Modelling human neuromuscular responses to electro-mechanical stimuli after neurological injuries

Recruiting

Conditions: incomplete spinal cord injury
stroke
10029317

Registration Number: NL-OMON49185

Lead Sponsor: niversiteit Twente

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 75

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
• age between 19 and 75,
• legal capacity to give the consent at his/her own will;

for the stroke individuals:
• hemiparesis of the lower limb at chronic stage;

for the SCI individuals:
• chronic stage: time since SCI > 12 months,
• clear walking impairment but able to walk independently (with support), i.e.
Walking Index for
Spinal Cord Injury (WISCI) > 1 and spinal cord independence measure (SCIM) > 30,
• Motor incomplete spinal cord injury (ASIA impairment scale: C or D),
• Injury situated superior to the T9 vertebra.

Exclusion Criteria

Individuals fulfilling one of the following criteria will be excluded:
• neuromuscular disease,
• pregnancy,
• addictive or previous addictive behaviour defined as the abuse of cannabis,
opioids or other drugs,
• carrier of infectious diseases,
• degenerative mental impairment, e.g. dementia,
• inability to cooperate, e.g. due to cognitive deficits (in understanding
instructions) or a level of motor impairment that does not permit execution of
the intended tasks,
• subjects suffering from known cardiac conditions (e.g., pacemakers,
arrhythmias, and cardiac conduction disturbances) or peripheral neuropathy.
• skin sensitivity or allergies as these are typical contraindications for the
application of surface EMG electrodes via adhesive elements and conductive
gels.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome of this study are models capable of estimating the<br /><br>following neuro-mechanical parameters: joint kinematics, human-machine<br /><br>interaction forces, amplitude of mechanically-induced reflexes, and motor<br /><br>neuron parameters (e.g. discharge rate, inter-spike intervals and coherence<br /><br>between spike trains). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>All the subjects will be asked to fill out a questionnaire that assesses<br /><br>physical and physiological factors that may be of relevance for the analysis.<br /><br>These characteristics are the following:<br /><br>• Sex<br /><br>• Age (years)<br /><br>• Weight (kg)<br /><br>• Height (m)<br /><br>• Leg length (m)<br /><br>• Use of sedatives and analgesics<br /><br>• Other neurological disorders than stroke/SCI<br /><br>• Chronic pain<br /><br>• History of depression<br /><br>• History of diagnosed cognitive deficit</p><br>