1. Evaluate the relation between pretreatment muscle weaknesses, spasticity, abnormal synergies, and changes in viscoelastic joint properties on the one hand, and changes in upper extremity spasticity following treatment on the other hand in…
ID
Source
Brief title
Condition
- Neurological disorders congenital
- Central nervous system vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Relation between pre-treatment muscle weakness, spasticity, abnormal
synergies, and changes in viscoelastic joint properties and treatment outcome
quantified by change spasticity with a multivariable regression analysis,
correcting for several patient characteristics.
2. Responsiveness to treatment, quantified as the standardized mean difference,
of muscle weakness, spasticity, synergy, and viscoelasticity of the elbow
measured with the SEP.
Secondary outcome
N.A.
Background summary
Impaired upper extremity motor function is a common problem in patients who
suffer an upper motor neuron lesion (e.g., a stroke or cerebral palsy (CP)),
which has a major impact on their quality of life. Clinical signs of impaired
upper extremity function include muscle weaknesses, spasticity, abnormal
synergies, and changes in viscoelastic joint properties. Current clinical
assessments to study these signs include the Modified Ashworth scale, Tardieu
scale, Brunnstrom Fugl-Meyer scale, and Test of Arm Selective Control. During a
previous project (NL64660.078.18), we developed a reliable and valid
neuromechanical assessment protocol to quantify the elbow's muscle weakness,
spasticity, synergy, and viscoelasticity using a single robotic device, the
Shoulder Elbow Perturbator (SEP). As a next step, we want to investigate if the
outcome SEP scores obtained at baseline relate to the effect of
non-pharmacological, pharmacological, and surgical treatment options for upper
extremity spasticity in patients with upper motor neuron lesions. In addition,
we wish to investigate the responsiveness to clinical change of the
neuromechanical assessment outcome measures.
Study objective
1. Evaluate the relation between pretreatment muscle weaknesses, spasticity,
abnormal synergies, and changes in viscoelastic joint properties on the one
hand, and changes in upper extremity spasticity following treatment on the
other hand in patients with upper motor neuron lesions electing to undergo
treatment for upper extremity spasticity.
2. Investigate the responsiveness to treatment of the scores (muscle weakness,
spasticity, synergy, and viscoelasticity of the elbow), measured with the SEP.
Study design
Longitudinal observational study. We will extend the routine outcome measures
performed during the spasticity outpatient clinic in Rijndam Rehabilitation,
ErasmusMC or Amsterdam UMC (locatie VUmc) with additional measurements with the
SEP. Patients are currently routinely measured before a treatment decision is
made as part of clinical decision-making. Measurements will be performed before
treatment and 4-6 weeks after treatment.
Study burden and risks
The SEP is a non-invasive robotic device developed by Hankamp (Enschede, the
Netherlands) that imposes forces and displacements to the participants'
forearm. The device has several safety measures, in hard- and software, that
are explained in the IMDD file. The neuromechanical assessment protocol using
the SEP takes no longer than 45 minutes and has been previously developed as
part of protocol number NL64660.078.18. During the study, there will be no
direct benefits for the participants. However, the results of the current
project can presumably facilitate treatment decision making in the long term
for these target populations.
Dr.Molewaterplein 40
Rotterdam 3015GD
NL
Dr.Molewaterplein 40
Rotterdam 3015GD
NL
Listed location countries
Age
Inclusion criteria
- Visiting the outpatient clinic in Rijndam Rehabilitation Center, Erasmus MC,
or Amsterdam UMC (location VUmc) to seek treatment of spasticity of the upper
extremity.
- >=18 years;
- Minimal passive range of motion (PROM) in shoulder joint: 0-80° abduction,
0-45° anterior flexion.
- At least some volitional control of elbow flexion and extension;
- Having given written informed consent prior to undertaking any study-related
procedures.
Exclusion criteria
- Inability to understand instructions (for example due to intellectual
impairment);
- History of pre-existing neuromusculoskeletal disorders that would influence
the upper extremity function (e.g., presence of a prosthetics shoulder, other
neurological condition which might affect upper extremity function,
surgery/specific treatment <= 6 months);
- Damaged skin of the arm that interferes with the measurement set-up and/or
has negative influence for the participants;
- Contractures present at the upper limb that limit possibility to be fitted in
the SEP.
Design
Recruitment
Medical products/devices used
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 | NL80419.078.22 |