Reference Gait Data for Healthy Subjects

September 3, 2021 updated by: Maastricht University Medical Center

Reference Gait Data for Healthy Subjects: Caren-based Gait Analysis

Three dimensional gait analysis is widely accepted as a general measure of functional ability among individuals as it is related to health, well-being and quality of life. To diagnose subtle changes/deviations in gait and to correctly interpret gait, a reference gait database of healthy subjects is required. Computer Assisted Rehabilitation Environment (Caren) is a new gait analysis system which combines the 3D motion captures system with a split belt force plate instrumented treadmill and a virtual reality environment. This system enables to analyses several successive steps, which is impossible in the standard overground laboratories. Until now, no reference gait database has been created using the Caren system. The aim of this descriptive study is to create a reference database of gait in healthy adults with varying subject characteristics using Caren. This study is a single center descriptive study to build a reference database on gait of healthy adults of different ages. Six age groups are composed existing of 20 males and 20 females. Taken into account that 10% of the volunteers (especially elderly) may drop out due to e.g. disability, a total of 264 subjects will be recruited to ensure that database will include 240 subjects. Inclusion criteria: ambulatory, ability to walk without aid for 30 minutes, age older than 18 years and willing to participate. Exclusion criteria: muscular skeletal, cardiopulmonary disorders or other diseases significantly influencing gait. Medical interventions, such as surgical treatment or botulinium toxin 6 months, which significantly influence gait. Subjects will walk at different walking speeds at Caren while gait is measured. Subjects always wear a safety harness to avoid falling. In addition adults wear standard shoes (gymnastic booties) provided by the lab to avoid shoes effects. All subjects undergo measurement of leg length, body length and body weight in order to retrieve anthropometric parameters. In addition a standard physical examination is performed to get information about a subjects' muscle strength, balance and articular mobility of the hip, knee and ankle. Gait kinematic, kinetic, spatio-temporal and balance parameters are measured.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Gait is one of the most important activity of daily life for humans. In clinical and research settings, gait performance is widely accepted as a general measure of functional ability among individuals. Computer Assisted Rehabilitation ENvironment (CAREN; Motek Medical, Amsterdam, The Netherlands) is a relatively novel system to analyze gait in a safe and accurate way. CAREN consists of an instrumented split-belt treadmill mounted onto a 6-degree-of-freedom motion platform in combination with a Virtual Environment projected on a 180° semi-cylindrical screen. Two force plates underneath each belt and 12 3D motion capture cameras (VICON system) allow an accurate analysis of gait which is expressed by kinematic, kinetic, spatiotemporal en dynamic balance parameters. Currently at the MUMC+, CAREN-based gait analysis is used for clinical purposes and is increasingly more applied to contribute in clinical diagnostics and decision-making and to evaluate interventions and rehabilitation programs. Besides, the CAREN system is applied in gait analysis laboratory settings as an alternative or an additive to over ground gait analysis. However, due to its novelty, size, high costs, and complexity, the CAREN system is not a widely accessible technology. Literature is limited and research is still in progress. From these experiences, it is known that CAREN is safe in use.

An individuals' walking pattern is variable and can change due to several factors such as advancing age. Furthermore gait is influenced by body characteristics such sex, body height and mass. Gait also changes as a result of health-related factors such as pain and diseases. Moreover gait can change through rehabilitation and training. This all suggests that human gait analysis is useful for clinical purposes, for example for diagnostics or to evaluate rehabilitation programs. However to apply human gait analysis in clinical practice, it is crucial to have insight into the normal walking pattern of individuals. A gait database of healthy subjects with varying subject characteristics (e.g. age) is required to ensures that gait is correctly interpreted. This database will give further insight in the dynamics of walking, clarifying the level and proportion in which gait is affected by subject characteristics and walking speed. This insight will improve the interpretation of gait, and thus contribute to improved clinical diagnostics and follow up capabilities. In addition the database will be relevant in clinical practice as it quickly puts into perspective gait of patients. Moreover it enables the detection of subtle changes in gait (e.g. after intervention).

Objective and hypothesis:

This research is a single center descriptive study to create a reference database of gait of healthy adults of different ages. Six age groups are composed (18-29yrs, 30-39yrs, 40-49yrs, 50-59yrs, 60-69yrs, >70yrs), existing of 20 males and 20 females.

This descriptive study aims to build a reference gait database for healthy subjects based on CAREN including kinematic, kinetic, spatio-temporal and balance parameters. Values for gait parameters of healthy adults will be created for varying age groups and sex. In addition, knowing the impact of walking speed on various gait parameters, gait parameters of healthy subjects will be clustered per walking speed, taking sex and age into account.

Primary Objective:

A descriptive study to collect a Caren-based reference database for healthy gait.

Secondary Objectives:

  • To investigate effects of subject characteristics such as age, sex and leg length on gait kinematic, kinetic, temporal-spatial and balance parameters.
  • To investigate the relation between walking speed and gait kinematic, kinetic, temporal-spatial and balance parameters.

Methods:

This is a single center descriptive study performed at the department Physiotherapy of the Maastricht University Medical Center (MUMC+) in which gait of healthy adult volunteers of varying ages is obtained by the new Computer Assisted Rehabilitation ENvironment (Caren) system. The collected data will be used to create a database for gait parameters of healthy subjects.

