NCT06544824

Brief Summary

The purpose of this study was to assess the Openpose reliability to measure kinematics and spatiotemporal gait parameters and to evaluate the minimum technical requirements. This analysis used video and optoelectronic motion capture simultaneously recorded. We assessed more of 20 subject with different motor gait impairments

Trial Health

75
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
5mo left

Started May 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Progress84%
May 2024Sep 2026

Study Start

First participant enrolled

May 15, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 5, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 9, 2024

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 24, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 24, 2026

Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

2.4 years

First QC Date

August 5, 2024

Last Update Submit

February 25, 2026

Conditions

Keywords

KinematicMarkerlessOpenPose

Outcome Measures

Primary Outcomes (3)

  • Absolute Error

    Absolute errors were calculated for the kinematics parameters and for each spatiotemporal variable by taking the absolute value after subtracting the values obtained using pose estimation methods from the value measured using markerbased motion capture

    Through study completion, an average of 1 year

  • intraclass correlation coefficients

    To confirm whether the data obtained by OpenPose agreed with the data from the optoelectronic system, investigators calculated the ICCs (two-way mixed effects model, absolute agreement, average measurements) between the spatiotemporal and kinematic data from both systems. The ICC values were interpreted as follows: poor agreement for ICC \< 0.5, moderate agreement for values between 0.5 and 0.75, good agreement for values between 0.75 and 0.9, and excellent agreement for values greater than 0.90.

    Through study completion, an average of 1 year

  • cross-correlation coefficients

    The cross-correlation coefficients (CCC) between both systems were used to evaluate the similarity of angles during the gait cycle. The CCC values were interpreted as follows: weak or no coupling for values between -0.3 and 0.3, moderate coupling for values between 0.3 and 0.7 or -0.7 and -0.3, and strong coupling for values greater than 0.7 or less than -0.7.

    Through study completion, an average of 1 year

Study Arms (5)

Healthy subjects

This group includes healthy subjects over 4 years of age; with the ability to walk independently without walking aids and/or orthoses.

Other: Measure gait spatiotemporal parameters and kinematics from optoelectronic systemOther: Measure gait spatiotemporal parameters and kinematics from markerless system

Subjects with a diagnosis of cerebral palsy and right hemiplegia

This group includes subjects with a diagnosis of cerebral palsy and right hemiplegia over 4 years of age; with the ability to walk independently without walking aids and/or orthoses.

Other: Measure gait spatiotemporal parameters and kinematics from optoelectronic systemOther: Measure gait spatiotemporal parameters and kinematics from markerless system

Subjects with a diagnosis of cerebral palsy and left hemiplegia

This group includes subjects with a diagnosis of cerebral palsy and left hemiplegia over 4 years of age; with the ability to walk independently without walking aids and/or orthoses.

Other: Measure gait spatiotemporal parameters and kinematics from optoelectronic systemOther: Measure gait spatiotemporal parameters and kinematics from markerless system

Subjects with a diagnosis of spastic paraparesis

TThis group includes subjects with a diagnosis of spastic paraparesis over 4 years of age; with the ability to walk independently without walking aids and/or orthoses.

Other: Measure gait spatiotemporal parameters and kinematics from optoelectronic systemOther: Measure gait spatiotemporal parameters and kinematics from markerless system

healthy children mimic gesture

This group includes a sample of healthy subjects who mimic the chimney tip typical of some diseases such as cerebral palsy and autism.

Other: Measure gait spatiotemporal parameters and kinematics from markerless systemOther: Quantify tip toe step during gait from kinematic

Interventions

The kinematic features calculated are used to identify and count the number of tip toe steps during gait or standing

healthy children mimic gesture

The raw data acquired from motion capture system were processed with Smart Analyzer software (BTS Bioengineering, Milano, Italy). First, the 3D data were filtered and interpolated in case of missing data for short time. Then spatial-temporal parameters (cycle duration, cadence, gait speed, stance phase, swing phase, double-support phase, stride length and step width) and conventional kinematic parameters of traditional Davis marker-set protocols were computed.

Healthy subjectsSubjects with a diagnosis of cerebral palsy and left hemiplegiaSubjects with a diagnosis of cerebral palsy and right hemiplegiaSubjects with a diagnosis of spastic paraparesis

The two videos were elaborated using OpenPose that returns a set of 25 2D keypoints coordinates for body pose estimation for each video. Key-points were located in relevant body landmarks and it were used to determine the 2D Cartesian coordinates on the sagittal plane and on the frontal plane. The data calculated with routines were filtered and interpolated in case of missing data. With respect to kinematic parameters, the segment and joint angles were measured from the estimated feature points of each joint. Spatiotemporal gait parameters were calculated using successive heel strike and toe-off events.

Healthy subjectsSubjects with a diagnosis of cerebral palsy and left hemiplegiaSubjects with a diagnosis of cerebral palsy and right hemiplegiaSubjects with a diagnosis of spastic paraparesishealthy children mimic gesture

Eligibility Criteria

Age4 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

This study includes subjects who previously underwent a functional motor assessment using the SMART DX 100 system at the IRCCS Eugenio Medea Institute. The sample comprises both healthy individuals and those with walking difficulties, all aged over 4 years.

You may qualify if:

  • Age over 4 years;
  • Ability to walk independently without walking aids and/or orthoses.

You may not qualify if:

  • Inability to walk independently and safely for short distances without walking aids and/or orthoses.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS E. Medea

Bosisio Parini, Italy, 22037, Italy

Location

MeSH Terms

Conditions

Motor Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Giuseppe Andreoni

    IRCCS E.Medea

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2024

First Posted

August 9, 2024

Study Start

May 15, 2024

Primary Completion (Estimated)

September 24, 2026

Study Completion (Estimated)

September 24, 2026

Last Updated

February 27, 2026

Record last verified: 2026-02

Locations