Reliability of Sensor-Derived Measurements of the SENSorized Fugl-Meyer (FMA) in Subjects with Stroke Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Participants assessed by IMU
研究概览
简要总结
This study will be conducted at a single research center, the main objective of the study will be to evaluate the efficacy, safety, and accuracy of a medical device that has not yet been commercialized; therefore, it is still under development or testing and is not yet available for private use and is not for profit (nonprofit).
Fifty participants will be recruited from subjects afferent to the outpatient and inpatient neuro-motor rehabilitation clinics of IRCCS Fondazione Don Carlo Gnocchi in Florence, Italy, and afferent to the outpatient and inpatient rehabilitation clinics of Elias University Emergency Hospital in Bucharest, Romania.
In detail, it is deemed necessary to collect clinical and instrumental data. The study will be conducted by an interdisciplinary team composed of healthcare professionals and engineers afferent to the Department of Industrial Engineering.
Should you decide to participate in the study, a visit to verify the inclusion and exclusion criteria will be primarily conducted. Once the admission criteria have been verified, participants will undergo a series of assessments.
The first, involves the administration of some specific sections of the Fugl-Meyer scale (FMA), focusing on the upper extremities. Specifically, the following will be examined: section A for general upper limb function, section B assessing wrist mobility, and finally section D for limb coordination and speed.
During this phase, both upper limbs will be assessed, in addition, the first examiner will carefully place sensors on the participants and assign scores to the tests performed, according to the criteria established by the FMA scale.
Next, a second assessment (T1) will be conducted, in which a second examiner will be responsible for placing the sensors and recording data only on the most affected side.
At a third time, called "T2" and again with at least 15 minutes interval from T1, the first examiner will repeat the same assessments performed in "T1." While performing these assessments, a RealSense camera will be used.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •age 18 years or older;
- •stroke outcomes with the presence of sensorimotor impairment in the upper limb;
- •willingness to participate in the project, with informed consent signed by the person himself or, when necessary, by the support administrator/legal guardian.
排除标准
- •Severe concomitant pathologies that modify the subject's motor framework;
- •severe visual and/or hearing impairments that cannot be corrected;
- •severe neuropsychological impairments (aphasia, apraxia, other cognitive deficits ) such as to prevent cooperation in administering the scale;
- •presence of signs of clinical instability, defined by a score greater than zero on the SIC scale (Clinical Instability Scale).
研究组 & 干预措施
Stroke group
each participant will perform the FMA with IMU
干预措施: IMU and RealSense Cameras (Device)
结局指标
主要结局
Participants assessed by IMU
时间窗: at least 30 min from baseline
The Fugl-Meyer Assessment (FMA) is obtained with IMU and RealSense cameras. Below are the individual items of the FMA that will be acquired via the experimental kit: * A II. Voluntary movement in synergy: flexor synergy/extensor synergy * A III. Voluntary movement with mixed synergies: hand to lumbar spine/shoulder flexion 0- 90/pronation-supination * A IV. Voluntary movement with reduced or absent synergy: shoulder abduction 0-90/shoulder flexion 90-180/pronation-supination * B I. Wrist: stability at 15° dorsiflexion with elbow 90° * B II. Wrist: repeated dorsiflexion with elbow 90° * B III. Wrist: Stability at 15° dorsiflexion with elbow at 0° * B IV. Wrist: repeated dorsiflexion with elbow at 0° * D. Coordination/Speed: tremor * D. Coordination/Speed: dysmetria * D. Coordination/Speed: time
Participants assessed by IMU
时间窗: baseline
The Fugl-Meyer Assessment (FMA) is obtained with IMU and RealSense cameras. Below are the individual items of the FMA that will be acquired via the experimental kit: * A II. Voluntary movement in synergy: flexor synergy/extensor synergy * A III. Voluntary movement with mixed synergies: hand to lumbar spine/shoulder flexion 0- 90/pronation-supination * A IV. Voluntary movement with reduced or absent synergy: shoulder abduction 0-90/shoulder flexion 90-180/pronation-supination * B I. Wrist: stability at 15° dorsiflexion with elbow 90° * B II. Wrist: repeated dorsiflexion with elbow 90° * B III. Wrist: Stability at 15° dorsiflexion with elbow at 0° * B IV. Wrist: repeated dorsiflexion with elbow at 0° * D. Coordination/Speed: tremor * D. Coordination/Speed: dysmetria * D. Coordination/Speed: time
Participants assessed by IMU
时间窗: at least 15 min from baseline
The Fugl-Meyer Assessment (FMA) is obtained with IMU and RealSense cameras. Below are the individual items of the FMA that will be acquired via the experimental kit: * A II. Voluntary movement in synergy: flexor synergy/extensor synergy * A III. Voluntary movement with mixed synergies: hand to lumbar spine/shoulder flexion 0- 90/pronation-supination * A IV. Voluntary movement with reduced or absent synergy: shoulder abduction 0-90/shoulder flexion 90-180/pronation-supination * B I. Wrist: stability at 15° dorsiflexion with elbow 90° * B II. Wrist: repeated dorsiflexion with elbow 90° * B III. Wrist: Stability at 15° dorsiflexion with elbow at 0° * B IV. Wrist: repeated dorsiflexion with elbow at 0° * D. Coordination/Speed: tremor * D. Coordination/Speed: dysmetria * D. Coordination/Speed: time
次要结局
- Total FMA score(baseline)
- MODIFIED BARTHEL INDEX (mBI)(baseline)