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

Primary Purpose

Neuralgic Amyotrophy, Neuralgic Amyotrophy, Hereditary, Parsonage Turner Syndrome

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Specific rehabilitation program
Usual Care
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuralgic Amyotrophy focused on measuring Physical therapy, Occupational therapy, Rehabilitation, Motor control

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Radboud university medical center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Specific rehabilitation program

Usual Care

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in Shoulder Rating Questionnaire (SRQ) score from baseline
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
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
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
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
Change in experienced fatigue
Change in McGill Pain Questionnaire (MPQ) score from baseline
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
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
Change in patient's participation
Change in Pain self efficacy questionnaire (PSEQ) score from baseline
Change in confidence people with ongoing pain have in performing activities while in pain.
Change in Patient activation measure (PAM) score from baseline
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
Change in experienced health and health related quality of life
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
Change in shoulder endorotation strength from baseline
Change in maximal force exerted while endorotating the shoulder
Change in shoulder exorotation strength from baseline
Change in maximal force exerted while exorotating the shoulder
Change in key grip strength from baseline
Change in maximal force exerted while performing a key grip
Change in pinch grip strength from baseline
Change in maximal force exerted while performing a pinch grip
Change in hand grip strength from baseline
Change in maximal force exerted while performing a hand grip
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

Full Information

First Posted
February 15, 2018
Last Updated
March 16, 2021
Sponsor
Radboud University Medical Center
Collaborators
Princess Beatrix Muscle Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT03441347
Brief Title
Neuralgic Amyotrophy: Central Reorganization and Rehabilitation After Peripheral Dysfunction
Acronym
NA-CONTROL
Official Title
Neuralgic Amyotrophy: Central Reorganization and Rehabilitation After Peripheral Dysfunction
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
April 4, 2018 (Actual)
Primary Completion Date
February 22, 2021 (Actual)
Study Completion Date
February 22, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radboud University Medical Center
Collaborators
Princess Beatrix Muscle Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuralgic Amyotrophy, Neuralgic Amyotrophy, Hereditary, Parsonage Turner Syndrome, Brachial Neuritis
Keywords
Physical therapy, Occupational therapy, Rehabilitation, Motor control

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan T Groothuis, PhD, MD
Organizational Affiliation
Radboud University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Radboud university medical center
City
Nijmegen
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
24004606
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.
Results Reference
background
PubMed Identifier
31391076
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.
Results Reference
derived

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Neuralgic Amyotrophy: Central Reorganization and Rehabilitation After Peripheral Dysfunction

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