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Reference Gait Data for Healthy Subjects

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ClinicalTrials.gov Identifier: NCT03278535
Recruitment Status : Recruiting
First Posted : September 11, 2017
Last Update Posted : September 11, 2017
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center

Brief Summary:
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. Seven age groups are composed existing of ten male and ten female. Taken into account that 10% of the volunteers (especially elderly) may drop out due to e.g. disability, a total of 155 subjects will be recruited to ensure that database will include 140 subjects. Inclusion criteria: ambulatory, ability to walk without aid for 30 minutes, age older than 18years 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.

Condition or disease Intervention/treatment
Healthy Subjects Healthy Volunteers Healthy Adults Diagnostic Test: CAREN-based gait analysis

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 155 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Reference Gait Data for Healthy Subjects: Caren-based Gait Analysis
Actual Study Start Date : July 4, 2017
Estimated Primary Completion Date : July 4, 2019
Estimated Study Completion Date : July 5, 2019

Group/Cohort Intervention/treatment
age group 18-29 years
CAREN-based gait analysis: 10 men and 10 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: 10 men and 10 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: 10 men and 10 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: 10 men and 10 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: 10 men and 10 women aged between 60-69years
Diagnostic Test: CAREN-based gait analysis
subjects only walk at CAREN at different speed

age group 70-79years
CAREN-based gait analysis: 10 men and 10 women aged between 70-79years
Diagnostic Test: CAREN-based gait analysis
subjects only walk at CAREN at different speed

age group 80+
CAREN-based gait analysis: 10 men and 10 women aged 80 years and older
Diagnostic Test: CAREN-based gait analysis
subjects only walk at CAREN at different speed




Primary Outcome Measures :
  1. CAREN-based kinematic gait parameters [ Time Frame: 4-7-2017 until 4-7-2019 ]
    Kinematics of the hip, knee and ankle measured during the gait cycle (e.g. stance phase knee flexion).

  2. CAREN-based kinetic gait parameters [ Time Frame: 4-7-2017 until 4-7-2019 ]
    Kinetics of the hip, knee and ankle measured during the gait cycle (e.g. flexion/extension moments of the hip)

  3. CAREN-based spatiotemporal gait parameters [ Time Frame: 4-7-2017 until 4-7-2019 ]
    e.g. walking speed, stride time, cadence, step width, step length.

  4. CAREN-based balance parameter [ Time Frame: 4-7-2017 until 4-7-2019 ]
    mediolateral and backward margins of stability (MoS)


Secondary Outcome Measures :
  1. anthropometric characteristic: body height [ Time Frame: 4-7-2017 until 5-7-2019 ]
    Body height (cm)

  2. anthropometric characteristic: body weight [ Time Frame: 4-7-2017 until 5-7-2019 ]
    Body weight (kg)

  3. anthropometric characteristic: leg length [ Time Frame: 4-7-2017 until 5-7-2019 ]
    Leg length (cm)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
The aim of the study is to create a reference database consisting of 140 healthy (70 men, 70 women), ranging from 18 years to > 80yrs. For each of the seven age categories (18-29yrs, 30-39yrs, 40-49yrs, 50-59yrs, 60-69yrs, 70-79yrs, > 80yrs), 10 men and 10 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 140 subjects will be included at the end. This results in a total of 155 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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03278535


Contacts
Contact: Rachel Senden, Dr 0433877146 rachel.senden@mumc.nl
Contact: Rik Marcellis, Dr 0433877146 rik.marcellis@mumc.nl

Locations
Netherlands
Maastricht UMC Recruiting
Maastricht, Limburg, Netherlands, 6229
Contact: AF Lenssen, Dr    0433875145    af.lenssen@mumc.nl   
Contact: G Roox, Dr    0433875145    george.roox@mumc.nl   
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
Principal Investigator: Rik Marcellis, Dr Maastricht UMC - dept. Fysiotherapy

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT03278535     History of Changes
Other Study ID Numbers: NL61229.068.17
First Posted: September 11, 2017    Key Record Dates
Last Update Posted: September 11, 2017
Last Verified: June 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No