Clinical trial NCT03441347: Neuralgic Amyotrophy: Central Reorganization and Rehabilitation After Peripheral Dysfunction
Official title: Neuralgic Amyotrophy: Central Reorganization and Rehabilitation After Peripheral Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neuralgic Amyotrophy
Neuralgic Amyotrophy, Hereditary
Parsonage Turner Syndrome
Brachial Neuritis
Keywords: Physical therapy
Occupational therapy
Rehabilitation
Motor control
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Princess Beatrix Muscle Foundation
First posted: 2018-02-22
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Change in Shoulder Rating Questionnaire (SRQ) score from baseline
timeFrame: Baseline (0 weeks) and post-intervention (17 weeks)
measure: Change in brain activity related to central motor control from baseline
timeFrame: Baseline (0 weeks) and post-intervention (17 weeks)
Secondary outcomes:
measure: Change in performance on motor imagery tasks assessing motor control
timeFrame: Baseline (0 weeks), post-intervention (17 weeks)
measure: Change in Disability of Shoulder, Arm and Hand (DASH) score from baseline
timeFrame: Baseline (0 weeks), post-intervention (17 weeks)
measure: Change in Checklist individual strength - subscale fatigue (CIS-fatigue) score from baseline
timeFrame: Baseline (0 weeks), post-intervention (17 weeks)
measure: Change in McGill Pain Questionnaire (MPQ) score from baseline
timeFrame: Baseline (0 weeks), post-intervention (17 weeks)
measure: Change in self-efficacy for performing energy conservation strategies assessment (SEPECSA) score from baseline
timeFrame: Baseline (0 weeks), post-intervention (17 weeks)
measure: Change in Utrecht scale for evaluation of rehabilitation-participation (USER-P) score from baseline
timeFrame: Baseline (0 weeks), post-intervention (17 weeks)
measure: Change in Pain self efficacy questionnaire (PSEQ) score from baseline
timeFrame: Baseline (0 weeks), post-intervention (17 weeks)
measure: Change in Patient activation measure (PAM) score from baseline
timeFrame: Baseline (0 weeks), post-intervention (17 weeks)
measure: Change in Short-form 36 (SF-36) score from baseline
timeFrame: Baseline (0 weeks), post-intervention (17 weeks)
measure: Change in serratus anterior muscle strength from baseline
timeFrame: Baseline (0 weeks), post-intervention (17 weeks)
measure: Change in shoulder endorotation strength from baseline
timeFrame: Baseline (0 weeks), post-intervention (17 weeks)
measure: Change in shoulder exorotation strength from baseline
timeFrame: Baseline (0 weeks), post-intervention (17 weeks)
measure: Change in key grip strength from baseline
timeFrame: Baseline (0 weeks), post-intervention (17 weeks)
measure: Change in pinch grip strength from baseline
timeFrame: Baseline (0 weeks), post-intervention (17 weeks)
measure: Change in hand grip strength from baseline
timeFrame: Baseline (0 weeks), post-intervention (17 weeks)
measure: Change in reachable workspace from baseline
timeFrame: Baseline (0 weeks), post-intervention (17 weeks)
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud university medical center
Study officials:
affiliation: Radboud University Medical Center
name: Jan T Groothuis, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ijspeert J, Janssen RM, Murgia A, Pisters MF, Cup EH, Groothuis JT, van Alfen N. Efficacy of a combined physical and occupational therapy intervention in patients with subacute neuralgic amyotrophy: a pilot study. NeuroRehabilitation. 2013;33(4):657-65. doi: 10.3233/NRE-130993.
citation: Lustenhouwer R, van Alfen N, Cameron IGM, Toni I, Geurts ACH, Helmich RC, van Engelen BGM, Groothuis JT. NA-CONTROL: a study protocol for a randomised controlled trial to compare specific outpatient rehabilitation that targets cerebral mechanisms through relearning motor control and uses self-management strategies to improve functional capability of the upper extremity, to usual care in patients with neuralgic amyotrophy. Trials. 2019 Aug 7;20(1):482. doi: 10.1186/s13063-019-3556-4.