Parkinson DiseaseNCT03607721
Accuracy of Markerless Motion Capture Evaluation in Parkinson's Disease After DBS
A study testing Body Motion Evaluation DARI in people with Parkinson Disease, run by Hospital Zambrano Hellion at 1 site in Mexico.
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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Body Motion Evaluation DARI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteMexico
- Study dates
- 1 Mar 2017to 1 Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Instituto de Neurologia y Neurocirugia Hospital Zambrano Hellion
San Pedro Garza García, Nuevo León, 66278
About this study
Official title: Accuracy of Markerless 3D Motion Capture Evaluation to Differentiate Between On/Off Status in Parkinson's Disease After Deep Brain Stimulation
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).
Read more
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.
Read the 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.
- Conditions
- Parkinson Disease
- Being tested
- Body Motion Evaluation DARI
- Keywords
- deep brain stimulation, kinematics, markerless, body motion evaluation, gait analysis
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Body Motion Evaluation DARIDevice
Dynamic Athletic Research Institute (DARI) Software to evaluate motion tridimensionally with a camera system and without the use of body sensors.
| Study group | Role | What they receive |
|---|---|---|
| DBS Patients Group | Experimental | Body Motion Evaluation DARI Receives: Device: Body Motion Evaluation DARI |
| Control Group | Active comparator | Body Motion Evaluation DARI Receives: Device: Body Motion Evaluation DARI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Unified Parkinson's Disease Rating Scale Section III (motor examination). Score ranges from 0-4 where 0 is normal and 4 is unintelligible.
Measured: 1 day: Test is done once with DBS in Off state.
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.
Measured: 1 day: Test is done once with DBS in Off state.
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.
Measured: 1 day: Test is done once with DBS in Off state.
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.
Measured: 1 day: Test is done once with DBS in Off state.
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.
Measured: 1 day: Test is done once with DBS in Off state.
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.
Measured: 1 day: Test is done once with DBS in Off state.
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.
Measured: 1 day: Test is done once with DBS in Off state.
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.
Measured: 1 day: Test is done once with DBS in Off state.
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.
Measured: 1 day: Test is done once with DBS in Off state.
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.
Measured: 1 day: Test is done once with DBS in Off state.
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.
Measured: 1 day: Test is done once with DBS in Off state.
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.
Measured: 1 day: Test is done once with DBS in Off state.
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.
Measured: 1 day: Test is done once with DBS in Off state.
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.
Measured: 1 day: Test is done once with DBS in Off state.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2018
- Study start1 Mar 2017
- Primary completion1 Jul 2017
- Study completion1 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Zambrano Hellion
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hector Ramon Martinez, Hospital Zambrano Hellion
- Investigators
- Hector R Martinez, MD, PhD, Principal investigator, Hospital Zambrano Hellion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03607721
- Sponsor's protocol ID
- DARI-DBS
- Status last verified
- Jul 2018
- First submitted
- 4 Jul 2018
- Last updated
- 31 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24595273Rocha 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.
PubMed 25570653Fry 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.
Moodie P. Validation : Reviewing 3D Motion Capture Technology Types and What the Gold Standard Should Be for Human Movement . Lenexa, Kansas
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.
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.
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.
PubMed 22074315Perrott 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.
PubMed 27871019Galna 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.
PubMed 24560691Bovonsunthonchai 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.
PubMed 24375990Ferrarin 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.
PubMed 15502989Dewey 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.
PubMed 25082782Espy 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.
PubMed 20655750
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Markerless 3D Motion Capture Evaluation to Differentiate Between On/Off Status in Parkinson's Disease After Deep Brain Stimulation
- ClinicalTrials.gov ID
- NCT03607721
- Acronym / sponsor ID
- DARI-DBS
- Conditions
- Parkinson Disease
- Keywords
- deep brain stimulation, kinematics, markerless, body motion evaluation, gait analysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Hospital Zambrano HellionUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 1 Jul 2017 (actual)
- Study completion
- 1 Jul 2017 (actual)
- First posted
- 31 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| DBS Patients Group | Experimental | Device: Body Motion Evaluation DARIBody Motion Evaluation DARI |
| Control Group | Active comparator | Device: Body Motion Evaluation DARIBody Motion Evaluation DARI |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Body Motion Evaluation DARIDynamic Athletic Research Institute (DARI) Software to evaluate motion tridimensionally with a camera system and without the use of body sensors. | Device | Control Group, DBS Patients Group |
Primary outcome
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)
Time frame: 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)
Time frame: 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.
Trunk Rotation, Trunk Flexion, Trunk Extension
Time frame: 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
Time frame: 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.
Cadence
Time frame: 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
Time frame: 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
Time frame: 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.
14 secondary outcomes
Speech
Time frame: 1 day: Test is done once with DBS in Off state.
Facial Expression
Time frame: 1 day: Test is done once with DBS in Off state.
Tremor at Rest
Time frame: 1 day: Test is done once with DBS in Off state.
Action or Postural Tremor of Hands
Time frame: 1 day: Test is done once with DBS in Off state.
Rigidity
Time frame: 1 day: Test is done once with DBS in Off state.
Finger Taps
Time frame: 1 day: Test is done once with DBS in Off state.
Hand Movements
Time frame: 1 day: Test is done once with DBS in Off state.
Rapid Alternating Movements of Hands
Time frame: 1 day: Test is done once with DBS in Off state.
Leg Agility
Time frame: 1 day: Test is done once with DBS in Off state.
Arising from Chair
Time frame: 1 day: Test is done once with DBS in Off state.
Posture
Time frame: 1 day: Test is done once with DBS in Off state.
Gait
Time frame: 1 day: Test is done once with DBS in Off state.
Postural Stability
Time frame: 1 day: Test is done once with DBS in Off state.
Body Bradykinesia and Hypokinesia
Time frame: 1 day: Test is done once with DBS in Off state.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2018.
- Background: PubMed 24595273Ceseracciu 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.
- Background: PubMed 25570653Rocha 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.
- BackgroundFry 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.
- BackgroundMoodie P. Validation : Reviewing 3D Motion Capture Technology Types and What the Gold Standard Should Be for Human Movement . Lenexa, Kansas
- BackgroundRosengarden 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.
- BackgroundWassom 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.
- BackgroundMündermann 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: PubMed 22074315Chen 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.
- Background: PubMed 27871019Perrott 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.
- Background: PubMed 24560691Galna 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.
- Background: PubMed 24375990Bovonsunthonchai 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.
- Background: PubMed 15502989Ferrarin 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hector R Martinez, MD, PhD principal investigator
Hospital Zambrano Hellion
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Body Motion Evaluation DARI in people with Parkinson Disease, run by Hospital Zambrano Hellion at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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) (time frame: 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.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03607721, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2018.