Neuralgic AmyotrophyNA-CONTROLNCT03441347
Neuralgic Amyotrophy: Central Reorganization and Rehabilitation After Peripheral Dysfunction
A study testing Specific rehabilitation program in people with Neuralgic Amyotrophy and Neuralgic Amyotrophy, Hereditary, run by Radboud University Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neuralgic Amyotrophy, Neuralgic Amyotrophy, Hereditary, Parsonage Turner Syndrome
- What is being tested?
- Specific rehabilitation program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteNetherlands
- Study dates
- 4 Apr 2018to 22 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- (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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Neuralgic Amyotrophy, Neuralgic Amyotrophy, Hereditary, Parsonage Turner Syndrome, Brachial Neuritis
- Being tested
- Specific rehabilitation program, Usual Care
- Keywords
- Physical therapy, Occupational therapy, Rehabilitation, Motor control
- Medical subject headings
- Brachial Plexus Neuritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specific rehabilitation programBehavioural
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.
Usual CareOther
Participants will receive their usual care for 17 weeks, which may vary for each individual
| Study group | Role | What they receive |
|---|---|---|
| Specific rehabilitation program | Experimental | Specific, personalized, multidisciplinary rehabilitation program consisting of physical- and occupational therapy. Receives: Behavioral: Specific rehabilitation program |
| Usual Care | Other | Usual care for people with neuralgic amyotrophy, may vary per individual Receives: Behavioral: Specific rehabilitation program; Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Shoulder Rating Questionnaire (SRQ) score from baseline
Change in functional (dis)ability of the shoulder, arm and hand measured with the SRQ
Measured: 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
Measured: Baseline (0 weeks) and post-intervention (17 weeks)
Secondary outcomes (16)
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.
Measured: Baseline (0 weeks), post-intervention (17 weeks)
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
Measured: Baseline (0 weeks), post-intervention (17 weeks)
Change in Checklist individual strength - subscale fatigue (CIS-fatigue) score from baseline
Change in experienced fatigue
Measured: Baseline (0 weeks), post-intervention (17 weeks)
Change in McGill Pain Questionnaire (MPQ) score from baseline
Change in nature, intensity, location, course, and effect on daily life of experienced pain
Measured: Baseline (0 weeks), post-intervention (17 weeks)
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
Measured: Baseline (0 weeks), post-intervention (17 weeks)
Change in Utrecht scale for evaluation of rehabilitation-participation (USER-P) score from baseline
Change in patient's participation
Measured: Baseline (0 weeks), post-intervention (17 weeks)
Change in Pain self efficacy questionnaire (PSEQ) score from baseline
Change in confidence people with ongoing pain have in performing activities while in pain.
Measured: Baseline (0 weeks), post-intervention (17 weeks)
Change in Patient activation measure (PAM) score from baseline
Change in knowledge, skills and confidence in managing one's own health and/or disease
Measured: Baseline (0 weeks), post-intervention (17 weeks)
Change in Short-form 36 (SF-36) score from baseline
Change in experienced health and health related quality of life
Measured: Baseline (0 weeks), post-intervention (17 weeks)
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
Measured: Baseline (0 weeks), post-intervention (17 weeks)
Change in shoulder endorotation strength from baseline
Change in maximal force exerted while endorotating the shoulder
Measured: Baseline (0 weeks), post-intervention (17 weeks)
Change in shoulder exorotation strength from baseline
Change in maximal force exerted while exorotating the shoulder
Measured: Baseline (0 weeks), post-intervention (17 weeks)
Change in key grip strength from baseline
Change in maximal force exerted while performing a key grip
Measured: Baseline (0 weeks), post-intervention (17 weeks)
Change in pinch grip strength from baseline
Change in maximal force exerted while performing a pinch grip
Measured: Baseline (0 weeks), post-intervention (17 weeks)
Change in hand grip strength from baseline
Change in maximal force exerted while performing a hand grip
Measured: Baseline (0 weeks), post-intervention (17 weeks)
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
Measured: Baseline (0 weeks), post-intervention (17 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start4 Apr 2018
- Primary completion22 Feb 2021
- Study completion22 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Neuralgic AmyotrophyStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Princess Beatrix Muscle Foundation
- Responsible party
- Sponsor
- Investigators
- Jan T Groothuis, PhD, MD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03441347
- Sponsor's protocol ID
- 104752
- Acronym
- NA-CONTROL
- Status last verified
- Mar 2021
- First submitted
- 15 Feb 2018
- Last updated
- 17 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 24004606Janssen 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.
