To develop a feasible assessment protocol to quantify the impaired upper extremity function in terms of muscle weakness, spasticity, synergy and viscoelastic properties around the elbow.To evaluate the reliability (test-retest, measurement error)…
ID
Source
Brief title
Condition
- Neurological disorders congenital
- Central nervous system vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters are muscle weakness, spasticity, abnormal synergy and
changed viscoelastic properties of the upper extremity, as measured with the
Shoulder-Elbow Perturbation (SEP).
Secondary outcome
The secondary study parameters are spasticity and abnormal synergy as measured
with clinical assessment tools.
Spasticity:
In stroke patients and adults with CP: Tardieu scale.
Synergy:
In stroke patients: Brunnström Fugl-Meyer (BFM) of the upper extremity;
In adults with CP: Test of Arm Selective Control (TASC).
Background summary
Disability in upper extremity function, due to sensorimotor deficits and other
deficits, is a common problem for patients that suffered from a stroke and
adults with cerebral palsy (CP). This problem can lead to restricted mobility
of the upper extremity, resulting in an impact on the quality of life [1].
Clinical signs of impaired upper extremity function are muscle weaknesses due
to paresis or paralysis, abnormal reflex activity (spasticity), loss of
independent joint control (abnormal synergies) and changes in viscoelastic
properties (joint stiffness). Current clinical assessments to study these signs
include the Modified Ashworth scale and the Brunnstrom Fugl-Meyer scale.
However, such clinical assessments have limitations, such as a high observer
variability [2]. In order to improve treatment outcomes of upper extremity
function interventions, accurate diagnosis of the explanatory deficits is
needed. Previous studies already investigated assessment protocols to
distinguish some clinical signs/parameters with a neuromechanical model in
combination with a robot. To that end, a more comprehensive neuromechanical
assessment to distinguish all four clinical signs, might provide better
diagnosis. A robot device, combined with a scientific model, can presumably
identify and quantify the contribution of muscle weakness, abnormal reflex
activity, loss of independent joint control and changes in viscoelastic
properties to upper extremity impairment.
Study objective
To develop a feasible assessment protocol to quantify the impaired upper
extremity function in terms of muscle weakness, spasticity, synergy and
viscoelastic properties around the elbow.
To evaluate the reliability (test-retest, measurement error) and construct
validity of the impaired upper extremity function parameters in chronic stroke
patients and adults with CP.
Study design
Two cross-sectional exploratory studies will be performed at Erasmus MC and
Rijndam Rehabilitation Center, The Netherlands.
Study burden and risks
This study is a non-invasive diagnostic study. During the study there will be
no direct benefits for the participants. However, results of the current
project can presumably facilitate treatment evaluation, treatment efficiency
and treatment policy in the long-term for these target populations. In this
study, a robot-arm device (SEP) developed by Hankamp (Enschede, the
Netherlands) will be used. The SEP imposes a force on the forearm of the
participants and measures relevant outcome parameters, which will be analyzed
using neuromuscular models. The device has several safety measures that are
explained in the IMDD file. Study participants will receive a SEP assessment
that takes up to 60 minutes and next to clinical measurements (Tardieu scale
and BMF/TASC).
Measurements can be experienced intensively for the affected arm because the
SEP-assessment will take up to an hour. In total 6 assessments will be
measured: 3 active measurements with the SEP-device, 1 passive measurement with
the SEP device, 1 active clinical assessment, and 1 passive clinical
assessment. During an assessment, 1 minute rest will be given between each
repetition and 5 minutes between assessments.
Patients will come to the hospital on different occasions:
For the first objective, the participants will come ones to the Erasmus MC.
For the second objective, the participants will come twice to the Erasmus MC (±
2 hours per visit).
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
Listed location countries
Age
Inclusion criteria
- *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.;In addition, the following inclusion criteria apply for stroke patients:
- Patients need to have an unilateral upper extremity impairment;
- Chronic (> 6 months) patients.
In addition, the following inclusion criteria apply for adults with CP:
- Adults with CP need to have an upper extremity impairment;
- Spastic unilateral or spastic bilateral adults with CP.
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);
- Damage skin of the arm that interferes with the measurement set-up and/or has negative influence for the participants;
- Hemiplegic shoulder pain;
- Patients with fixed contractures in the upper extremity that hinder the experimental setup.
- Intellectual impairment, or psychiatric disorder that hinders understanding measurement instructions. ;In addition, the following exclusion criteria apply for adults with CP:
Adults with very severe motor disorders: a level V on the gross motor function classification system (GMFCS) and/or a level V on the manual ability classification system (MACS).
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 | NL64660.078.18 |