Neuralgic Amyotrophy: Central Reorganization and Rehabilitation After Peripheral Dysfunction

NCT03441347 | Completed

• 1 other identifier: 104752
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuralgic Amyotrophy; Neuralgic Amyotrophy, Hereditary; Parsonage Turner Syndrome; Brachial Neuritis

Keywords

Physical therapy; Occupational therapy; Rehabilitation; Motor control

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (16)

• Change in performance on motor imagery tasks assessing motor control

  Baseline (0 weeks), post-intervention (17 weeks)

• Change in Disability of Shoulder, Arm and Hand (DASH) score from baseline

  Baseline (0 weeks), post-intervention (17 weeks)

• Change in Checklist individual strength - subscale fatigue (CIS-fatigue) score from baseline

  Baseline (0 weeks), post-intervention (17 weeks)

• Change in McGill Pain Questionnaire (MPQ) score from baseline

  Baseline (0 weeks), post-intervention (17 weeks)

• Change in self-efficacy for performing energy conservation strategies assessment (SEPECSA) score from baseline

  Baseline (0 weeks), post-intervention (17 weeks)

Study Arms (2)

Specific rehabilitation program

EXPERIMENTAL

Specific, personalized, multidisciplinary rehabilitation program consisting of physical- and occupational therapy.

Behavioral: Specific rehabilitation program

Usual Care

OTHER

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

Behavioral: Specific rehabilitation program; Other: Usual Care

Interventions

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.

Specific rehabilitation program; Usual Care

Usual Care OTHER

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

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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

You may not qualify if:

• 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

Sponsors & Collaborators

• Radboud University Medical Center: lead
• Princess Beatrix Muscle Foundation: collaborator

Study Sites (1)

Radboud university medical center

Nijmegen, Netherlands

Location

Related Publications (4)

• 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.

  PMID: 24004606 BACKGROUND

• Janssen RMJ, Lustenhouwer R, Cup EHC, van Alfen N, Ijspeert J, Helmich RC, Cameron IGM, Geurts ACH, van Engelen BGM, Graff MJL, Groothuis JT. Effectiveness of an outpatient rehabilitation programme in patients with neuralgic amyotrophy and scapular dyskinesia: a randomised controlled trial. J Neurol Neurosurg Psychiatry. 2023 Jun;94(6):474-481. doi: 10.1136/jnnp-2022-330296. Epub 2023 Jan 25.

  PMID: 36697215 DERIVED

• Lustenhouwer R, Cameron IGM, van Alfen N, Toni I, Geurts ACH, van Engelen BGM, Groothuis JT, Helmich RC. Cerebral Adaptation Associated with Peripheral Nerve Recovery in Neuralgic Amyotrophy: A Randomized Controlled Trial. Neurorehabil Neural Repair. 2023 Jan;37(1):3-15. doi: 10.1177/15459683221145149. Epub 2022 Dec 27.

  PMID: 36575812 DERIVED

• 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.

  PMID: 31391076 DERIVED

MeSH Terms

Conditions

Brachial Plexus Neuritis

Condition Hierarchy (Ancestors)

Brachial Plexus Neuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neuritis

Study Officials

• Jan T Groothuis, PhD, MD

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 15, 2018
• First Posted: February 22, 2018
• Study Start: April 4, 2018
• Primary Completion: February 22, 2021
• Study Completion: February 22, 2021
• Last Updated: March 17, 2021

Record last verified: 2021-03

Locations

NL (1)