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临床试验/NCT03607721
NCT03607721已完成不适用

Accuracy of Markerless 3D Motion Capture Evaluation to Differentiate Between On/Off Status in Parkinson's Disease After Deep Brain Stimulation

Hospital Zambrano Hellion2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2017年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
12
试验地点
2
主要终点
Shoulder Flexion (right and left), Shoulder Extension (right and left), Internal Shoulder Rotation (right and left), External Shoulder Rotation (right and left), Maximum shoulder abduction (right and left)

研究概览

简要总结

Body motion evaluation (BME) by markerless systems is increasingly being considered as an alternative to traditional marker-based technology because they are faster, simpler, and less expensive. They are increasingly used in clinical settings in patients with movement disorders, however, the wide variety of systems available make results conflicting.

The objective of this study was to determine if a markerless 3D motion capture system is a useful instrument to objectively differentiate between Parkinons's Disease (PD) patients with Deep Brain Stimulation (DBS) in On and Off state and controls; and its correlation with the evaluation by means of Unified Parkinson's Disease Rating Scale (UPDRS).

Six PD patients who underwent DBS bilaterally in the subthalamic nucleus were evaluated using BME and UPDRS-III with DBS turned On and Off. BME of 16 different movements in six controls paired by age and sex was compared with PD patients with DBS in On and Off states.

Kinematic data obtained with this markerless system could contribute to the discrimination between PD patients and healthy controls. This emerging technology may help to clinically evaluate PD patients more objectively.

详细描述

Methodology. Patients. Six patients with PD, diagnosed in accordance with the United Kingdom Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria by a certified neurologist and movement disorder specialist, were included. This is a pilot study, and sample size was chosen by convenience, accessibility and proximity to the researchers. The study was approved by the investigator's institutional research board, and the patients and controls provided written consent. In the months preceding the test, the PD patients were clinically evaluated by the same physician according to the Unified Parkinson Disease Rating Scale section III or motor section (UPDRS-III).

Instrument. Actually, there are many markerless motion capture systems in the market, with a broad range of prices, as well as a broad range of reliability. However, DARI system has been proven to be one of the best for numerous reasons. This system requires a quick calibration at the beginning of each day that the technician can complete in less than 10 minutes. It does not have to be repeated until the following day, no matter how many patients are evaluated. The system depends on a computer-based software that acquires the patient's skeleton or avatar using eighteen high-speed cameras (120 Hz) placed around the room to collect whole body data and delivers kinematic analysis almost instantly using sophisticated biomechanical algorithms.

Also, traditional motion labs use cumbersome floor-mounted pressure plates to measure the forces generated by the body. These require frequent calibration and restrict the subject's movement to a limited area. DARI's kinetic capture system does not require force plates and can measure joint torques, ground reaction forces, and other measurements without restricting the subject's natural movement.

Markerless 3D motion capture evaluation of kinematics in the PD patients and controls was performed on a rectangle room that measures 6 x 6 meters and 3 meters in height. The room has a green screen on the floor, and eighteen cameras are strategically placed on the walls, twelve are placed 2.6 meters high and 6 are on a lower level at 30 centimeters from the ground. The room has ample space, which allows for broader movements to be analyzed.

Evaluations. PD patients were asked to arrive in the morning wearing dark close-fitting clothing, to skip their last PD medication, and with DBS in Off state for least 180 minutes. On PD patients, UPDRS-III evaluation was done first. Then, to begin the markerless body motion evaluation (BME), patients and controls' weight and height were entered into the system to help establish the locations of joint centers. Once inside the green room, subjects first stood with feet apart and arms outstretched to the side, while the system created a 3D silhouette of each participant's form and a biometric skeleton was acquired; this took no more than three seconds. For the BME, all subjects performed 16 different movements. This set of movements was especially designed to evaluate PD patients and contains items that are related to three major motor symptoms in this disease: rigidity, bradykinesia and postural instability; tremor is not possible to assess. Once the BME was done, PD patients were asked to turn their DBS to On state and wait 30 minutes before repeating both UPDRS-III and BME. Controls only performed the BME, which took no more than 20 minutes. PD patients were evaluated twice (DBS state On and Off) with a 1-hour wait in between; their evaluation altogether took approximately 1.5 hours. The data files were uploaded to DARI Motion Platform where the biomechanical analysis produced full-body kinematic results and, finally, these data were exported to Excel for statistical analysis.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with Diagnosis of Parkinson's Disease by United Kingdom Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria
  • Submitted to subthalamic DBS implantation a minimum of 3 months prior to the evaluation.

