Synergic Control of Posture in Peripheral Neuropathies' Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Milano Bicocca
- Enrollment
- 26
- Locations
- 2
- Primary Endpoint
- Evaluation of balance
Study Overview
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)
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Evaluation of balance
Time Frame: 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)
Time Frame: 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
Time Frame: 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)
Time Frame: 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 Outcomes
- 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)
- 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 level of disability(At baseline, after the 20th session of the rehabilitation program, follow up at 3 months)