Clinical trial NCT05088681: Synergic Control of Posture in Peripheral Neuropathies' Patients
Official title: Synergic Control of Posture in Peripheral Neuropathies' Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Peripheral Neuropathies
Lead sponsor: University of Milano Bicocca
Sponsor class: OTHER
First posted: 2021-10-22
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Peripheral neuropathy patients sent for a neurologic evaluation

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).

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.

Primary outcomes:
measure: Evaluation of multi-muscle synergy organization using Synergy Index (SI)
timeFrame: At baseline, after the 20th session of the rehabilitation program, follow up at 3 months
measure: Evaluation of change in Anticipatory Synergy Adjustments (ASA)
timeFrame: At baseline, after the 20th session of the rehabilitation program, follow up at 3 months
measure: Evaluation of balance
timeFrame: At baseline, after the 20th session of the rehabilitation program, follow up at 3 months
measure: Evaluation of balance
timeFrame: At baseline, after the 20th session of the rehabilitation program, follow up at 3 months
measure: Evaluation of mobility
timeFrame: At baseline, after the 20th session of the rehabilitation program, follow up at 3 months
Secondary outcomes:
measure: Severity of chemotherapy induced-peripheral neuropathy
timeFrame: At baseline, after the 20th session of the rehabilitation program, follow up at 3 months
measure: Evaluation of change in electromyography (EMG) parameters
timeFrame: At baseline, after the 20th session of the rehabilitation program, follow up at 3 months
measure: Evaluation of change in electromyography (EMG) parameters
timeFrame: At baseline, after the 20th session of the rehabilitation program, follow up at 3 months
measure: Impact of PN on patients' quality of life
timeFrame: At baseline, after the 20th session of the rehabilitation program, follow up at 3 months
measure: Evaluation of change in level of disability
timeFrame: At baseline, after the 20th session of the rehabilitation program, follow up at 3 months
Other outcomes:
Locations:
city: Carate Brianza
country: Italy
facility: Cecilia Perin
state: Monza E Brianza
city: Monza
country: Italy
facility: Paola Alberti
state: Monza E Brianza
Study officials:
affiliation: Università degli Studi di Milano Bicocca
name: Paola ALberti, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Università degli Studi di Milano Bicocca
name: Cecilia Perin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Università degli Studi di Milano Bicocca
name: Guido Cavaletti, MD
role: STUDY_DIRECTOR
References: