The primary goal of this study is to describe possible causes of gait asymmetry in patients with an endoprosthetic reconstruction of the knee joint due to a bone tumour. Therefore, the assumed gait asymmetry is first verified (part A). Subsequently…
ID
Source
Brief title
Condition
- Bone disorders (excl congenital and fractures)
- Skeletal neoplasms malignant and unspecified
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Measurements are performed in two gait labs. Part of this amendment is the
addition of a second gait lab.
Gait Laboratory 1 is the Technology in Motion (TIM) lab at the LUMC. We use the
interactive walkway. The interactive walkway makes it possible to record
movements without sensors.
Gait laboratory 2 is the movement lab for rehabilitation medicine at the LUMC.
The M-Gait treadmill, a treadmill with multiple calibrated camera setup and
bilateral continuous ground reaction force measurement, was introduced in 2022.
The participant first walks in lab 1 and then in lab 2.
Measurements
- Step time (s) during unperturbed comfortable walking for the affected leg and
the unaffected leg measured with the Interactive Walkway. Step time is the time
interval between initial contact of one leg to the consecutive initial contact
of the contralateral leg;
- Interlimb step time difference (s) to quantify for (a)symmetry;
- Patient reported outcome scores (PROM's) for pain, fear (kinesiophobia) and
health using a numeric rating scale (NRS) administered before gait analysis.
For measurements on the treadmill, the participant will be secured in a
CE-approved harness that is secured to the ceiling with ropes under dynamic
pretension. For measurements with the M-Gait the subjects will walk on the
treadmill for one-and-a-half minute twice: once with the mean walking velocity
measured earlier with the IWW, in order to maximize the comparability with data
obtained with the IWW, and once using self-paced mode, where the treadmill
speed is automatically adapted to the patients walking speed. For both
measurements, the patient will be able to get familiar with walking on the
treadmill for the first 30 seconds and only the last minute of walking will be
recorded and used for analysis.
Secondary outcome
- Toronto Extremity Salvage Score (TESS), lower extremity version: a validated
questionnaire to assess patient-reported physical outcome;
- Pedometer-assessed (health app, mobile phone) steps per day, if available, of
the last week for assessing the daily physical activity;
- Other walking data recorded in the TIM-lab can be used for possible sub
analyses: centre of body mass, gait speed, step width, step length, stride
time, turning time, stride length, cadence.
Background summary
The life expectancy for patients with bone tumours is increasing and therefore
long-term functioning has become more important. When bone tumours are located
around the knee, a custom-made tumour prosthesis of the knee joint is often
implanted after the tumour is resected. It is likely that patients use the
affected leg and the unaffected leg asymmetrically during walking due to e.g.
anatomical changes, neural damage, pain and fear. This leads to a less
efficient walking pattern. The relation of affected ambulance with these
underlying causes are not yet known, but essential for tailored therapy (e.g.
physical-, psychological-, rehabilitation therapy, pain management). We
hypothesize that patients after endoprosthetic reconstruction show asymmetrical
ambulance, resulting in a longer step time for the affected leg compared to the
unaffected leg. This asymmetry is assumed to relate to pain, fear and health
scores.
Study objective
The primary goal of this study is to describe possible causes of gait asymmetry
in patients with an endoprosthetic reconstruction of the knee joint due to a
bone tumour. Therefore, the assumed gait asymmetry is first verified (part A).
Subsequently, gait asymmetry is related to pain-, fear- and general health, as
possible causes (part B). Secondarily, gait asymmetry is related to functional
outcome measures in order to see whether gait asymmetry affects daily
functioning.
Study design
This study is an observational single-centre cross-sectional cohort study, that
takes place in two parts. Depending on the interim analysis after part A, we
will continue if sufficient asymmetry is observed. If gait is symmetrical, the
study will be terminated.
Study burden and risks
This visit will take approximately 30 minutes. Motion registration will be done
in a quick and patient-friendly manner. Movement data are obtained by multiple
Microsoft Kinect sensors that do not require markers to be attached to the body
of to the subjects' bodies. Subjects will not personally benefit from
participation in this study.
In such a movement analysis, however, a fall risk is equated with the risk of
falling during normal walking. On the treadmill, extra protection is provided
with a harness while running.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
Tumour resection and a reconstruction of the knee joint with a MUTARS® system
(Modular Universal Tumour and Revision System) in the LUMC during the previous
10 years (2008-2018) due to a primary bone tumour around the knee (distal femur
or proximal tibia); Tumour resection and reconstructive surgery is at least 1
year ago; One unaffected (healthy) leg; Normal or corrected to normal vision;
At least 18 years old at time of inclusion; Signed informed consent form.
Exclusion criteria
Major revision surgery (e.g. total replacement of the prosthesis with
reattaching muscles) in the last 1 year; Minor revision surgery (e.g.
replacement of a small part of the prosthesis without reattaching muscles) in
the last 3 months; Endoprosthetic failure; Comorbidities interfering with gait
function Inability to comply with the assessment in the TIM laboratory;
Inability to walk independently.
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
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In other registers
Register | ID |
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CCMO | NL69691.058.19 |