PFI-RP: Smart Co-robot System for Cost-Effective Patient-Centered Robotic Rehabilitation
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Change From Baseline in Fugl-Meyer Arm (FMA) Motor Score
研究概览
简要总结
The goal of this study is to develop a clinically feasible, low-cost, nonsurgical neurorobotic system for restoring function to motor-impaired stroke survivors that can be used at the clinic or at home. Moreover, another goal is to understand how physical rehabilitation assisted by robotic device combined with electroencephalograph (EEG) can benefit adults who have had stroke to improve functions of their weaker arm.
The proposed smart co-robot training system (NeuroExo) is based on a physical upper-limb robotic exoskeleton commanded by a non-invasive brain machine interface (BMI) based on scalp EEG to actively include the participant in the control loop .
The study will demonstrate that the Neuroexo smart co-robot arm training system is feasible and effective in improving arm motor functions in the stroke population for their use at home.The NeuroExo study holds the promise to be cost-effective patient-centered neurorehabilitation system for improving arm functions after stroke.
详细描述
This study has two phases: The first phase will consist of baseline recordings for system calibration and training sessions to be conducted in a clinical setting. The second phase will consist of NeuroExo BMI-exo neurotherapy to be conducted at the participant's home. Throughout the study and after completion of the study, movement and brain activity will be analyzed to assess function of the affected upper extremity and changes in brain activity associated with the neurotherapy.
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
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •subjects between the ages of 20-65, male or female,
- •mild-to- moderate unilateral stroke confirmed by brain CT or MRI scan and manifested by a Glasgow Coma scale (GCS) score between 15 and 9 documented within 6 months,
- •the ability to perform 20deg of active wrist/elbow for upper limb robotic movement on the affected side, no planned alteration in lower/upper- extremity therapy/medication for muscle tone during course of study,
- •Anticipated length of needed acute interdisciplinary rehabilitation of 30 days or more.
- •Patients are required to have a MMSE>=24 to rule out those with cognitive impairments.
- •Patients will have to have normal/near normal strength in one upper/lower extremity and appreciable weakness in the other upper/lower extremity.
排除标准
- •history of traumatic brain injury prior to the current episode,
- •Severe neurologic or psychiatric condition preventing participation in rehabilitation and physical therapy activities (patients unable or unwilling to receive instruction and effectively complete a simple assigned task as determined by MMSE>=24 specified in inclusion criteria).
- •Women and minorities will be recruited as long as they meet the inclusion criteria.
研究组 & 干预措施
NeuroExo
NeuroExo is a device which includes a robotic exoskeleton that you were in your affected arm to assist you with arm movements, a headset that you wear on your head to measure your brain activity and detect your intention to move, and a graphical user interface that allows you to initiate and stop neurotherapy, and track your motor performance.
干预措施: NeuroExo co-robot neurorehabilitation system (Device)
结局指标
主要结局
Change From Baseline in Fugl-Meyer Arm (FMA) Motor Score
时间窗: Baseline, immediately after end of treatment (within a week), and 4 weeks after end of treatment
FMA is a stroke-specific, performance based impairment index. It quantitatively measures impairment based on Twitchell and Brunnstrom's concept of sequential stages of motor return in hemiplegic stroke patients. It uses an ordinal scale for scoring of 33 items for the upper limb component of the F-M scale (0:can not perform; 1:can perform partially; 2:can perform fully). Total range is 0-66, 0 being poor and 66 normal.
Movement Quality as Assessed by Exoskeleton Kinematics - Time to First Peak
时间窗: Baseline, immediately after end of treatment (within a week), and 4 weeks after end of treatment
Time to 1st Peak is a metric related to the shape of the velocity profile, and is reported as \[(time to first peak) divided by (total movement duration)\]. This value is usually less than the ideal value of 0.5, or 50%, of the total movement duration when a movement has more than one peak. The closer the value is to the ideal value of 0.5, the more well-balanced are the movements.
Cortical Dynamics Measured by Electroencephalography (EEG) Movement-related Cortical Potential (MRCP) Latency
时间窗: Baseline, immediately after end of treatment (within a week), and 4 weeks after end of treatment
EEG activity in the low-frequency delta band will be assessed. Scalp EEG electrodes will be located over the motor cortex, specifically, central (Cz, C1- C4), fronto- central (FCz, FC1 - FC4) and centro-parietal electrodes (CPz, CP1 - CP4). Further, to account for left hand vs. right hand impairment, the electrode locations will be flipped for individuals with right hand impairment. MRCP latency is the duration of MRCP prior to movement onset, and is defined as time difference starting from 50% of peak amplitude until the time of movement onset. Increased MRCP latency indicates increased activation of the ipsi-lesional hemisphere or inhibition of competing contra-lesional hemisphere, following motor relearning.
Movement Quality as Assessed by Exoskeleton Kinematics - Number of Peaks
时间窗: Baseline, immediately after end of treatment (within a week), and 4 weeks after end of treatment
Number of peaks is a metric related to the shape of the velocity profile. A higher number of peaks implies jerkier movement. A lower number of peaks indicates better movement quality (that is, movements are less jerky).
Neural Activity (Cortical Dynamics) Measured by Electroencephalography (EEG) Movement-related Cortical Potential (MRCP) Amplitude
时间窗: Baseline, immediately after end of treatment (within a week), and 4 weeks after end of treatment
EEG activity in the delta, theta, alpha, beta and gamma bands will be assessed. Scalp EEG electrodes will be located over the motor cortex, specifically, central (Cz, C1- C4), fronto- central (FCz, FC1 - FC4) and centro-parietal electrodes (CPz, CP1 - CP4). Further, to account for left hand vs. right hand impairment, the electrode locations will be flipped for individuals with right hand impairment. Increased MRCP amplitude indicates increased activation of the ipsi-lesional hemisphere or inhibition of competing contra-lesional hemisphere, following motor relearning.
Movement Quality as Assessed by Exoskeleton Kinematics
时间窗: Baseline, immediately after end of treatment (within a week), and 4 weeks after end of treatment
A higher value indicates better movement quality.
次要结局
- Grip Strength(Baseline, immediately after end of treatment (within a week), and 4 weeks after end of treatment)
- Pinch Strength(Baseline, immediately after end of treatment (within a week), and 4 weeks after end of treatment)
- Score on Action Research Arm Test (ARAT)(Baseline, immediately after end of treatment (within a week), and 4 weeks after end of treatment)
- Score on Jebsen-Taylor Hand Function Test (JTHFT)(Baseline, immediately after end of treatment (within a week), and 4 weeks after end of treatment)
研究者
Jose L.Contreras-Vidal, Ph.D.
Hugh Roy and Lillie Cranz Cullen Distinguished Professor
University of Houston