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Neuralgic amyotrophy: Central reorganization and rehabilitation after peripheral dysfunction

Neuralgic amyotrophy: Central reorganization and rehabilitation after peripheral dysfunction - NA-CONTROL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON44371
Enrollment
75
Registered
2018-01-11
Start date
2018-01-04
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuralgic amyotrophy

Interventions

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 b

Sponsors

Radboud Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)