Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03278535 |
| Other study ID # |
NL61229.068.17 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 4, 2017 |
| Est. completion date |
June 3, 2021 |
Study information
| Verified date |
July 2021 |
| Source |
Maastricht University Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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. 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.
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.
