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

Sponsor

Radboud University Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT03441347

Collaborator

Princess Beatrix Muscle Foundation (Other)

Enrollment

Location

Arms

34.7

Actual Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

47 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.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 :

Apr 4, 2018

Actual Primary Completion Date :

Feb 22, 2021

Actual Study Completion Date :

Feb 22, 2021

Arms and Interventions

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.
Other: 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

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.

Other: Usual Care

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

Behavioral: Specific rehabilitation program

Other: Usual Care

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

Outcome Measures

Primary Outcome Measures

Change in Shoulder Rating Questionnaire (SRQ) score from baseline [Baseline (0 weeks) and post-intervention (17 weeks)]
Change in functional (dis)ability of the shoulder, arm and hand measured with the SRQ
Change in brain activity related to central motor control from baseline [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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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