排除标准

  • Patients with physical disability (i.e. wheelchair, cane, assistance to daily living activities)
  • History of stroke and physical disability
  • Another neurological disorder other than PD
  • Recent head and limb trauma that limits movement
  • Treatment with antipsychotics or recent botulinum toxin treatment.

研究组 & 干预措施

DBS Patients Group

Experimental

Body Motion Evaluation DARI

干预措施: Body Motion Evaluation DARI (Device)

Control Group

Active Comparator

Body Motion Evaluation DARI

干预措施: Body Motion Evaluation DARI (Device)

结局指标

主要结局

Shoulder Flexion (right and left), Shoulder Extension (right and left), Internal Shoulder Rotation (right and left), External Shoulder Rotation (right and left), Maximum shoulder abduction (right and left)

时间窗: 1 day: Test is done twice. First with DBS in Off state and then repeated 1 hour after DBS has been turned to On state.

Measured by DARI Body Motion Analysis. Range of movement, measured in degrees.

Bilateral squat depth, Lunge Distance (right and left), Step Length (right and left), Step Width (right and left)

时间窗: 1 day: Test is done twice. First with DBS in Off state and then repeated 1 hour after DBS has been turned to On state.

Measured by DARI Body Motion Analysis. Range of movement, measured in centimeters.

Cadence

时间窗: 1 day: Test is done twice. First with DBS in Off state and then repeated 1 hour after DBS has been turned to On state.

Measured by DARI Body Motion Analysis. Measured in steps/minute.

Speed or velocity

时间窗: 1 day: Test is done twice. First with DBS in Off state and then repeated 1 hour after DBS has been turned to On state.

Measured by DARI Body Motion Analysis. Measured in meters/second.

Stride length

时间窗: 1 day: Test is done twice. First with DBS in Off state and then repeated 1 hour after DBS has been turned to On state.

Measured by DARI Body Motion Analysis. It is the distance between any two successive points of heel contact of the same foot. Measured in centimeters.

Trunk Rotation, Trunk Flexion, Trunk Extension

时间窗: 1 day: Test is done twice. First with DBS in Off state and then repeated 1 hour after DBS has been turned to On state.

Measured by DARI Body Motion Analysis. Range of movement, measured in degrees.

Anterior-posterior hip displacement, Medial-lateral hip displacement

时间窗: 1 day: Test is done twice. First with DBS in Off state and then repeated 1 hour after DBS has been turned to On state.

Measured by DARI Body Motion Analysis. Patients are asked to outstretch their arms to the sides, extend their neck and close their eyes during 10 seconds. The hip displacement that happens during this time is recorded and measured in centimeters.

次要结局

  • Speech(1 day: Test is done once with DBS in Off state.)
  • Facial Expression(1 day: Test is done once with DBS in Off state.)
  • Tremor at Rest(1 day: Test is done once with DBS in Off state.)
  • Action or Postural Tremor of Hands(1 day: Test is done once with DBS in Off state.)
  • Finger Taps(1 day: Test is done once with DBS in Off state.)
  • Hand Movements(1 day: Test is done once with DBS in Off state.)
  • Rapid Alternating Movements of Hands(1 day: Test is done once with DBS in Off state.)
  • Leg Agility(1 day: Test is done once with DBS in Off state.)
  • Rigidity(1 day: Test is done once with DBS in Off state.)
  • Arising from Chair(1 day: Test is done once with DBS in Off state.)
  • Posture(1 day: Test is done once with DBS in Off state.)
  • Gait(1 day: Test is done once with DBS in Off state.)
  • Postural Stability(1 day: Test is done once with DBS in Off state.)
  • Body Bradykinesia and Hypokinesia(1 day: Test is done once with DBS in Off state.)

研究者

发起方
Hospital Zambrano Hellion
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hector Ramon Martinez

Director of Instituto de Neurologia y Neurocirugia Hospital Zambrano Hellion

Hospital Zambrano Hellion

研究点 (2)

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