Neuralgic Amyotrophy: Central Reorganization and Rehabilitation After Peripheral Dysfunction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-04

Study Completion Date

2021-02-22

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Neuralgic Amyotrophy Neuralgic Amyotrophy, Hereditary Parsonage Turner Syndrome Brachial Neuritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Patients in the experimental arm start the 17 week experimental intervention right after they enter the study. Patients in the second arm first continue to receive their usual care for 17 weeks, after which they also receive the experimental intervention. Both groups are assessed at baseline and after the initial 17 weeks. The second group is assessed a third time, after they have completed the 17-week experimental treatment program.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Specific rehabilitation program

Specific, personalized, multidisciplinary rehabilitation program consisting of physical- and occupational therapy.

Group Type EXPERIMENTAL

Specific rehabilitation program

Intervention Type BEHAVIORAL

17-week specific and personalised rehabilitation program. The program starts with a visit to the Plexus out patient clinic 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 through 4 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.

Usual Care

Usual care for people with neuralgic amyotrophy, may vary per individual

Group Type OTHER

Specific rehabilitation program

Intervention Type BEHAVIORAL

17-week specific and personalised rehabilitation program. The program starts with a visit to the Plexus out patient clinic 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 through 4 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.

Usual Care

Intervention Type OTHER

Participants will receive their usual care for 17 weeks, which may vary for each individual

Interventions

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Specific rehabilitation program

17-week specific and personalised rehabilitation program. The program starts with a visit to the Plexus out patient clinic 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 through 4 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.

Intervention Type BEHAVIORAL

Usual Care

Participants will receive their usual care for 17 weeks, which may vary for each individual

Intervention Type OTHER

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes