Synergic Control of Posture in Peripheral Neuropathies' Patients

NCT ID: NCT05088681

Last Updated: 2024-01-02

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 26 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-09-03
• Study Completion Date: 2024-04-30

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).

Conditions

Peripheral Neuropathies

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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).

Rehabilitation program

Intervention Type: OTHER

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).

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Milano Bicocca

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paola ALberti, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Università degli Studi di Milano Bicocca

Cecilia Perin, MD

Role: PRINCIPAL_INVESTIGATOR

Università degli Studi di Milano Bicocca

Guido Cavaletti, MD

Role: STUDY_DIRECTOR

Università degli Studi di Milano Bicocca

Locations

Cecilia Perin

Carate Brianza, Monza E Brianza, Italy

Site Status: NOT_YET_RECRUITING

Paola Alberti

Monza, Monza E Brianza, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Miryam Mazzucchelli, MD

Role: CONTACT

m.mazzucchelli@campus.unimib.it

+39 0362 986201

Facility Contacts

Cecilia Perin, MD

Role: primary

cecilia.perin@unimib.it

+39 0362 986201

Miryam Mazzucchelli, MD

Role: backup

m.mazzucchelli@campus.unimib.it

+39 0362 986201

Paola Alberti, MD, PhD

Role: primary

paola.alberti@unimib.it

+39 02 6448 8154

Miryam Mazzucchelli, MD

Role: backup

m.mazzucchelli@campus.unimib.it

+ 39 0362 986201

Other Identifiers

NEUPER

Identifier Type: -

Identifier Source: org_study_id