Neuralgic Amyotrophy: Central Reorganization and Rehabilitation After Peripheral Dysfunction

Brachial Neuritis Clinical Trial

— NA-CONTROL  

Official title:

Neuralgic Amyotrophy: Central Reorganization and Rehabilitation After Peripheral Dysfunction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03441347
• Other study ID #: 104752
• Status: Completed
• Phase: N/A
• Start date: April 4, 2018
• Est. completion date: February 22, 2021

Study information

• Verified date: March 2021
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: February 22, 2021
• Est. primary completion date: February 22, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brachial Neuritis
• Gonadal Dysgenesis
• Muscular Atrophy
• Neuralgic Amyotrophy
• Neuralgic Amyotrophy, Hereditary
• Neuritis
• Parsonage Turner Syndrome
• Turner Syndrome

Intervention

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

Locations

Country	Name	City	State
Netherlands	Radboud university medical center	Nijmegen

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University	Princess Beatrix Muscle Foundation

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Shoulder Rating Questionnaire (SRQ) score from baseline	Change in functional (dis)ability of the shoulder, arm and hand measured with the SRQ	Baseline (0 weeks) and post-intervention (17 weeks)
Primary	Change in brain activity related to central motor control from baseline	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	Baseline (0 weeks) and post-intervention (17 weeks)
Secondary	Change in performance on motor imagery tasks assessing motor control	Change in performance on motor imagery tasks. Performance is evaluated by means of reaction times and error rates.	Baseline (0 weeks), post-intervention (17 weeks)
Secondary	Change in Disability of Shoulder, Arm and Hand (DASH) score from baseline	Change in functional (dis)ability of the shoulder, arm and hand measured with the DASH	Baseline (0 weeks), post-intervention (17 weeks)
Secondary	Change in Checklist individual strength - subscale fatigue (CIS-fatigue) score from baseline	Change in experienced fatigue	Baseline (0 weeks), post-intervention (17 weeks)
Secondary	Change in McGill Pain Questionnaire (MPQ) score from baseline	Change in nature, intensity, location, course, and effect on daily life of experienced pain	Baseline (0 weeks), post-intervention (17 weeks)
Secondary	Change in self-efficacy for performing energy conservation strategies assessment (SEPECSA) score from baseline	Change in patient's perceived ability to apply energy conservation strategies to their daily life	Baseline (0 weeks), post-intervention (17 weeks)
Secondary	Change in Utrecht scale for evaluation of rehabilitation-participation (USER-P) score from baseline	Change in patient's participation	Baseline (0 weeks), post-intervention (17 weeks)
Secondary	Change in Pain self efficacy questionnaire (PSEQ) score from baseline	Change in confidence people with ongoing pain have in performing activities while in pain.	Baseline (0 weeks), post-intervention (17 weeks)
Secondary	Change in Patient activation measure (PAM) score from baseline	Change in knowledge, skills and confidence in managing one's own health and/or disease	Baseline (0 weeks), post-intervention (17 weeks)
Secondary	Change in Short-form 36 (SF-36) score from baseline	Change in experienced health and health related quality of life	Baseline (0 weeks), post-intervention (17 weeks)
Secondary	Change in serratus anterior muscle strength from baseline	Change in maximal force exerted with the serratus anterior muscle from baseline, measured when reaching with extended arm and flexed arm	Baseline (0 weeks), post-intervention (17 weeks)
Secondary	Change in shoulder endorotation strength from baseline	Change in maximal force exerted while endorotating the shoulder	Baseline (0 weeks), post-intervention (17 weeks)
Secondary	Change in shoulder exorotation strength from baseline	Change in maximal force exerted while exorotating the shoulder	Baseline (0 weeks), post-intervention (17 weeks)
Secondary	Change in key grip strength from baseline	Change in maximal force exerted while performing a key grip	Baseline (0 weeks), post-intervention (17 weeks)
Secondary	Change in pinch grip strength from baseline	Change in maximal force exerted while performing a pinch grip	Baseline (0 weeks), post-intervention (17 weeks)
Secondary	Change in hand grip strength from baseline	Change in maximal force exerted while performing a hand grip	Baseline (0 weeks), post-intervention (17 weeks)
Secondary	Change in reachable workspace from baseline	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	Baseline (0 weeks), post-intervention (17 weeks)