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Neuralgic Amyotrophy: Central Reorganization and Rehabilitation After Peripheral Dysfunction (NA-CONTROL)

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ClinicalTrials.gov Identifier: NCT03441347
Recruitment Status : Enrolling by invitation
First Posted : February 21, 2018
Last Update Posted : April 1, 2019
Sponsor:
Collaborator:
Princess Beatrix Muscle Foundation
Information provided by (Responsible Party):
Radboud University

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.


Condition or disease Intervention/treatment Phase
Neuralgic Amyotrophy Neuralgic Amyotrophy, Hereditary Parsonage Turner Syndrome Brachial Neuritis Behavioral: Specific rehabilitation program Other: Usual Care Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Neuralgic Amyotrophy: Central Reorganization and Rehabilitation After Peripheral Dysfunction
Actual Study Start Date : April 4, 2018
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020


Arm Intervention/treatment
Experimental: Specific rehabilitation program
Specific, personalized, multidisciplinary rehabilitation program consisting of physical- and occupational therapy.
Behavioral: 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.

Usual Care
Usual care for people with neuralgic amyotrophy, may vary per individual
Behavioral: 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.

Other: Usual Care
Participants will receive their usual care for 17 weeks, which may vary for each individual




Primary Outcome Measures :
  1. Change in Shoulder Rating Questionnaire (SRQ) score from baseline [ Time Frame: Baseline (0 weeks) and post-intervention (17 weeks) ]
    Change in functional (dis)ability of the shoulder, arm and hand measured with the SRQ

  2. Change in brain activity related to central motor control from baseline [ Time Frame: 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 :
  1. Change in performance on motor imagery tasks assessing motor control [ Time Frame: 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.

  2. Change in Disability of Shoulder, Arm and Hand (DASH) score from baseline [ Time Frame: Baseline (0 weeks), post-intervention (17 weeks) ]
    Change in functional (dis)ability of the shoulder, arm and hand measured with the DASH

  3. Change in Checklist individual strength - subscale fatigue (CIS-fatigue) score from baseline [ Time Frame: Baseline (0 weeks), post-intervention (17 weeks) ]
    Change in experienced fatigue

  4. Change in McGill Pain Questionnaire (MPQ) score from baseline [ Time Frame: Baseline (0 weeks), post-intervention (17 weeks) ]
    Change in nature, intensity, location, course, and effect on daily life of experienced pain

  5. Change in self-efficacy for performing energy conservation strategies assessment (SEPECSA) score from baseline [ Time Frame: Baseline (0 weeks), post-intervention (17 weeks) ]
    Change in patient's perceived ability to apply energy conservation strategies to their daily life

  6. Change in Utrecht scale for evaluation of rehabilitation-participation (USER-P) score from baseline [ Time Frame: Baseline (0 weeks), post-intervention (17 weeks) ]
    Change in patient's participation

  7. Change in Pain self efficacy questionnaire (PSEQ) score from baseline [ Time Frame: Baseline (0 weeks), post-intervention (17 weeks) ]
    Change in confidence people with ongoing pain have in performing activities while in pain.

  8. Change in Patient activation measure (PAM) score from baseline [ Time Frame: Baseline (0 weeks), post-intervention (17 weeks) ]
    Change in knowledge, skills and confidence in managing one's own health and/or disease

  9. Change in Short-form 36 (SF-36) score from baseline [ Time Frame: Baseline (0 weeks), post-intervention (17 weeks) ]
    Change in experienced health and health related quality of life

  10. Change in serratus anterior muscle strength from baseline [ Time Frame: 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

  11. Change in shoulder endorotation strength from baseline [ Time Frame: Baseline (0 weeks), post-intervention (17 weeks) ]
    Change in maximal force exerted while endorotating the shoulder

  12. Change in shoulder exorotation strength from baseline [ Time Frame: Baseline (0 weeks), post-intervention (17 weeks) ]
    Change in maximal force exerted while exorotating the shoulder

  13. Change in key grip strength from baseline [ Time Frame: Baseline (0 weeks), post-intervention (17 weeks) ]
    Change in maximal force exerted while performing a key grip

  14. Change in pinch grip strength from baseline [ Time Frame: Baseline (0 weeks), post-intervention (17 weeks) ]
    Change in maximal force exerted while performing a pinch grip

  15. Change in hand grip strength from baseline [ Time Frame: Baseline (0 weeks), post-intervention (17 weeks) ]
    Change in maximal force exerted while performing a hand grip

  16. Change in reachable workspace from baseline [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03441347


Locations
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Netherlands
Radboud university medical center
Nijmegen, Netherlands
Sponsors and Collaborators
Radboud University
Princess Beatrix Muscle Foundation
Investigators
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Principal Investigator: Jan T Groothuis, PhD, MD Radboud University

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT03441347     History of Changes
Other Study ID Numbers: 104752
First Posted: February 21, 2018    Key Record Dates
Last Update Posted: April 1, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Radboud University:
Physical therapy
Occupational therapy
Rehabilitation
Motor control
Additional relevant MeSH terms:
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Neuritis
Muscular Atrophy
Brachial Plexus Neuritis
Turner Syndrome
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Gonadal Dysgenesis
Disorders of Sex Development
Urogenital Abnormalities
Sex Chromosome Disorders of Sex Development
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Sex Chromosome Disorders
Chromosome Disorders
Genetic Diseases, Inborn
Gonadal Disorders
Endocrine System Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms
Brachial Plexus Neuropathies