Extremity Fugl-Meyer, Montreal Cognitive Assessment, Box in Block, and grip strength using a dynamometer, etc.
2b) Break: Subjects will be given a 15 minute break.
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
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Stroke and CP survivors greater than 18 years of age with hemiplegia and varying levels of impairment.
- •The subject's stroke must have occurred at least 3 months prior to enrollment in the study.
- •Healthy persons over the age of 18 with no upper limb impairment.
- •Low to mid functioning CP and stroke survivors greater than 18 years of age with hemiplegia.
- •The subject's stroke must have occurred at least 3 months prior to enrollment in the study.
排除标准
- •The Montreal Cognitive Assessment (MoCA) to each study participant. After the administration of the MoCA, the PI and research team member will use their to expertise and discretion to determine whether the participant scored well enough on particular components of the MOCA that are of particular concern to this study, e.g. visuospatial acuity and concentration.
- •Participants must be able to sit upright for 2 hours at a time in Part A of the study; and 2 hours at a time, 3 days a week, for Part B of the study.
- •Participants enrolled in Part B cannot currently be receiving rehabilitation.
- •Participants cannot have received Botox injections within the past 3 months.
- •Participants cannot be suffering from contractures (chronic loss of joint motion) or debilitating spasticity in the upper extremity or any other neuromuscular disease.
- •If a participant is experiencing greater than mild pain, and/or the PI determines that the participant should no longer continue working with the novel therapy devices, the study will be stopped.
研究组 & 干预措施
Stroke/CP survivors & healthy subjects
Part A: Stroke and CP survivors greater than 18 years of age with hemiplegia and varying levels of impairment. The subject's stroke must have occurred at least 3 months prior to enrollment in the study. Healthy persons over the age of 18 with no upper limb impairment.
Part B: Low to mid functioning CP and stroke survivors greater than 18 years of age with hemiplegia. The subject's stroke must have occurred at least 3 months prior to enrollment in the study. All will be asked to use the Bi-ADLER system.
干预措施: Bi-ADLER (Device)
结局指标
主要结局
Motor Control as assessed by Fugl-Meyer assessment
时间窗: The Fugl-Meyer assessment will be performed during the 1.5 hour long clinical evaluation at the beginning of the study and during the 1.5 hour long clinical evaluation at the conclusion of the study to assess change in motor control
Fugl-Meyer assessment will be performed by a physical therapist and will assess motor control of the subject.
Motor Control as assessed by Box and Block
时间窗: The Box and Block assessment will be performed during the 1.5 hour long clinical evaluation at the beginning of the study and during the 1.5 hour long clinical evaluation at the conclusion of the study to assess change in motor control
The Box and Block assessment will be performed by a member of the study team and will assess motor control by how many blocks that subject is able to move over a barrier.
Motor Control as assessed by Grip Strength
时间窗: The Grip Strength assessment will be performed during the 1.5 hour long clinical evaluation at the beginning of the study and during the 1.5 hour long clinical evaluation at the conclusion of the study to assess change in motor control
Grip strength will be measured by a dynamometer which clinically assesses motor control.
Bimanual activity quality as assessed by Ovalization Index
时间窗: In Part A, measured during one session, about 1.5 hours in length. For Part B, measured during 12 sessions about 1.5 hours in length
Ovalization Index : An Ovalization Index (OI) is defined to quantify the occurrence of lateral deviation when continuously drawing a straight vertical line. The strength of any bimanual coupling/interference effect was signaled by an increased OI value in the Non-congruent condition compared to the Congruent condition.
Bimanual activity quality as assessed by Task Completion Time
时间窗: In Part A, measured during one session, about 1.5 hours in length. For Part B, measured during 12 sessions about 1.5 hours in length
Task Completion Time (TCT): TCT is defined as the time in seconds that it takes to complete the task from initial button press to the final button press.
Bimanual activity quality as assessed by Euclidean Distance
时间窗: In Part A, measured during one session, about 1.5 hours in length. For Part B, measured during 12 sessions about 1.5 hours in length
Euclidean Distance : Relative distance (Euclidean) between the wrists positions of the left (non-dominant) and right (dominant) hands.
次要结局
- Phase Difference (PD)(In Part A, measured during one session, about 1.5 hours in length. For Part B, measured during 12 sessions about 1.5 hours in length)
- Mean Speed Smoothness(In Part A, measured during one session, about 1.5 hours in length. For Part B, measured during 12 sessions about 1.5 hours in length)
- Movement Overlap (MO)(In Part A, measured during one session, about 1.5 hours in length. For Part B, measured during 12 sessions about 1.5 hours in length)