Synergic Control of Posture in Peripheral Neuropathies' Patients

NCT05088681 | Unknown

• 1 other identifier: NEUPER
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 2

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.

Conditions

Peripheral Neuropathies

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (5)

• Severity of chemotherapy induced-peripheral neuropathy

  At baseline, after the 20th session of the rehabilitation program, follow up at 3 months

• Evaluation of change in electromyography (EMG) parameters

  At baseline, after the 20th session of the rehabilitation program, follow up at 3 months

• Evaluation of change in electromyography (EMG) parameters

  At baseline, after the 20th session of the rehabilitation program, follow up at 3 months

• 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 change in level of disability

  At baseline, after the 20th session of the rehabilitation program, follow up at 3 months

Study Arms (2)

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

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).

Interventions

Rehabilitation program 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.

Peripheral neuropathies patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Peripheral neuropathy patients sent for a neurologic evaluation

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Milano Bicocca: lead

Study Sites (2)

Cecilia Perin

Carate Brianza, Monza E Brianza, 20841, Italy

NOT YET RECRUITING

Paola Alberti

Monza, Monza E Brianza, 20900, Italy

RECRUITING

MeSH Terms

Conditions

Peripheral Nervous System Diseases

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Paola ALberti, MD, PhD

  Università degli Studi di Milano Bicocca

  PRINCIPAL INVESTIGATOR

• Cecilia Perin, MD

  Università degli Studi di Milano Bicocca

  PRINCIPAL INVESTIGATOR

• Guido Cavaletti, MD

  Università degli Studi di Milano Bicocca

  STUDY DIRECTOR

Central Study Contacts

Miryam Mazzucchelli, MD

CONTACT

+39 0362 986201; m.mazzucchelli@campus.unimib.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2021
• First Posted: October 22, 2021
• Study Start: September 3, 2021
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: January 2, 2024

Record last verified: 2023-12

Locations

IT (2)