Primary objective of this study is to assess the reliability, validity, and diagnostic value of the neuromechanical parameters of joint impedance estimated by nonlinear SIPE technology in patients with a spastic paresis.
ID
Source
Brief title
Condition
- Muscle disorders
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Joint neuromechanical parameters, i.e. viscosity, stiffness, reflex torque.
Secondary outcome
Range of Motion (RoM) of ankle and wrist joint, Ashworth score, Angle of Catch,
VAS (Visual Analogue Scale) pain score, VAS satisfaction, GAS (Goal Attainment
Scaling) score, Rivermead Mobility Index (RMI), standard gait parameters.
Background summary
Therapy for spastic paresis in patients with brain damageis focused on either
neural or non-neural causes of increased joint impedance, or both. The clinical
community is in great need of quantitative and valid assessment of
neuromechanical parameters, i.e. the quantitative description of the neural and
non-neural contributors to joint impedance to guide therapy selection.
Nonlinear SIPE techniques allow for capturing the neuromechanical system during
functional movement, i.e. large angular displacements and joint torques. SIPE
is based on haptic robotic manipulators to impose displacements or torques on
joints during simulated functional movements.
Study objective
Primary objective of this study is to assess the reliability, validity, and
diagnostic value of the neuromechanical parameters of joint impedance estimated
by nonlinear SIPE technology in patients with a spastic paresis.
Study design
Observational cohort study. Initial phase (reliability): 1) test- retest and
inter-examiner reliability. Potential phase (validity): 2) comparison of stroke
patients to healthy controls; 3) comparison of neuromechanical parameters to
current clinical tests; 4) and 5) comparison of single joint approach to gait
characteristics and neuromechanical parameters assessed during gait; 6)
comparison of neuromechanical parameters to clinical phenotype expressed by a
gross motor function assessment scale. Quantitative phase (pre-post
comparison): 7) sensitivity of neuromechanical parameters to interventions,
i.e. botulinum toxin and splinting; 8) understanding of underlying
pathophysiological mechanisms. Diagnostic phase (predictive value): 9)
assessment of the predictive value of SIPE
Study burden and risks
The ROBIN protocol will align with current clinical practice, i.e. will not
interfere with clinical decision making. ROBIN will add extra measurements,
i.e. assessment of impedance around the ankle- or wrist joint using a single
axis robot manipulator and assessment of joint impedance around the ankle joint
using short, fast treadmill perturbations during regular gait analysis for a
selection of patients. Measurements are performed during regular visits to the
outpatient clinic. No extra visits of the patients are required, except during
the initial phase when reliability is assessed for n=15 stroke subjects and
n=15 control subjects. Measurements are non-invasive and bear minimal risks.
During a short time, active participation of patients and subjects is required.
Measurement time per session does not exceed 20 minutes for the single axis
robot manipulator and 60 minutes for the treadmill. Maximal number of sessions
per subject/patients is four.
Albinusdreef 2
Leiden 2300 RC
NL
Albinusdreef 2
Leiden 2300 RC
NL
Listed location countries
Age
Inclusion criteria
Adult with spastic paresis.
Improper joint resistance, eligible for intervention. The indication for treatment will be made independently of the ROBIN project.
Written informed consent for the robot manipulator measurements/treadmill
Exclusion criteria
Additional neurological diseases and/or orthopedic problems causing improper joint resistance and/or interfering with neuromechanical characteristics.
Subject unable to comply with the protocol, i.e. general fitness and cognitive/communicative inability to understand and participate in the measurements.
For treadmill, inability to walk without support
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 | NL40830.058.12 |