Clinical trial NCT03607721: Accuracy of Markerless Motion Capture Evaluation in Parkinson's Disease After DBS
Official title: Accuracy of Markerless 3D Motion Capture Evaluation to Differentiate Between On/Off Status in Parkinson's Disease After Deep Brain Stimulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: deep brain stimulation
kinematics
markerless
body motion evaluation
gait analysis
Lead sponsor: INNCMZH
Sponsor class: UNKNOWN
First posted: 2018-07-31
Enrollment: 12
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants were divided in two groups: Parkinson's Disease patients that underwent deep brain stimulation and a control group with healthy subjects matched by age and gender.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Analysis. A paired t-test was used to compare mean changes in UPDRS-III between the On and Off state. Mean differences between groups were evaluated with ANOVA or Kruskal-Wallis tests depending of the distribution of the data of each independent variable. Post hoc analyses were made for pairwise comparison in statistically significant results. Bivariate correlations among evaluation modalities were examined. These correlations were examined in the On and Off state between UPDRS-III and BME items. To compare them as accurately as possible, the items on UPDRS-III and BME that were similar were correlated (e.g. rigidity in upper limbs from UPDRS-III was correlated with shoulder flexion, extension, rotation from BME). One of the correlations was hip displacement taken from BME, which analyzes balance by measuring the movement of hips when patients stand during 10 seconds with arms outstretched to the sides and eyes closed; this was correlated with posture stability item from UPDRS-III, which is a quick pull, reactionary intervention test where patient's response is measured. Because not all UPDRS-III items were measurable by DARI, seven out of 18 were correlated; however, all BME items were correlated with UPDRS-III global score. IBM SPSS Statistics 21.0 software was used for data analysis. A p-value of ≤0.05 was considered to indicate statistical significance.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: 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)
timeFrame: 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.
measure: Bilateral squat depth, Lunge Distance (right and left), Step Length (right and left), Step Width (right and left)
timeFrame: 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.
measure: Trunk Rotation, Trunk Flexion, Trunk Extension
timeFrame: 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.
measure: Anterior-posterior hip displacement, Medial-lateral hip displacement
timeFrame: 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.
measure: Cadence
timeFrame: 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.
measure: Speed or velocity
timeFrame: 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.
measure: Stride length
timeFrame: 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.
Secondary outcomes:
measure: Speech
timeFrame: 1 day: Test is done once with DBS in Off state.
measure: Facial Expression
timeFrame: 1 day: Test is done once with DBS in Off state.
measure: Tremor at Rest
timeFrame: 1 day: Test is done once with DBS in Off state.
measure: Action or Postural Tremor of Hands
timeFrame: 1 day: Test is done once with DBS in Off state.
measure: Rigidity
timeFrame: 1 day: Test is done once with DBS in Off state.
measure: Finger Taps
timeFrame: 1 day: Test is done once with DBS in Off state.
measure: Hand Movements
timeFrame: 1 day: Test is done once with DBS in Off state.
measure: Rapid Alternating Movements of Hands
timeFrame: 1 day: Test is done once with DBS in Off state.
measure: Leg Agility
timeFrame: 1 day: Test is done once with DBS in Off state.
measure: Arising from Chair
timeFrame: 1 day: Test is done once with DBS in Off state.
measure: Posture
timeFrame: 1 day: Test is done once with DBS in Off state.
measure: Gait
timeFrame: 1 day: Test is done once with DBS in Off state.
measure: Postural Stability
timeFrame: 1 day: Test is done once with DBS in Off state.
measure: Body Bradykinesia and Hypokinesia
timeFrame: 1 day: Test is done once with DBS in Off state.
Other outcomes:
Locations:
city: San Pedro Garza Garcia
country: Mexico
facility: Instituto de Neurologia y Neurocirugia Hospital Zambrano Hellion
state: NL
Study officials:
affiliation: Hospital Zambrano Hellion
name: Hector R Martinez, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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