Peripheral NeuropathiesNEUPERNCT05088681

Synergic Control of Posture in Peripheral Neuropathies' Patients

An observational study of Peripheral Neuropathies, run by University of Milano Bicocca at 2 sites in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Trial summary

This is a multicenter observational study aimed to characterize multi-muscle synergy organization in relation to postural stability in individuals with Peripheral Neuropathies (PN) compared to healthy age-matched subjects and to assess the effectiveness of a rehabilitation program driven by multi-muscle synergy… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Peripheral Neuropathies
What is being tested?: Rehabilitation program
How many people: 26 participants
Where: 2 sitesItaly
Study dates: 3 Sep 2021to Apr 2024
Phase: Observational
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
Adult, Older adult

Study population: Peripheral neuropathy patients sent for a neurologic evaluation

Who may be able to join

Subject suffering from peripheral neuropathy with a TNSc© score more than 4
male and female subjects who are 18 years of age or older

Who cannot join

orthopedic or neurologic comorbidities that can influence postural control
A control group of healthy subjects with the same demographic features of peripheral neuropathy patients wil be also included.

Trial locations and contacts

2 sites in 1 country.

Miryam Mazzucchelli, MD contact

+39 0362 986201

m.mazzucchelli@campus.unimib.it

Italy2 sites, 2 recruiting

Cecilia Perin
Carate Brianza, Monza E Brianza, 20841
Cecilia Perin, MD, +39 0362 986201, cecilia.perin@unimib.it
Miryam Mazzucchelli, MD, +39 0362 986201, m.mazzucchelli@campus.unimib.it
Not yet recruiting
Paola Alberti
Monza, Monza E Brianza, 20900
Paola Alberti, MD, PhD, +39 02 6448 8154, paola.alberti@unimib.it
Miryam Mazzucchelli, MD, + 39 0362 986201, m.mazzucchelli@campus.unimib.it
Recruiting

Other trials in Italy

About this study

Read the detailed description

This is a multicenter observational study of peripheral neuropathies patients aiming at characterizing multi-muscle synergy and at assessing the effectiveness of a rehabilitation program driven by multi-muscle synergy organization.

The study can be divided in two phases:

Phase 1 will included peripheral neuropathies patients and healthy age-matched subjects.

Peripheral neuropathies patients will be assessed with:

Neurological assessment formalized via Total Neuropathy Score-clinical version (TNSc©)
Nerve conduction studies
Impact of PN on patients' quality of life using Short Form Health Survey 36 (SF-36)
Functional status using Functional Independence Measure (FIM)

Peripheral neuropathies patients and healthy age-matched subjects will receive a postural evaluation recording during three different postural tasks (quiet standing, voluntary sway and shoulder flexion):

centre of pressure (COP) displacement of force platform;
surface muscle activation using electromyography (EMG) of 13 muscle on the right side of the body (tibialis anterior, soleus,gastrocnemius lateralis-medialis, biceps femoris, semitendinosus, rectus femoris, vastus lateralis and medialis, tensor fasciae latae, lumbar and thoracic erector spinae and rectus abdominis).

Phase 2 will included only peripheral neuropathies patients. Participants will be assessed at baseline, after a 20 session 2-3/w program of physical therapy and at a follow up of 3 months.

The evaluations of the first phase will be implemented with evaluation of mobility and balance using Six Minute Walking Test (6MWT), Mini Balance Evaluation System Test (MiniBESTest) and Timed Up and Go test (TUG).

Conditions: Peripheral Neuropathies
Being tested: Rehabilitation program
Medical subject headings: Peripheral Nervous System Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Rehabilitation programOther
The exercise intervention will consist of an individualized prescription of resistance training, balance training and cardiovascular exercises delivered for 20 session, one-hour, two/three times per week.

