Neuralgic Amyotrophy: Central Reorganization and Rehabilitation After Peripheral Dysfunction

Not Applicable

Completed

• Conditions: Brachial Neuritis; Neuralgic Amyotrophy, Hereditary; Parsonage Turner Syndrome; Neuralgic Amyotrophy
• Interventions: Behavioral: Specific rehabilitation program; Other: Usual Care

• Registration Number: NCT03441347
• Lead Sponsor: Radboud University Medical Center

Brief Summary

This study evaluates the effect of a specific, multidisciplinary and personalized rehabilitation program compared to usual care, on motor control and functional disability in patients with neuralgic amyotrophy.

Half of the participants will start with the 17-week specific rehabilitation program while the other half will first continue their usual care for 17 weeks, after which they will also receive the 17-week specific rehabilitation program.

Detailed Description

Neuralgic amyotrophy (NA) is a common (incidence 1:1000) peripheral nervous system disorder caused by acute autoimmune inflammation of the brachial plexus, the nerve bundle going to the shoulder and arm. Many NA patients develop abnormal motor control of the shoulder region (i.e. scapular dyskinesia), which persists even after the peripheral nerve damage has recovered. This suggests that persistent scapular dyskinesia in NA may result from (mal)adaptive changes in the central motor system.

Clinical experience shows that the specific, multidisciplinary and personalized rehabilitation program, focused on cognitive motor control can restore scapular dyskinesia in NA patients. This indicates that impairments in the central motor system likely play a role in persistent scapular dyskinesia and that specific rehabilitation may restore any alterations in central motor control.

We hypothesize that the specific rehabilitation program, focused on cognitive motor control is more effective in improving functional disability than usual care and that it can reverse maladaptive changes in central motor control.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-02-15
• Study First Submitted QC: 2018-02-15
• Study First Posted: 2018-02-22
• Study Start: 2018-04-04
• Primary Completion: 2021-02-22
• Study Completion: 2021-02-22
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-16
• Last Update Posted: 2021-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

• (Suspected) diagnosis of neuralgic amyotrophy
• In subacute or chronic phase of neuralgic amyotrophy (>2 months after attack onset)
• Right-handed
• Neuralgic amyotrophy predominantly present in right upper extremity
• Presence of scapular dyskinesia

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Exclusion Criteria

• Patients in the acute phase of NA (characterized by severe pain and inflammation of the brachial plexus)
• (Prior) NA attacks of the lumbosacral plexus or the left upper extremity
• Sever comorbidity
• Any (bio)mechanical constraints of the shoulder girdle
• Any other central nervous system, neurological, or neuromuscular disorder

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Usual Care	Usual Care	Usual care for people with neuralgic amyotrophy, may vary per individual
Specific rehabilitation program	Specific rehabilitation program	Specific, personalized, multidisciplinary rehabilitation program consisting of physical- and occupational therapy.
Usual Care	Specific rehabilitation program	Usual care for people with neuralgic amyotrophy, may vary per individual

Primary Outcome Measures

Name	Time	Method
Change in Shoulder Rating Questionnaire (SRQ) score from baseline	Baseline (0 weeks) and post-intervention (17 weeks)	Change in functional (dis)ability of the shoulder, arm and hand measured with the SRQ
Change in brain activity related to central motor control from baseline	Baseline (0 weeks) and post-intervention (17 weeks)	Change in the magnitudes of mean functional Magnetic Resonance Imaging signal (Blood-oxygen-level dependent (BOLD) activity) related to motor imagery of the affected arm, quantifying changes in central motor control

Secondary Outcome Measures

Name	Time	Method
Change in performance on motor imagery tasks assessing motor control	Baseline (0 weeks), post-intervention (17 weeks)	Change in performance on motor imagery tasks. Performance is evaluated by means of reaction times and error rates.
Change in Disability of Shoulder, Arm and Hand (DASH) score from baseline	Baseline (0 weeks), post-intervention (17 weeks)	Change in functional (dis)ability of the shoulder, arm and hand measured with the DASH
Change in Checklist individual strength - subscale fatigue (CIS-fatigue) score from baseline	Baseline (0 weeks), post-intervention (17 weeks)	Change in experienced fatigue
Change in McGill Pain Questionnaire (MPQ) score from baseline	Baseline (0 weeks), post-intervention (17 weeks)	Change in nature, intensity, location, course, and effect on daily life of experienced pain
Change in self-efficacy for performing energy conservation strategies assessment (SEPECSA) score from baseline	Baseline (0 weeks), post-intervention (17 weeks)	Change in patient's perceived ability to apply energy conservation strategies to their daily life
Change in Utrecht scale for evaluation of rehabilitation-participation (USER-P) score from baseline	Baseline (0 weeks), post-intervention (17 weeks)	Change in patient's participation
Change in Pain self efficacy questionnaire (PSEQ) score from baseline	Baseline (0 weeks), post-intervention (17 weeks)	Change in confidence people with ongoing pain have in performing activities while in pain.
Change in Patient activation measure (PAM) score from baseline	Baseline (0 weeks), post-intervention (17 weeks)	Change in knowledge, skills and confidence in managing one's own health and/or disease
Change in Short-form 36 (SF-36) score from baseline	Baseline (0 weeks), post-intervention (17 weeks)	Change in experienced health and health related quality of life
Change in serratus anterior muscle strength from baseline	Baseline (0 weeks), post-intervention (17 weeks)	Change in maximal force exerted with the serratus anterior muscle from baseline, measured when reaching with extended arm and flexed arm
Change in shoulder endorotation strength from baseline	Baseline (0 weeks), post-intervention (17 weeks)	Change in maximal force exerted while endorotating the shoulder
Change in shoulder exorotation strength from baseline	Baseline (0 weeks), post-intervention (17 weeks)	Change in maximal force exerted while exorotating the shoulder
Change in key grip strength from baseline	Baseline (0 weeks), post-intervention (17 weeks)	Change in maximal force exerted while performing a key grip
Change in pinch grip strength from baseline	Baseline (0 weeks), post-intervention (17 weeks)	Change in maximal force exerted while performing a pinch grip
Change in hand grip strength from baseline	Baseline (0 weeks), post-intervention (17 weeks)	Change in maximal force exerted while performing a hand grip
Change in reachable workspace from baseline	Baseline (0 weeks), post-intervention (17 weeks)	Reachable workspace is an objective measure of upper extremity impairment. Reachable workspace is quantified by the relative surface area representing the portion of the unit hemisphere that is covered by the hand movements made during a standardized movement protocol which covers cardinal movements of the shoulder

Trial Locations

Locations (1)

Radboud university medical center; 🇳🇱 Nijmegen, Netherlands