Primary Objectives: * To determine if NA patients have altered cerebral activity related to motor planning of their affected arm compared to healthy controls and compared to their non-affected arm.* To determine if specific rehabilitation focused on…
ID
Source
Brief title
Condition
- Peripheral neuropathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
For the cross-sectional comparison, as well as for the neuroimaging part of the
randomized controlled trial, the main parameters are changes/differences in the
magnitudes of mean functional MRI signal (BOLD activity) related to motor
imagery of the affected arm, quantifying changes in central motor control.
For the clinical part of the randomized controlled trial, the main parameter is
change in functional (dis)ability of the shoulder, arm and hand, measured with
the Shoulder Rating Questionnaire (SRQ), after a 17-week treatment period.
Secondary outcome
Secondary study parameters include:
Both for the cross-sectional comparisson and the randomized controlled trial :
Differences/changes in:
- behavioral performance (i.e. reaction times and error rates) on 2 motor
imagery tasks (which require participants to imagine making arm/hand movements,
assessing cognitive motor control)
- functional and structural organization of the brain (as assessed with MRI
neuroimaging techniques)
- reachable workspace, as measured with a standardized movementprotocol and
Kinect sensor
- scapular position and orientation when lifting the arm, as derrived from
3D-photography
- maximum force exerted with the serratus anterior (when reaching with elbow,
and with hand), endo- and exorotation of shoulder, key grip, and hand grip
-fatigue, as measured with the checklist individual strength - subscale fatigue
-quality of life, as measured with the short form 36
Only for the randomized controlled trial:
Differences/changes in:
-functional disability of the arm shoulder and hand as measured with the
Disability of Arm, Shoulder and Hand.
-pain, as measured with the McGill Pain Questionnaire
-self-efficacy for performing energy conservation strategies, as measured with
the Self-Efficacy for Performing Energy Conservation Strategies Assessment
-pain self-efficacy, as measured with the Pain Self-Efficacy Questionnaire
-participation, as measured with the Utrecht Scale for Evaluation of
Rehabilitation-Participation
-patients' activation with regard to their health and disease, as measured with
the Patient Activation Measure
-changes (pre- and post-experimental intervention) in occupational performance
and satisfaction with performance of the most important daily occupations
identified as a problem by the patient. This is assessed with the Canadian
Occupational Performance Measure.
Background summary
Neuralgic amyotrophy(NA) is a common (incidence 1:1000) peripheral nervous
system disorder caused by acute autoimmune inflammation of the brachial plexus.
Many NA patients develop abnormal motor control of the scapular region,
scapular dyskinesia, which persists even after peripheral nerve recovery. This
suggests that persistent scapular dyskinesia in NA may result from
(mal)adaptive changes in the cerebral motor system. Rehabilitation focused on
cognitive motor control can restore scapular dyskinesia, indicating that the
impaired motor control can be restored. This leads to the novel concept that
peripheral nerve damage may lead to central adaptations that are compensatory
in the acute phase, but lead to impaired motor control in the chronic phase. We
hypothesize that NA is associated with maladaptive cerebral motor control,
resulting in scapular dyskinesia. Rehabilitation focused on cognitive motor
control can reverse these cerebral changes and is more effective in improving
functional disability than usual care.
Study objective
Primary Objectives:
* To determine if NA patients have altered cerebral activity related to motor
planning of their affected arm compared to healthy controls and compared to
their non-affected arm.
* To determine if specific rehabilitation focused on cognitive motor control
can reverse the central changes in NA patients, and improves functional
disability in NA, as compared to usual care.
Secondary Objective(s):
* To determine if central changes in NA patients* cognitive networks can be
detected with functional MRI and structural MRI.
* To evaluate whether specific rehabilitation results in improvements in a wide
range of domains, including scapular dyskinesia and personal factors such as
fatigue, participation and quality of life.
* To assess lasting effects of treatment (17 weeks post treatment) on a variety
of factors, including functional ability, participation, quality of life,
personal factors and patient activation.
Study design
Exploratory cross-sectional comparison and open-label randomized controlled
trial.
Intervention
25 NA patients will receive a 17-week specific and personalised rehabilitation
program. The program starts with a visit to the Plexuspoli in week 1. During
this visit, the patient will be examined by a multidisciplinary team,
consisting of a rehabilitation physician, neurologist, physical therapist and
occupational therapist, which will form a rehabilitation treatment plan. This
treatment plan is implemented through4 weekly sessions in week 2*5, 2 biweekly
sessions in week 6*9 and 2 monthly sessions in week 10*17. Each treatment
session involves one hour of physical- and one hour of occupational therapy.
25 NA patients will first continue their usual care, which varies for each
individual (including no treatment), for 17 weeks, after which they will also
receive the 17-week specific rehabilitation program at the Radboudumc.
Study burden and risks
Healthy controls will undergo a single assessment (± 3.5 hours). Both the
intervention and usual care groups will undergo a pre- and post-treatment
assessment (± 4.5 hours each). The group initially receiving usual care, will
undergo a third assessment after receiving the intervention. Each assessment
includes an Magnetic Resonance Imaging (MRI) experiment (±1 hour), muscle
strength measurements, a motor imagery behavioural task, recordings of scapular
dyskinesia, and several questionnaires. In a 17-week post-intervention
follow-up, both groups will fill out several questionnaires from home.
Experience gained in pilot studies and the out-patient clinic indicates that
patients can complete the rehabilitation program, lay down in an
MRI-environment, perform scapular and strength assessments and the proposed
motor imagery tasks. We therefore believe that both the treatment and
assessments pose little to no discomfort to participants. NA patients will
likely benefit greatly from participating in the specific rehabilitation
program.
Reinierpostlaan 4
Nijmegen 6525GC
NL
Reinierpostlaan 4
Nijmegen 6525GC
NL
Listed location countries
Age
Inclusion criteria
General:
1. Aged * 18 years
2. Right-handed
3. Able to provide informed consent;Neuralgic amyotrophy (NA) patients:
1. Diagnosis of NA
2. NA predominantly present in the right upper extremity
3. In subacute or chronic phase of NA (i.e. no inflammation of plexus, >2-3 months after attack onset)
4. Presence of scapular dyskinesia
Exclusion criteria
General:
1. Pregnancy
2. Severe comorbidity
3. A history of or recent surgery, biomechanical constraints and/or periarticular fractures of the arm/shoulder
4. Any other neuromusculair disease affecting the shoulder girdle
5. Any central nervous system disorder, neurological disorder (e.g. Parkinson, cerebrovasculair accident, etc.)
For undergoing MRI experiment:
6. Presence of an active implant and/or any non-removable metal parts in or on the upper body
7. Claustrophobia
8. Epilepsy ;NA patients
1. (Prior) NA attacks of the left upper extremity or lumbosacral plexus
2. Patients in the acute phase of NA (characterized by severe pain and inflammation of the brachial plexus)
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 | NL63327.091.17 |