Study groups in NCT05088681
Study group	Role	What they receive
Peripheral neuropathies patients		Peripheral neuropathies patients will be assessed at baseline, after a 20 session 2-3/w program of physical therapy and at a follow up of 3 months with: * Total Neuropathy Score-clinical version (TNSc©) * Nerve conduction studies * Short Form Health Survey 36 (SF-36) * Functional Independence Measure (FIM) * postural evaluation recording during three different postural tasks (quiet standing, voluntary sway and shoulder flexion):centre of pressure (COP) displacement of force platform; surface muscle activation using electromyography (EMG) of 13 muscle on the right side of the body (tibialis anterior, soleus,gastrocnemius lateralis-medialis, biceps femoris, semitendinosus, rectus femoris, vastus lateralis and medialis, tensor fasciae latae, lumbar and thoracic erector spinae and rectus abdominis) * Six Minute Walking Test (6MWT), Mini Balance Evaluation System Test (MiniBESTest) and Timed Up and Go test (TUG). Receives: Other: Rehabilitation program
Healthy age-matched subjects		Healthy age-matched subjects will receive a postural evaluation recording during three different postural tasks (quiet standing, voluntary sway and shoulder flexion): * centre of pressure (COP) displacement of force platform; * surface muscle activation using electromyography (EMG) of 13 muscle on the right side of the body (tibialis anterior, soleus,gastrocnemius lateralis-medialis, biceps femoris, semitendinosus, rectus femoris, vastus lateralis and medialis, tensor fasciae latae, lumbar and thoracic erector spinae and rectus abdominis).

What is being measured

The primary outcome is the main question the study is designed to answer.

Evaluation of multi-muscle synergy organization using Synergy Index (SI)
Multi-muscle Synergy Index (SI) are new measurements of postural stability and a proxy of multi-muscle coordination. Synergy has been defined as a neural organization of a large set of effectors (e.g., muscles) providing stability of salient performance variables (e.g., center of pressure, COP). Within this framework, SI has been introduced, reflecting the relative amount of inter-trial variance that does not affect a performance variable.
Measured: At baseline, after the 20th session of the rehabilitation program, follow up at 3 months
Evaluation of change in Anticipatory Synergy Adjustments (ASA)
ASAs represent changes in an index of a multi-muscle synergy stabilizing the coordinate of the center of pressure (COP). Such changes may be seen in young, healthy persons about 200-300 ms prior to the action initiation.
Measured: At baseline, after the 20th session of the rehabilitation program, follow up at 3 months
Evaluation of balance
Evaluation of balance using Mini Balance Evaluation System Test (MiniBESTest). Each item is scored on a 0-4 scale; the scores are summed to obtain a total score of 28. The item are divided in four sessions: anticipatory, reactive postural control, sensory orientation, dynamic gait.
Measured: At baseline, after the 20th session of the rehabilitation program, follow up at 3 months
Evaluation of balance
Evaluation of balance using Timed Up and Go test (TUG). It is a measure of the time taken by the patient for rising from a chair, walking three meters, turning and walking back to the chair to sit down.
Measured: At baseline, after the 20th session of the rehabilitation program, follow up at 3 months
Evaluation of mobility
Evaluation of mobility using Six Minute Walking Test (6MWT). The 6MWT assesses distance walked over six minutes as a sub-maximal test of endurance/aerobic capacity.
Measured: At baseline, after the 20th session of the rehabilitation program, follow up at 3 months

Secondary outcomes (5)

Severity of chemotherapy induced-peripheral neuropathy
Total Neuropathy Score-clinical version (TNSc©)
Measured: At baseline, after the 20th session of the rehabilitation program, follow up at 3 months
Evaluation of change in electromyography (EMG) parameters
Evaluation of sensory conduction velocity of ulnar, radial and sural nerves.
Measured: At baseline, after the 20th session of the rehabilitation program, follow up at 3 months
Evaluation of change in electromyography (EMG) parameters
Evaluation of motory conduction velocity of ulnar, radial and peroneal nerves.
Measured: At baseline, after the 20th session of the rehabilitation program, follow up at 3 months
Impact of PN on patients' quality of life
Evaluation of quality of life using the Short Form Health Survey 36 (SF-36). It is a self-report measure of functional health and well-being. The SF-36 questionnaire consists of eight scales yielding two summary measures: physical and mental health. The physical health measure includes four scales of physical functioning (10 items), role-physical (4 items), bodily pain (2 items), and general health (5 items). The mental health measure is composed of vitality (4 items), social functioning (2 items), role-emotional (3 items), and mental health (5 items).
Measured: At baseline, after the 20th session of the rehabilitation program, follow up at 3 months
Evaluation of change in level of disability
Evaluation of level of disability using Functional Independence Measure (FIM). It is an 18-item, seven-level, ordinal scale intended to be sensitive to changes over the course of a comprehensive inpatient medical rehabilitation program.It includes measures of independence for self-care, including sphincter control, transfers, locomotion, communication, and social cognition.
Measured: At baseline, after the 20th session of the rehabilitation program, follow up at 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Sep 2021Apr 2024

