NCT03607721

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable parkinson-disease

Timeline
Completed

Started Mar 2017

Shorter than P25 for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

July 4, 2018

Completed
27 days until next milestone

First Posted

Study publicly available on registry

July 31, 2018

Completed
Last Updated

July 31, 2018

Status Verified

July 1, 2018

Enrollment Period

4 months

First QC Date

July 4, 2018

Last Update Submit

July 23, 2018

Conditions

Keywords

deep brain stimulationkinematicsmarkerlessbody motion evaluationgait analysis

Outcome Measures

Primary Outcomes (7)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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 Outcomes (14)

  • 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.

  • Rigidity

    1 day: Test is done once with DBS in Off state.

  • +9 more secondary outcomes

Study Arms (2)

DBS Patients Group

EXPERIMENTAL

Body Motion Evaluation DARI

Device: Body Motion Evaluation DARI

Control Group

ACTIVE COMPARATOR

Body Motion Evaluation DARI

Device: Body Motion Evaluation DARI

Interventions

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

Control GroupDBS Patients Group

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto de Neurologia y Neurocirugia Hospital Zambrano Hellion

San Pedro Garza García, Nuevo León, 66278, Mexico

Location

Related Publications (14)

  • 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.

    PMID: 24595273BACKGROUND
  • 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. Annu Int Conf IEEE Eng Med Biol Soc. 2014;2014:3126-9. doi: 10.1109/EMBC.2014.6944285.

    PMID: 25570653BACKGROUND
  • 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.

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

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 22074315BACKGROUND
  • 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.

    PMID: 27871019BACKGROUND
  • 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.

    PMID: 24560691BACKGROUND
  • 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.

    PMID: 24375990BACKGROUND
  • 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. doi: 10.1007/s00221-004-2036-5. Epub 2004 Oct 22.

    PMID: 15502989BACKGROUND
  • 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.

    PMID: 25082782BACKGROUND
  • 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.

    PMID: 20655750BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Hector R Martinez, MD, PhD

    Hospital Zambrano Hellion

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Instituto de Neurologia y Neurocirugia Hospital Zambrano Hellion

Study Record Dates

First Submitted

July 4, 2018

First Posted

July 31, 2018

Study Start

March 1, 2017

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

July 31, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations