Accuracy of Markerless Motion Capture Evaluation in Parkinson's Disease After DBS

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03607721
• Other study ID #: DARI-DBS
• Status: Completed
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: July 1, 2017

Study information

• Verified date: July 2018
• Source: Instituto de Neurologia y Neurocirugia Hospital Zambrano Hellion
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: July 1, 2017
• Est. primary completion date: July 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Device:
• Body Motion Evaluation DARI
Dynamic Athletic Research Institute (DARI) Software to evaluate motion tridimensionally with a camera system and without the use of body sensors.

Locations

Country	Name	City	State
Mexico	Instituto de Neurologia y Neurocirugia Hospital Zambrano Hellion	San Pedro Garza Garcia	NL

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Neurologia y Neurocirugia Hospital Zambrano Hellion

Country where clinical trial is conducted

Mexico, 

References & Publications (14)

Bovonsunthonchai S, Vachalathiti R, Pisarnpong A, Khobhun F, Hiengkaew V. Spatiotemporal gait parameters for patients with Parkinson's disease compared with normal individuals. Physiother Res Int. 2014 Sep;19(3):158-65. doi: 10.1002/pri.1579. Epub 2013 Dec 23. — View Citation

Ceseracciu E, Sawacha Z, Cobelli C. Comparison of markerless and marker-based motion capture technologies through simultaneous data collection during gait: proof of concept. PLoS One. 2014 Mar 4;9(3):e87640. doi: 10.1371/journal.pone.0087640. eCollection 2014. — View Citation

Chen SW, Lin SH, Liao LD, Lai HY, Pei YC, Kuo TS, Lin CT, Chang JY, Chen YY, Lo YC, Chen SY, Wu R, Tsang S. Quantification and recognition of parkinsonian gait from monocular video imaging using kernel-based principal component analysis. Biomed Eng Online. 2011 Nov 10;10:99. doi: 10.1186/1475-925X-10-99. — View Citation

Dewey DC, Miocinovic S, Bernstein I, Khemani P, Dewey RB 3rd, Querry R, Chitnis S, Dewey RB Jr. Automated gait and balance parameters diagnose and correlate with severity in Parkinson disease. J Neurol Sci. 2014 Oct 15;345(1-2):131-8. doi: 10.1016/j.jns.2014.07.026. Epub 2014 Jul 19. — View Citation

Espy DD, Yang F, Bhatt T, Pai YC. Independent influence of gait speed and step length on stability and fall risk. Gait Posture. 2010 Jul;32(3):378-82. doi: 10.1016/j.gaitpost.2010.06.013. Epub 2010 Jul 23. — View Citation

Ferrarin M, Rizzone M, Bergamasco B, Lanotte M, Recalcati M, Pedotti A, Lopiano L. Effects of bilateral subthalamic stimulation on gait kinematics and kinetics in Parkinson's disease. Exp Brain Res. 2005 Jan;160(4):517-27. Epub 2004 Oct 22. — View Citation

Fry AC, Herda TJ, Sterczala AJ, Cooper MA, Andre MJ. Validation of a motion capture system for deriving accurate ground reaction forces without a force plate. Big Data Anal. 2016;1(1):11. doi:10.1186/s41044-016-0008-y.

Galna B, Barry G, Jackson D, Mhiripiri D, Olivier P, Rochester L. Accuracy of the Microsoft Kinect sensor for measuring movement in people with Parkinson's disease. Gait Posture. 2014 Apr;39(4):1062-8. doi: 10.1016/j.gaitpost.2014.01.008. Epub 2014 Jan 22. — View Citation

Moodie P. Validation : Reviewing 3D Motion Capture Technology Types and What the Gold Standard Should Be for Human Movement . Lenexa, Kansas

Mündermann L, Anguelov D, Corazza S, Chaudhari AM, Andriacchi TP. Validation of a markerless motion capture system for the calculation of lower extremity kinematics.; 2005.

Perrott MA, Pizzari T, Cook J, McClelland JA. Comparison of lower limb and trunk kinematics between markerless and marker-based motion capture systems. Gait Posture. 2017 Feb;52:57-61. doi: 10.1016/j.gaitpost.2016.10.020. Epub 2016 Oct 31. — View Citation

Rocha AP, Choupina H, Fernandes JM, Rosas MJ, Vaz R, Silva Cunha JP. Parkinson's disease assessment based on gait analysis using an innovative RGB-D camera system. Conf Proc IEEE Eng Med Biol Soc. 2014;2014:3126-9. doi: 10.1109/EMBC.2014.6944285. — View Citation

Rosengarden S, Docking S, Wassom D, Moodie N. The long term repeatability of a 3D markerless motion capture system and the implications it has on healthcare. J Appl Hum Mov. 2015;1(1):21-25.