120 healthy men and 120 healthy women, equally divided over the six age groups (18-29j, 30-39j, 40-49j, 50-59j, 60-69j, >70j) are included.

The healthy adult volunteers will walk at different walking speeds at the Caren system.

First, the comfortable walking speed of the subject is determined using a ramp protocol. This includes that subject starts walking at 0.5m/s and that the speed is increased every second by 0.01m/s until the subject reached the comfortable walking speed. This is repeated 3 times. The average of these 3 walking speeds is used as comfortable walking speed. Afterward, the subject walks for 5 minutes at the fixed comfortable speed to get familiarized to the system. After familiarization, the measurement starts. The volunteers will walk at comfortable speed, at a slow speed (comfortable speed - 30%), a fast speed (comfortable speed + 30%) and at a slower speed (fixed at 0.5km/h). These four conditions are randomly applied to eliminate a possible effect of sequence of performed walking speed (and thus familiarization) on gait. Every measurement is proceeded by a 2 minute habituation period at that specific walking speed. Subjects will wear a safety harness to avoid falling. In addition adults wear standard shoes (gymnastic booties) provided by the lab to avoid shoes effects.

Gait kinematics (joint angles), kinetics (joint moments and power), spatio-temporal parameters (e.g. stride length) and dynamic balance parameters (e.g. margins of stability) will be determined. Values for gait parameters of healthy adults will be created and clustered for varying age groups, sex and walking speeds.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
264

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Limburg
      • Maastricht, Limburg, Netherlands, 6229
        • Maastricht UMC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The aim of the study is to create a reference database consisting of 240 healthy (120 men, 120 women), ranging from 18 years to > 70yrs. For each of the six age categories (18-29yrs, 30-39yrs, 40-49yrs, 50-59yrs, 60-69yrs, >70yrs), 20 men and 20 women will be included. Assuming that 10% of the volunteers (especially elderly) may drop out because subjects cannot complete the protocol due to fatigue, impaired condition, fear etc., an additional 10% will be recruited to ensure that 240 subjects will be included at the end. This results in a total of 264 subjects that will be recruited. When subjects do not want to continue participating in the study and want to stop the procedure, the subjects can stop at any time and withdraw without any reason.

Description

Inclusion Criteria:

  • Ambulatory
  • Ability to walk without aid for 30 minute
  • Willing to participate and able to provide informed consent.
  • 18 years or older

Exclusion Criteria:

  • Muscular skeletal, cardiopulmonary disorders or other diseases significantly influencing gait.
  • Medical interventions, such as surgical treatment or botulinium toxin 6 months, which significantly influence gait.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
age group 18-29 years
CAREN-based gait analysis: 20 men and 20 women aged between 18-29 years
Diagnostic test: CAREN-based gait analysis
subjects only walk at CAREN at different speed
age group 30-39years
CAREN-based gait analysis: 20 men and 20 women aged between 30-39years
Diagnostic test: CAREN-based gait analysis
subjects only walk at CAREN at different speed
age group 40-49years
CAREN-based gait analysis: 20 men and 20 women aged between 40-49years
Diagnostic test: CAREN-based gait analysis
subjects only walk at CAREN at different speed
age group 50-59years
CAREN-based gait analysis: 20 men and 20 women aged between 50-59years
Diagnostic test: CAREN-based gait analysis
subjects only walk at CAREN at different speed
age group 60-69years
CAREN-based gait analysis: 20 men and 20 women aged between 60-69years
Diagnostic test: CAREN-based gait analysis
subjects only walk at CAREN at different speed
age group 70+
CAREN-based gait analysis: 20 men and 20 women aged between 70 years and older
Diagnostic test: CAREN-based gait analysis
subjects only walk at CAREN at different speed

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
CAREN-based kinematic gait parameters
Time Frame: 4-7-2017 until 3-6-2021
Kinematics of the hip, knee and ankle measured during the gait cycle (e.g. stance phase knee flexion).
4-7-2017 until 3-6-2021
CAREN-based kinetic gait parameters
Time Frame: 4-7-2017 until 3-6-2021
Kinetics of the hip, knee and ankle measured during the gait cycle (e.g. flexion/extension moments of the hip)
4-7-2017 until 3-6-2021
CAREN-based spatiotemporal gait parameters
Time Frame: 4-7-2017 until 3-6-2021
e.g. walking speed, stride time, cadence, step width, step length.
4-7-2017 until 3-6-2021
CAREN-based balance parameter
Time Frame: 4-7-2017 until 3-6-2021
mediolateral and backward margins of stability (MoS)
4-7-2017 until 3-6-2021

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
anthropometric characteristic: body height
Time Frame: 4-7-2017 until 3-6-2021
Body height (cm)
4-7-2017 until 3-6-2021
anthropometric characteristic: body weight
Time Frame: 4-7-2017 until 3-6-2021
Body weight (kg)
4-7-2017 until 3-6-2021
anthropometric characteristic: leg length
Time Frame: 4-7-2017 until 3-6-2021
Leg length (cm)
4-7-2017 until 3-6-2021

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Maastricht University Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Rik Marcellis, Dr, Maastricht UMC - dept. Fysiotherapy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 4, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 3, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 3, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 11, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 7, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 11, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 5, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 3, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NL61229.068.17

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy Volunteers

Clinical Trials on CAREN-based gait analysis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings