To develop well-described protocols for three tasks, i.e. a grasping task based on movement imagery, a button-press task, and a somatosensory finger mapping task, to be used in a larger ensuing clinical study by stroke patients in the 7T-MRI scanner…
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
a) Motor performance level (FM, ARAT, ABILHAND);
b) Hand motor performance and brain activation patterns during task
performance (fMRI);
c) Reaction time / movement time (button-press task);
d) Grip force
e) Somatosensory hand performance (fMRI);
f) T1-weighted anatomical scans and resting state scans (fMRI).
Secondary outcome
n.a.
Background summary
Most arm-hand rehabilitation approaches for stroke patients have been evaluated
in patients with residual motor function. Recently, dynamic hand-extension
orthoses have become available that unlock new training regimes for
low-functioning stroke patients. We aim to investigate the brain mechanisms
underlying the effects of orthosis-supported rehabilitation training to help
optimise and fine-tune treatment regimen for low-functioning stroke patients,
for whom, until now, treatment options are very limited. However, before
em-barking on such large scale clinical study, the necessary test protocols
that can also be used in an MRI scanner must first be developed and fine-tuned.
This is the aim of this pilot study.
Study objective
To develop well-described protocols for three tasks, i.e. a grasping task based
on movement imagery, a button-press task, and a somatosensory finger mapping
task, to be used in a larger ensuing clinical study by stroke patients in the
7T-MRI scanner at Scannexus / Maastricht university in Maastricht. Initial
brain imaging data associated with hand movement in orthosis-assisted and
non-orthosis-assisted conditions will be collected in three healthy subjects
and two patients with a severe hemiparesis (UAT 0-1) due to a stroke.
Furthermore, the two patients will be asked to use the hand orthosis at least *
hour per day over a period of six weeks, before and after which MRI data and
arm-hand motor performance data will be collected.
Study design
This pilot study is an observational study.
Study burden and risks
The participants in this pilot study will, themselves, have no direct benefit
from their participation. This pilot study will yield a) well-described
protocols regarding tasks to be performed in a 7T-MRI scanner, and b) initial
brain imaging data associated with hand movement in orthosis-assisted and
non-orthosis-assisted conditions. These data will also be used to estimate
group sizes in an ensuing larger clinical study. No risks are associated with
participation in this study. In this study, no medical product is used. The
SaeboGlove hand orthosis, a non-investigational product, poses no harm to the
subjects. The 7T-MRI measurements pose no harm to the participants.
Zandbergsweg 111
Hoensbroek 6432 CC
NL
Zandbergsweg 111
Hoensbroek 6432 CC
NL
Listed location countries
Age
Inclusion criteria
Stroke patients:
• Chronic unilateral supratentorial stroke;
• Post-stroke time > 12 months;
• Age >= 18 years;
• Severely impaired arm-hand function (AHF): Utrechtse Arm-hand Test (UAT) score 0-1;
• Ability to comprehend the test and measurement instructions (in Dutch).;Healthy persons:
- age >=18 years
- no history of stroke
- no impaired arm-hand function
- able to comprehend the test and measurement instructions in Dutch.
Exclusion criteria
CVA patienten:
• Severe cognitive impairments;
• Spasticity in the affected arm-hand: Modified Ashworth Scale (MAS) score >=2;
• Severe additional orthopaedic, rheumatoid, neurologic impairments of the body that may *further impede arm-hand task execution;
• No informed consent. ;• MRI contra-indications: epilepsy, claustrophobia, medication, metal parts in the body (metal plates or screws, clips on blood vessels, braces, metal wire behind teeth, prostheses, piercings, tattoos (including permanent makeup), artificial cardiac valve, anticonception spiral, metal splinters, pacemaker, insulin pump, other electronic devices)
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 | NL55631.015.15 |