Synergic Control of Posture in Peripheral Neuropathies' Patients (NEUPER)

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 organization.

Study Overview

• Status: Recruiting
• Conditions: Peripheral Neuropathies
• Intervention / Treatment: Other: Rehabilitation program

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).

• Study Type: Observational
• Enrollment (Estimated): 26

Contacts and Locations

• Study Contact: Name: Miryam Mazzucchelli, MD; Phone Number: +39 0362 986201; Email: m.mazzucchelli@campus.unimib.it

Study Locations

• Italy
  • Monza E Brianza
    • Carate Brianza, Monza E Brianza, Italy, 20841
      • Not yet recruiting
      • Cecilia Perin
      • Contact: Miryam Mazzucchelli, MD; Phone Number: +39 0362 986201; Email: m.mazzucchelli@campus.unimib.it
      • Contact: Cecilia Perin, MD; Phone Number: +39 0362 986201; Email: cecilia.perin@unimib.it
    • Monza, Monza E Brianza, Italy, 20900
      • Recruiting
      • Paola Alberti
      • Contact: PAOLA ALBERTI, MD, PhD; Phone Number: +39 02 6448 8154; Email: paola.alberti@unimib.it
      • Principal Investigator: PAOLA ALBERTI, MD, PhD
      • Contact: Miryam Mazzucchelli, MD; Phone Number: + 39 0362 986201; Email: m.mazzucchelli@campus.unimib.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Peripheral neuropathy patients sent for a neurologic evaluation

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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).	Other: Rehabilitation program; 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.
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	At baseline, after the 20th session of the rehabilitation program, follow up at 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of chemotherapy induced-peripheral neuropathy	Total Neuropathy Score-clinical version (TNSc©)	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.	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.	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).	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.	At baseline, after the 20th session of the rehabilitation program, follow up at 3 months

Collaborators and Investigators

• Sponsor: University of Milano Bicocca
• Investigators: Principal Investigator: Paola ALberti, MD, PhD, Università degli Studi di Milano Bicocca; Principal Investigator: Cecilia Perin, MD, Università degli Studi di Milano Bicocca; Study Director: Guido Cavaletti, MD, Università degli Studi di Milano Bicocca

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2021
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: September 11, 2021
• First Submitted That Met QC Criteria: October 8, 2021
• First Posted (Actual): October 22, 2021

Study Record Updates

• Last Update Posted (Estimated): January 1, 2024
• Last Update Submitted That Met QC Criteria: December 29, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases
• Other Study ID Numbers: NEUPER

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No