First posted22 Oct 2021
Study start3 Sep 2021
Primary completionApr 2024 (estimated)
Study completionApr 2024 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Peripheral NeuropathiesStudies of the same condition, open and under way.
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: Observational
Observational model: Case-control
Time perspective: Prospective
Enrolment: 26 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05088681
Sponsor's protocol ID: NEUPER
Acronym: NEUPER
Status last verified: Dec 2023
First submitted: 11 Sep 2021
Last updated: 2 Jan 2024
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

Miryam Mazzucchelli, MD

+39 0362 986201

m.mazzucchelli@campus.unimib.it

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Peripheral Neuropathies trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Synergic Control of Posture in Peripheral Neuropathies' Patients
ClinicalTrials.gov ID: NCT05088681
Acronym / sponsor ID: NEUPER / NEUPER
Conditions: Peripheral Neuropathies
Study type: Observational
Recruitment status: Unknown status
Enrolment: 26 participants (estimated)
Lead sponsor: University of Milano BicoccaUniversity, hospital or other
Study start: 3 Sep 2021 (actual)
Primary completion: Apr 2024 (estimated)
Study completion: Apr 2024 (estimated)
First posted: 22 Oct 2021 (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.

Detailed description

The study can be divided in two phases:

Phase 1 will included peripheral neuropathies patients and healthy age-matched subjects.

Peripheral neuropathies patients will be assessed with:

Neurological assessment formalized via Total Neuropathy Score-clinical version (TNSc©)
Nerve conduction studies
Impact of PN on patients' quality of life using Short Form Health Survey 36 (SF-36)
Functional status using Functional Independence Measure (FIM)

centre of pressure (COP) displacement of force platform;
surface muscle activation using electromyography (EMG) of 13 muscle on the right side of the body (tibialis anterior, soleus,gastrocnemius lateralis-medialis, biceps femoris, semitendinosus, rectus femoris, vastus lateralis and medialis, tensor fasciae latae, lumbar and thoracic erector spinae and rectus abdominis).

Phase 2 will included only peripheral neuropathies patients. Participants will be assessed at baseline, after a 20 session 2-3/w program of physical therapy and at a follow up of 3 months.

Study design

Observational model: Case-control
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Peripheral neuropathies patients	–	Other: Rehabilitation programPeripheral neuropathies patients will be assessed at baseline, after a 20 session 2-3/w program of physical therapy and at a follow up of 3 months with: * Total Neuropathy Score-clinical version (TNSc©) * Nerve conduction studies * Short Form Health Survey 36 (SF-36) * Functional Independence Measure (FIM) * postural evaluation recording during three different postural tasks (quiet standing, voluntary sway and shoulder flexion):centre of pressure (COP) displacement of force platform; surface muscle activation using electromyography (EMG) of 13 muscle on the right side of the body (tibialis anterior, soleus,gastrocnemius lateralis-medialis, biceps femoris, semitendinosus, rectus femoris, vastus lateralis and medialis, tensor fasciae latae, lumbar and thoracic erector spinae and rectus abdominis) * Six Minute Walking Test (6MWT), Mini Balance Evaluation System Test (MiniBESTest) and Timed Up and Go test (TUG).
Healthy age-matched subjects	–	–Healthy age-matched subjects will receive a postural evaluation recording during three different postural tasks (quiet standing, voluntary sway and shoulder flexion): * centre of pressure (COP) displacement of force platform; * surface muscle activation using electromyography (EMG) of 13 muscle on the right side of the body (tibialis anterior, soleus,gastrocnemius lateralis-medialis, biceps femoris, semitendinosus, rectus femoris, vastus lateralis and medialis, tensor fasciae latae, lumbar and thoracic erector spinae and rectus abdominis).

