Synergic Control of Posture in Peripheral Neuropathies' Patients

Recruiting

• Conditions: Peripheral Neuropathies
• Interventions: Other: Rehabilitation program

• Registration Number: NCT05088681
• Lead Sponsor: University of Milano Bicocca

Brief 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 organization.

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 Timeline

• Study Start: 2021-09-03
• Study First Submitted: 2021-09-11
• Study First Submitted QC: 2021-10-08
• Study First Posted: 2021-10-22
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-29
• Last Update Posted: 2024-01-02
• Primary Completion: 2024-04
• Study Completion: 2024-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 26

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Peripheral neuropathies patients	Rehabilitation program	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).

Primary Outcome Measures

Name	Time	Method
Evaluation of balance	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 change in Anticipatory Synergy Adjustments (ASA)	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 mobility	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.
Evaluation of multi-muscle synergy organization using Synergy Index (SI)	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.

Secondary Outcome Measures

Name	Time	Method
Severity of chemotherapy induced-peripheral neuropathy	At baseline, after the 20th session of the rehabilitation program, follow up at 3 months	Total Neuropathy Score-clinical version (TNSc©)
Evaluation of change in electromyography (EMG) parameters	At baseline, after the 20th session of the rehabilitation program, follow up at 3 months	Evaluation of motory conduction velocity of ulnar, radial and peroneal nerves.
Impact of PN on patients' quality of life	At baseline, after the 20th session of the rehabilitation program, follow up at 3 months	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).
Evaluation of change in level of disability	At baseline, after the 20th session of the rehabilitation program, follow up at 3 months	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.

Trial Locations

Locations (2)

Paola Alberti; 🇮🇹 Monza, Monza E Brianza, Italy

Cecilia Perin; 🇮🇹 Carate Brianza, Monza E Brianza, Italy