The main objective of this study is to create and validate subject-specific models of the human neuromuscular system capable of estimating neuro-mechanical activity in vivo in healthy, post-stroke and SCI individuals. In addition, we want to prove…
ID
Source
Brief title
Condition
- Neuromuscular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome of this study are models capable of estimating the
following neuro-mechanical parameters: joint kinematics, human-machine
interaction forces, amplitude of mechanically-induced reflexes, and motor
neuron parameters (e.g. discharge rate, inter-spike intervals and coherence
between spike trains).
Secondary outcome
All the subjects will be asked to fill out a questionnaire that assesses
physical and physiological factors that may be of relevance for the analysis.
These characteristics are the following:
• Sex
• Age (years)
• Weight (kg)
• Height (m)
• Leg length (m)
• Use of sedatives and analgesics
• Other neurological disorders than stroke/SCI
• Chronic pain
• History of depression
• History of diagnosed cognitive deficit
Background summary
Human movement emerges from the interplay between the nervous and
musculoskeletal systems. Despite knowledge of the mechanisms at the individual
systems there are major gaps in the understanding of their interplay. In this
study, both healthy and neurologically impaired populations are studied in
highly controlled and safe experiments. The data collected from these
experiments are used as a basis for creating detailed subject-specific
numerical models of the composite neuromuscular system for ankle exoskeleton
control and to validate them on healthy, stroke and spinal cord injury
participants. These models might shed light on how human movement is modulated
and how it is affected by neurological conditions. This knowledge can be used
to design rehabilitation strategies highly personalized to the patient.to
optimize recovery and thus improve their quality of life.
Study objective
The main objective of this study is to create and validate subject-specific
models of the human neuromuscular system capable of estimating neuro-mechanical
activity in vivo in healthy, post-stroke and SCI individuals. In addition, we
want to prove that these models can predict how neuro-mechanical activity is
altered by external devices including robotic dynamometers and ankle
exoskeletons both in healthy, post-stroke and SCI individuals.
Study design
This is a one-site observational study consisting of three phases.
Study burden and risks
The study does not create direct benefits for the subjects, as the protocol
just adds observational experiments on top of regular clinical care. The burden
is minimal and the risks negligible, as the protocol consists of standard tests
with a duration of less than three hours. In total, subjects will participate
in three phases. Similar tests have already been executed/approved multiple
times by the METC.
De Horst 2
Enschede 7522LW
NL
De Horst 2
Enschede 7522LW
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
• age between 16 and 85,
• legal capacity to give the consent at his/her own will;
for the stroke individuals:
• hemiparesis of the lower limb at chronic stage (> 3 months);
• impaired plantar flexion during walking
• MRC Grade 3 and above for the calf
• FAC score of 3 and above
• Ability to walk at least 6 minutes at their self-selected walking speed.
for the SCI individuals:
• chronic stage: time since SCI > 12 months,
• clear walking impairment but able to walk independently (without 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.
• Ability to walk at least 6 minutes at their walking speed.
Exclusion criteria
Individuals fulfilling one of the following criteria will be excluded: Motor
complete spinal cord injury (ASIA impairment scale: A or B),
• 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.
• Participating in an ongoing study
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 | NL73230.091.20 |