The primary objectives of this study are (a) to evaluate reliability and precision of an instrumented spasticity assessment device (ISA) in children with cerebral palsy and adults with spastic paresis (MS and stroke patients) and (b) to validate ISA…
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Brief title
Condition
- Muscle disorders
- Neuromuscular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Five muscle groups of the lower extremities will be tested with ISA: 1)
gastrocnemius; 2) soleus; 3) hamstrings; 4) rectus femoris; 5) hip adductors .
In addition, two muscle groups of the upper extremities will be tested with
ISA: 6) elbow flexors; 7) wrist flexors. Patient positioning and movement
direction of slow and fast passive muscle stretch will be based on accepted
clinical protocols.
In adults, all muscle groups will be tested. The children will be divided in 2
groups (upper and lower extremity testing each maximal two joints) to limit the
time of the assessment.
Primary outcome parameters measured by ISA are work [J] (area under the
power-time curve) and muscle activity (root mean square (RMS) EMG [uV]) for
both slow and fast stretch, the determine the non-neura; and neural
contribution to hyper-resistance.
To test the intra- and inter-rater reliability and measurement precision,
intraclass correlation coefficient (ICC), standard error of measurement (SEM)
and smallest detectable difference (SDD) will be calculated for each of the
outcome parameters.
To test validity, the non-neural and neural outcome parameters will be
correlated to the SPAT-scores (0-4 for catch), muscle tone (-1,0,1) and
Ashworth scale (0-4).
Secondary outcome
Secondary outcome measures are maximal velocity of performance (Vmax [deg/s]),
range of motion [deg], and stiffness [Nm/deg] for slow stretches to determine
the non-neural contribution. To determine the neural contributions in the fast
stretch secondary outcome measures are: maximal velocity of performance (Vmax
[deg/s]), joint angle of catch [deg], angle of EMG threshold [deg], and
intensity of catch (power [W]; torque times angular velocity).
Further secondary outcome parameters are the usability of the instrument
(including hard- and software parts) evaluated by a modified version of the
System Usability Scale (SUS) and the Quebec User Evaluation of Satisfaction
with assistive Technology (QUEST), and the patient-friendliness, evaluated by a
modified version of the Orthotics and Prosthetics Users* Survey Satisfaction
with Devices and Services (OPUS-SDS) and the QUEST.
Background summary
Spasticity is a clinical phenomenon that is frequently present in neurological
diseases, such as cerebral palsy (CP), multiple sclerosis (MS) and stroke. It
is defined as a velocity dependent stretch hyperreflexia and is one of the
contributors to hyper-resistance felt during clinical examination (i.e. passive
slow and fast stretch of a muscle).
Several physical examination tests have been developed to assess spasticity in
clinical practice, using passive muscle stretches at one or more velocities and
determining the angle of catch, defined as sudden resistance in the range of
motion due to fast stretch. However, in these tests it is difficult to
discriminate spasticity from other causes of hyper-resistance that is felt
during the physical examination. Furthermore, standardisation, quantification
and objectivity is lacking in these tests.
Therefore, we developed a measurement instrument for precise quantification of
hyper-resistance and its underlying components (non-neural and neural) in daily
clinical practice, based on internationally-accepted clinical protocols: the
ISA-device (which stands for: instrumented spasticity assessment), measuring
joint angle, angular velocity, muscle activity (electromyography (EMG)) and
applied torque.
Prior to application, the newly developed measurement instrument needs to be
tested for its clinometric properties, such as intra- and inter-rater
reliability, measurement precision and validity. Furthermore, the usability for
clinicians/examiners as well as patient friendliness need to be tested.
Study objective
The primary objectives of this study are
(a) to evaluate reliability and precision of an instrumented spasticity
assessment device (ISA) in children with cerebral palsy and adults with spastic
paresis (MS and stroke patients) and
(b) to validate ISA in children with cerebral palsy and adults with spastic
paresis by comparing this (concurrent validity) to the current clinical
standard (Spasticity test (SPAT), muscle tone and Ashworth scale (only in
adults)).
The secondary objectives are
(c) to evaluate usability of this instrument in daily clinical practice for the
performing clinicians/examiners and
(d) patient friendliness of ISA.
Study design
Observational study with a intra- and inter-rater design, including 2 examiners
Study burden and risks
The burden and risks for the participants of this study are minimal.
ISA may optimize the clinical decision-making of spasticity treatment in
relation to the aetiology, such as the dose-effect of spasticity reducing
medication. The subjects however will not have a direct benefit by
participating in the study since first the clinometric properties of the
instrument need to be evaluated and no intervention will yet be applied based
on outcome of the ISA.
The ISA device is specifically designed for clinical application in children
and also applicable for adults. Former research with spasticity tests and with
a previous prototype with children showed no risks.
The measurements are non-invasive and passive. The patient will be instructed
to completely relax.
During the tests, little fatigue, uncomfortable feeling and/or pain could
occur, however due to the nature of the tests (passive) and sufficient resting
periods between the tests the chance this will happen is limited.
The sensors and materials on the skin exist of skin-friendly material to avoid
any skin irritation.
After the measurement, a temporary uncomfortable feeling or pain might be
experienced in the muscle due to the muscle stretch. However, this will soon
disappear and does not cause any damage.
Patients will also be made aware that they are free to withdraw from the study
at any time without giving a reason and with no further consequences.
Boelelaan 1118
Amsterdam 1081 HZ
NL
Boelelaan 1118
Amsterdam 1081 HZ
NL
Listed location countries
Age
Inclusion criteria
Clinically established spasticity
- Children: GMFCS I-IV
- Age: 6-18y for the children
- Age: 18-70y for the adults
- Able to participate in the experiment for 1.5 hours.
Exclusion criteria
- unable to follow instruction
- patients who are already included in any other experimental research study
- Concomitant orthopedic disorders such as rheumatoid arthritis, osteoarthritis
- Concomitant neurological disorders
- Baclofen pump
- Change of (spasmolytic) medication in the past 4 weeks
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL54698.029.15 |