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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.
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:
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):
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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:
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| 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):
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Severity of chemotherapy induced-peripheral neuropathy | Total Neuropathy Score-clinical version (TNSc©) | At baseline, after the 20th session of the rehabilitation program, follow up at 3 months |
| Evaluation of change in electromyography (EMG) parameters |
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Inclusion Criteria:
Exclusion Criteria:
A control group of healthy subjects with the same demographic features of peripheral neuropathy patients wil be also included.
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Peripheral neuropathy patients sent for a neurologic evaluation
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Miryam Mazzucchelli, MD | Contact | +39 0362 986201 | m.mazzucchelli@campus.unimib.it |
| Name | Affiliation | Role |
|---|---|---|
| Paola ALberti, MD, PhD | Università degli Studi di Milano Bicocca | Principal Investigator |
| Cecilia Perin, MD | Università degli Studi di Milano Bicocca | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cecilia Perin | Not yet recruiting | Carate Brianza | Monza E Brianza | 20841 | Italy |
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| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| ID | Term |
|---|---|
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| ID | Term |
|---|---|
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
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| At baseline, after the 20th session of the rehabilitation program, follow up at 3 months |
Evaluation of sensory conduction velocity of ulnar, radial and sural nerves. |
| At baseline, after the 20th session of the rehabilitation program, follow up at 3 months |
| Evaluation of change in electromyography (EMG) parameters | Evaluation of motory conduction velocity of ulnar, radial and peroneal nerves. | At baseline, after the 20th session of the rehabilitation program, follow up at 3 months |
| Impact of PN on patients' quality of life | 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). | At baseline, after the 20th session of the rehabilitation program, follow up at 3 months |
| Evaluation of change in level of disability | 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. | At baseline, after the 20th session of the rehabilitation program, follow up at 3 months |
| Guido Cavaletti, MD |
| Università degli Studi di Milano Bicocca |
| Study Director |
| Paola Alberti | Recruiting | Monza | Monza E Brianza | 20900 | Italy |
|
| D006296 |
| Health Services |
| D005159 | Health Care Facilities Workforce and Services |