Wassom D, Fry A, Moodie N. Repeatability of 3D markerless motion capture and how it could affect between-session variability. J Appl Hum Mov. 2015;1(1):21-25.

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Measured by DARI Body Motion Analysis. Range of movement, measured in degrees.	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.
Primary	Bilateral squat depth, Lunge Distance (right and left), Step Length (right and left), Step Width (right and left)	Measured by DARI Body Motion Analysis. Range of movement, measured in centimeters.	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.
Primary	Trunk Rotation, Trunk Flexion, Trunk Extension	Measured by DARI Body Motion Analysis. Range of movement, measured in degrees.	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.
Primary	Anterior-posterior hip displacement, Medial-lateral hip displacement	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.	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.
Primary	Cadence	Measured by DARI Body Motion Analysis. Measured in steps/minute.	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.
Primary	Speed or velocity	Measured by DARI Body Motion Analysis. Measured in meters/second.	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.
Primary	Stride length	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.	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	Speech	Unified Parkinson's Disease Rating Scale Section III (motor examination). Score ranges from 0-4 where 0 is normal and 4 is unintelligible.	1 day: Test is done once with DBS in Off state.
Secondary	Facial Expression	Unified Parkinson's Disease Rating Scale Section III (motor examination). Score ranges from 0-4 where 0 is normal and 4 is severe or complete loss of facial expression.	1 day: Test is done once with DBS in Off state.
Secondary	Tremor at Rest	Unified Parkinson's Disease Rating Scale Section III (motor examination). Head, upper and lower extremities. Score ranges from 0-4 where 0 is absent and 4 is marked in amplitude and present most of the time.	1 day: Test is done once with DBS in Off state.
Secondary	Action or Postural Tremor of Hands	Unified Parkinson's Disease Rating Scale Section III (motor examination). Score ranges from 0-4 where 0 is absent and 4 is marked in amplitude and interferes with feeding.	1 day: Test is done once with DBS in Off state.
Secondary	Rigidity	Unified Parkinson's Disease Rating Scale Section III (motor examination). Judged on passive movement of major joints with patient relaxed in a sitting position. Score ranges from 0-4 where 0 is absent and 4 is severe, range of motion achieved with difficulty.	1 day: Test is done once with DBS in Off state.
Secondary	Finger Taps	Unified Parkinson's Disease Rating Scale Section III (motor examination). Tapping of thumb and index finger in rapid succession. Score ranges from 0-4 where 0 is normal and 4 is can barely perform the task.	1 day: Test is done once with DBS in Off state.
Secondary	Hand Movements	Unified Parkinson's Disease Rating Scale Section III (motor examination). Opening and closing hands in rapid succession. Score ranges from 0-4 where 0 is normal and 4 is can barely perform the task.	1 day: Test is done once with DBS in Off state.
Secondary	Rapid Alternating Movements of Hands	Unified Parkinson's Disease Rating Scale Section III (motor examination). Pronation-supination in rapid succession. Score ranges from 0-4 where 0 is normal and 4 is can barely perform the task.	1 day: Test is done once with DBS in Off state.
Secondary	Leg Agility	Unified Parkinson's Disease Rating Scale Section III (motor examination). Tapping heel on the ground in rapid succession picking up entire leg. Score ranges from 0-4 where 0 is normal and 4 is can barely perform the task.	1 day: Test is done once with DBS in Off state.
Secondary	Arising from Chair	Unified Parkinson's Disease Rating Scale Section III (motor examination). Patient attempts to rise from straight-backed chair with arms folded across chest. Score ranges from 0-4 where 0 is normal and 4 is unable to arise without help.	1 day: Test is done once with DBS in Off state.
Secondary	Posture	Unified Parkinson's Disease Rating Scale Section III (motor examination). Score ranges from 0-4 where 0 is normal, erect and 4 is marked flexion with extreme abnormality of posture.	1 day: Test is done once with DBS in Off state.
Secondary	Gait	Unified Parkinson's Disease Rating Scale Section III (motor examination). Score ranges from 0-4 where 0 is normal and 4 is cannot walk at all, even with assistance.	1 day: Test is done once with DBS in Off state.
Secondary	Postural Stability	Unified Parkinson's Disease Rating Scale Section III (motor examination). Response to sudden, strong posterior displacement produced by pull on shoulders while patient erect with eyes open and feet slightly apart. Score ranges from 0-4 where 0 is normal and 4 is unable to stand without assistance.	1 day: Test is done once with DBS in Off state.
Secondary	Body Bradykinesia and Hypokinesia	Unified Parkinson's Disease Rating Scale Section III (motor examination). Combination of slowness, hesitancy, decreased arm swing, small amplitude, and poverty of movement in general. Score ranges from 0-4 where 0 is normal and 4 is unable to stand without assistance.	1 day: Test is done once with DBS in Off state.