PubMed 36697215Lustenhouwer 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.
PubMed 36575812Lustenhouwer 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.
PubMed 31391076
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuralgic Amyotrophy: Central Reorganization and Rehabilitation After Peripheral Dysfunction
- ClinicalTrials.gov ID
- NCT03441347
- Acronym / sponsor ID
- NA-CONTROL / 104752
- Conditions
- Neuralgic Amyotrophy, Neuralgic Amyotrophy, Hereditary, Parsonage Turner Syndrome, Brachial Neuritis
- Keywords
- Physical therapy, Occupational therapy, Rehabilitation, Motor control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Princess Beatrix Muscle Foundation
- Study start
- 4 Apr 2018 (actual)
- Primary completion
- 22 Feb 2021 (actual)
- Study completion
- 22 Feb 2021 (actual)
- First posted
- 22 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Specific rehabilitation program | Experimental | Behavioral: Specific rehabilitation programSpecific, personalized, multidisciplinary rehabilitation program consisting of physical- and occupational therapy. |
| Usual Care | Other | Behavioral: Specific rehabilitation program, Other: Usual CareUsual care for people with neuralgic amyotrophy, may vary per individual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- (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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Specific rehabilitation program17-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. | Behavioural | Specific rehabilitation program, Usual Care |
| Usual CareParticipants will receive their usual care for 17 weeks, which may vary for each individual | Other | Usual Care |
Primary outcome
Change in Shoulder Rating Questionnaire (SRQ) score from baseline
Time frame: 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
Time frame: 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
16 secondary outcomes
Change in performance on motor imagery tasks assessing motor control
Time frame: Baseline (0 weeks), post-intervention (17 weeks)
Change in Disability of Shoulder, Arm and Hand (DASH) score from baseline
Time frame: Baseline (0 weeks), post-intervention (17 weeks)
Change in Checklist individual strength - subscale fatigue (CIS-fatigue) score from baseline
Time frame: Baseline (0 weeks), post-intervention (17 weeks)
Change in McGill Pain Questionnaire (MPQ) score from baseline
Time frame: Baseline (0 weeks), post-intervention (17 weeks)
Change in self-efficacy for performing energy conservation strategies assessment (SEPECSA) score from baseline
Time frame: Baseline (0 weeks), post-intervention (17 weeks)
Change in Utrecht scale for evaluation of rehabilitation-participation (USER-P) score from baseline
Time frame: Baseline (0 weeks), post-intervention (17 weeks)
Change in Pain self efficacy questionnaire (PSEQ) score from baseline
Time frame: Baseline (0 weeks), post-intervention (17 weeks)
Change in Patient activation measure (PAM) score from baseline
Time frame: Baseline (0 weeks), post-intervention (17 weeks)
Change in Short-form 36 (SF-36) score from baseline
Time frame: Baseline (0 weeks), post-intervention (17 weeks)
Change in serratus anterior muscle strength from baseline
Time frame: Baseline (0 weeks), post-intervention (17 weeks)
Change in shoulder endorotation strength from baseline
Time frame: Baseline (0 weeks), post-intervention (17 weeks)
Change in shoulder exorotation strength from baseline
Time frame: Baseline (0 weeks), post-intervention (17 weeks)
Change in key grip strength from baseline
Time frame: Baseline (0 weeks), post-intervention (17 weeks)
Change in pinch grip strength from baseline
Time frame: Baseline (0 weeks), post-intervention (17 weeks)
Change in hand grip strength from baseline
Time frame: Baseline (0 weeks), post-intervention (17 weeks)
Change in reachable workspace from baseline
Time frame: Baseline (0 weeks), post-intervention (17 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
- Background: PubMed 24004606Ijspeert 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.
- Derived from this study: PubMed 36697215Janssen 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.
- Derived from this study: PubMed 36575812Lustenhouwer 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.
- Derived from this study: PubMed 31391076Lustenhouwer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan T Groothuis, PhD, MD principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Specific rehabilitation program in people with Neuralgic Amyotrophy and Neuralgic Amyotrophy, Hereditary, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Shoulder Rating Questionnaire (SRQ) score from baseline (time frame: Baseline (0 weeks) and post-intervention (17 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03441347, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2021.