NCT05751408

Brief Summary

A standard clinical gait analysis consists of observing walking with video (2D) or advanced equipment (VICON 3D). This 3D method provides detailed information about the gait pattern, but is time-consuming in implementation and data analysis. There are commercial 3D systems on the market that are used in healthy individuals and in sports. These so-called Inertial Measurement Units (IMUs) may also be suitable for use in the clinic. In this research protocol, the aim is to test the usability of commercial sensors and technically compare them with standard clinical 3D gait analysis in adult patients with a neurological disorder.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
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

First Submitted

Initial submission to the registry

January 25, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

January 25, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 2, 2023

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

April 19, 2024

Status Verified

April 1, 2024

Enrollment Period

2.4 years

First QC Date

January 25, 2023

Last Update Submit

April 18, 2024

Conditions

Gait Analysis

Outcome Measures

Primary Outcomes (12)

  • Ankle angle assessed by Vicon

    Vicon 3D analysis will be used to assess ankle angles (in degrees) during walking. Angles will be defined from the moment the foot hits the ground (initial contact) until the foot hits the ground again (second initial contact)

    baseline

  • Ankle angle assessed by Vicon

    Vicon 3D analysis will be used to assess ankle angles (in degrees) during walking. Angles will be defined from the moment the foot hits the ground (initial contact) until the foot hits the ground again (second initial contact)

    1 year

  • Knee angle assessed by Vicon

    Vicon 3D analysis will be used to assess knee angles (in degrees) during walking. Angles will be defined from the moment the foot hits the ground (initial contact) until the foot hits the ground again (second initial contact)

    baseline

  • Knee angle assessed by Vicon

    Vicon 3D analysis will be used to assess knee angles (in degrees) during walking. Angles will be defined from the moment the foot hits the ground (initial contact) until the foot hits the ground again (second initial contact)

    1 year

  • Hip angle assessed by Vicon

    Vicon 3D analysis will be used to assess hip angles (in degrees) during walking. Angles will be defined from the moment the foot hits the ground (initial contact) until the foot hits the ground again (second initial contact)

    baseline

  • Hip angle assessed by Vicon

    Vicon 3D analysis will be used to assess hip angles (in degrees) during walking. Angles will be defined from the moment the foot hits the ground (initial contact) until the foot hits the ground again (second initial contact)

    1 year

  • Ankle angle assessed by IMU sensors

    IMU sensors will be used to assess ankle angles (in degrees) during walking. Angles will be defined from the moment the foot hits the ground (initial contact) until the foot hits the ground again (second initial contact)

    baseline

  • Ankle angle assessed by IMU sensors

    IMU sensors will be used to assess ankle angles (in degrees) during walking. Angles will be defined from the moment the foot hits the ground (initial contact) until the foot hits the ground again (second initial contact)

    1 year

  • Knee angle assessed by IMU sensors

    IMU sensors will be used to assess knee angles (in degrees) during walking. Angles will be defined from the moment the foot hits the ground (initial contact) until the foot hits the ground again (second initial contact)

    baseline

  • Knee angle assessed by IMU sensors

    IMU sensors will be used to assess knee angles (in degrees) during walking. Angles will be defined from the moment the foot hits the ground (initial contact) until the foot hits the ground again (second initial contact)

    1 year

  • Hip angle assessed by IMU sensors

    IMU sensors will be used to assess knee angles (in degrees) during walking. Angles will be defined from the moment the foot hits the ground (initial contact) until the foot hits the ground again (second initial contact)

    baseline

  • Hip angle assessed by IMU sensors

    IMU sensors will be used to assess knee angles (in degrees) during walking. Angles will be defined from the moment the foot hits the ground (initial contact) until the foot hits the ground again (second initial contact)

    1 year

Secondary Outcomes (4)

  • Age

    at inclusion

  • Height

    at inclusion

  • Weight

    at inclusion

  • FAC-score

    at inclusion

Study Arms (2)

Stiff knee gait

Subjects referred to clinical 3D gait analysis because of a clinical question related to stiff knee gait

Procedure: gait analysis using 3D (Vicon) and IMU (Movella)

Foot surgery

Subjects referred to clinical 3D gait analysis because of a clinical question related to foot surgery

Procedure: gait analysis using 3D (Vicon) and IMU (Movella)

Interventions

gait analysis using 3D (Vicon) and IMU (Movella)PROCEDURE

Subjects are measured using Vicon 3D analysis, combined with IMU-sensors

Foot surgeryStiff knee gait

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects minimum 18 years of age, referred for clinical gait analysis at Roessingh, Centre for Rehabilitation in Enschede, the Netherlands with disorders affecting walking, including amongst others stroke, traumatic brain injury, MS, incomplete spinal cord injury, CP, Spina Bifida, neuromuscular diseases

You may qualify if:

  • Disorders affecting walking, including amongst others stroke, traumatic brain injury, MS, incomplete spinal cord injury, CP, Spina Bifida, neuromuscular diseases
  • age minimum 18 years
  • Viosca score minimum 2; meaning minimal independent walking ability indoors
  • increased fall risk or increased effort of walking because of: 1) decreased stability during stance; and/or 2) decreased foot clearance during swing; and/or 3) not able to walk on bare feet because of equinovarus; and/or 4) fatigue during walking because of compansatory strategies.

You may not qualify if:

  • subjects referred for clinical gait analysis because of problems other than stiff knee gait or foot surgery
  • severe deficits in communication, memory and understanding at such a level that it would affect instructions during the measurements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Roessingh Research and Development

Enschede, 7522AH, Netherlands

RECRUITING

Study Officials

  • C Nikamp, PhD

    Roessingh Research and Development

    PRINCIPAL INVESTIGATOR

Central Study Contacts

C Nikamp, PhD

CONTACT

+31880875777c.nikamp@rrd.nl

Study Design

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

Study Record Dates

First Submitted

January 25, 2023

First Posted

March 2, 2023

Study Start

January 25, 2023

Primary Completion

June 1, 2025

Study Completion

June 1, 2025

Last Updated

April 19, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)