Who may qualify

Ages: 18 years and older
Sex: All
Age groups: Adult, Older adult
Study population: Peripheral neuropathy patients sent for a neurologic evaluation

Key inclusion criteria (2 listed)

Subject suffering from peripheral neuropathy with a TNSc© score more than 4
male and female subjects who are 18 years of age or older

Key exclusion criteria (2 listed)

orthopedic or neurologic comorbidities that can influence postural control
A control group of healthy subjects with the same demographic features of peripheral neuropathy patients wil be also included.

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
Rehabilitation programThe exercise intervention will consist of an individualized prescription of resistance training, balance training and cardiovascular exercises delivered for 20 session, one-hour, two/three times per week.	Other	Peripheral neuropathies patients

Primary outcome

Evaluation of multi-muscle synergy organization using Synergy Index (SI)
Time frame: At baseline, after the 20th session of the rehabilitation program, follow up at 3 months
Multi-muscle Synergy Index (SI) are new measurements of postural stability and a proxy of multi-muscle coordination. Synergy has been defined as a neural organization of a large set of effectors (e.g., muscles) providing stability of salient performance variables (e.g., center of pressure, COP). Within this framework, SI has been introduced, reflecting the relative amount of inter-trial variance that does not affect a performance variable.
Evaluation of change in Anticipatory Synergy Adjustments (ASA)
Time frame: At baseline, after the 20th session of the rehabilitation program, follow up at 3 months
ASAs represent changes in an index of a multi-muscle synergy stabilizing the coordinate of the center of pressure (COP). Such changes may be seen in young, healthy persons about 200-300 ms prior to the action initiation.
Evaluation of balance
Time frame: At baseline, after the 20th session of the rehabilitation program, follow up at 3 months
Evaluation of balance using Mini Balance Evaluation System Test (MiniBESTest). Each item is scored on a 0-4 scale; the scores are summed to obtain a total score of 28. The item are divided in four sessions: anticipatory, reactive postural control, sensory orientation, dynamic gait.
Evaluation of balance
Time frame: At baseline, after the 20th session of the rehabilitation program, follow up at 3 months
Evaluation of balance using Timed Up and Go test (TUG). It is a measure of the time taken by the patient for rising from a chair, walking three meters, turning and walking back to the chair to sit down.
Evaluation of mobility
Time frame: At baseline, after the 20th session of the rehabilitation program, follow up at 3 months
Evaluation of mobility using Six Minute Walking Test (6MWT). The 6MWT assesses distance walked over six minutes as a sub-maximal test of endurance/aerobic capacity.

5 secondary outcomes

Severity of chemotherapy induced-peripheral neuropathy
Time frame: At baseline, after the 20th session of the rehabilitation program, follow up at 3 months
Evaluation of change in electromyography (EMG) parameters
Time frame: At baseline, after the 20th session of the rehabilitation program, follow up at 3 months
Evaluation of change in electromyography (EMG) parameters
Time frame: At baseline, after the 20th session of the rehabilitation program, follow up at 3 months
Impact of PN on patients' quality of life
Time frame: At baseline, after the 20th session of the rehabilitation program, follow up at 3 months
Evaluation of change in level of disability
Time frame: At baseline, after the 20th session of the rehabilitation program, follow up at 3 months

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2024.
Individual participant dataSharing planned: Undecided

Related trials for Peripheral Neuropathies

Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruitingObservational study
Postural Control and Balance Performance in Patients With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS), Postural Assessment
Active, not recruiting
The AIUR Trial: Surgical Gloves to Prevent Peripheral Neuropathy
Chemotherapy-induced Peripheral Neuropathy
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis

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.

Miryam Mazzucchelli, MD contact

+39 0362 986201

m.mazzucchelli@campus.unimib.it

Paola ALberti, MD, PhD principal investigator

Università degli Studi di Milano Bicocca

Cecilia Perin, MD principal investigator

Università degli Studi di Milano Bicocca

Guido Cavaletti, MD study director

Università degli Studi di Milano Bicocca

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Peripheral Neuropathies, run by University of Milano Bicocca at 2 sites in Italy.

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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 2 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Italy. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Miryam Mazzucchelli, MD (+39 0362 986201, m.mazzucchelli@campus.unimib.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of multi-muscle synergy organization using Synergy Index (SI) (time frame: At baseline, after the 20th session of the rehabilitation program, follow up at 3 months). The study lists 5 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 NCT05088681.

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 2 Jan 2024.