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Completed

NCT Number: NCT03441347

Neuralgic Amyotrophy: Central Reorganization and Rehabilitation After Peripheral Dysfunction

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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Key information

Conditions

Neuralgic Amyotrophy Brachial Neuritis Brachial Plexus Neuritis Brachial Plexus Neuropathies Nervous System Diseases Neuralgic Amyotrophy, Hereditary Neuritis Neuromuscular Diseases Parsonage Turner Syndrome Peripheral Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Radboud university medical center

Nijmegen, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Specific rehabilitation program

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

Other

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Collaborators

  • Princess Beatrix Muscle Foundation

Registry information

Acronym: NA-CONTROL

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Feb 22, 2018
Registry last updated
Mar 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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