EXPLICIT aims tot obtain better functional outcome by early intensive rehabilitation. Next to clinical tests to measure improvement in function, neuroplasticity is assessed by fMRI, TMS and haptic robots. The combination of clinical outcome measures…
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Action Research Arm Test
focusing of cortical activity on the original physiological areas
bending of the trunk during the standard reaching task
velocity induced gain of the peripheral spinal reflex chain and reflex
modulation
Secondary outcome
Ashworth Score
Wolf Motor Function Test
Frenchay Arm Test
Motricity index
Brunnstrom Fugl Meyer arm/hand test
Nine Hole Peg Test
Erasmus MC Modification of the (revised) Nottingham Sensory Assessment
Stroke Impact Scale version 3.0
Nottingham Extended ADL
Motor Activity Log
O-Letter Cancellation Test
Barthel Index
Background summary
Prospective cohort studies show that about 80% of all stroke survivors have an
upper limb paresis immediately after stroke. Only one third of all stroke
patients will regain some dexterity, whereas well-researched evidence based
therapies for an effective treatment of the upper limb are lacking.
However, the main claim of the literature is that functional recovery of the
upper paretic limb is mainly defined within the first month post stroke and
that rehabilitation services should be applied preferably within this time
window of recovery. Furthermore, it is known that exercise-related
interventions are most effective when they are applied intensively in a
task-oriented way.
Study objective
EXPLICIT aims tot obtain better functional outcome by early intensive
rehabilitation.
Next to clinical tests to measure improvement in function, neuroplasticity is
assessed by fMRI, TMS and haptic robots. The combination of clinical outcome
measures and neuro-imaging will serve as a template for understanding basic
mechanisms of functional recovery after stroke.
EXPLICIT will provide an answer to the key question whether therapy induced
improvements are due to either a reduction of basic motor impairment by neural
repair or the use of behavioral compensation strategies.
Study design
2 randomized controled trials: 1 each for CIMT and EMG-neuromuscular
stimulation compared to conventional therapy.
Intervention
Constrained Induced Movement Therapy
or
EMG-triggered Neuromuscular Stimulation
or
Conventional therapy
Study burden and risks
There are very little risks associated with participation, as none of the
interventions or clinical measurements are invasive.
The proposed therapies have little to none known side-effects.
The safety standards for EEG are strictly followed.
The burden on the patients time will be 1,2 to 2,4 hours per week, depending on
the trial they will be allocated to.
Postbus 9600
2300 RC Leiden
NL
Postbus 9600
2300 RC Leiden
NL
Listed location countries
Age
Inclusion criteria
first-ever ischemic CVA, mono-or hemiparesis as defined by NIHSS, age between 18-80 year, able to communicate, able to sit without support, motivated to participate in an intensive rehabilitation programme for 3 weeks.
Exclusion criteria
treatment with rTPA, pacemaker or other metallic implants, previous existing orthopedic limitations of upper limb that would affect the results, botuline-toxine injections or medication that may influence upper limb function in past 3 months.
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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 | NL21396.058.08 |