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Synergic Control of Posture in Peripheral Neuropathies' Patients (NEUPER)

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ClinicalTrials.gov Identifier: NCT05088681
Recruitment Status : Recruiting
First Posted : October 22, 2021
Last Update Posted : January 2, 2024
Sponsor:
Information provided by (Responsible Party):
University of Milano Bicocca

Study Description
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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.

Condition or disease Intervention/treatment
Peripheral Neuropathies Other: Rehabilitation program

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).

Study Design
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Study Type : Observational
Estimated Enrollment : 26 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Synergic Control of Posture in Peripheral Neuropathies' Patients
Actual Study Start Date : September 3, 2021
Estimated Primary Completion Date : April 2024
Estimated Study Completion Date : April 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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
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).


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. Evaluation of balance [ Time Frame: At baseline, after the 20th session of the rehabilitation program, follow up at 3 months ]
    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.

  4. 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.

  5. 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.


Secondary Outcome Measures :
  1. Severity of chemotherapy induced-peripheral neuropathy [ Time Frame: At baseline, after the 20th session of the rehabilitation program, follow up at 3 months ]
    Total Neuropathy Score-clinical version (TNSc©)

  2. Evaluation of change in electromyography (EMG) parameters [ Time Frame: 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.

  3. Evaluation of change in electromyography (EMG) parameters [ Time Frame: At baseline, after the 20th session of the rehabilitation program, follow up at 3 months ]
    Evaluation of motory conduction velocity of ulnar, radial and peroneal nerves.

  4. Impact of PN on patients' quality of life [ Time Frame: At baseline, after the 20th session of the rehabilitation program, follow up at 3 months ]
    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).

  5. Evaluation of change in level of disability [ Time Frame: At baseline, after the 20th session of the rehabilitation program, follow up at 3 months ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Peripheral neuropathy patients sent for a neurologic evaluation
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05088681


Contacts
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Contact: Miryam Mazzucchelli, MD +39 0362 986201 m.mazzucchelli@campus.unimib.it

Locations
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Italy
Cecilia Perin Not yet recruiting
Carate Brianza, Monza E Brianza, Italy, 20841
Contact: Cecilia Perin, MD    +39 0362 986201    cecilia.perin@unimib.it   
Contact: Miryam Mazzucchelli, MD    +39 0362 986201    m.mazzucchelli@campus.unimib.it   
Paola Alberti Recruiting
Monza, Monza E Brianza, Italy, 20900
Contact: Paola Alberti, MD, PhD    +39 02 6448 8154    paola.alberti@unimib.it   
Contact: Miryam Mazzucchelli, MD    + 39 0362 986201    m.mazzucchelli@campus.unimib.it   
Principal Investigator: Paola Alberti, MD, PhD         
Sponsors and Collaborators
University of Milano Bicocca
Investigators
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Principal Investigator: Paola ALberti, MD, PhD Università degli Studi di Milano Bicocca
Principal Investigator: Cecilia Perin, MD Università degli Studi di Milano Bicocca
Study Director: Guido Cavaletti, MD Università degli Studi di Milano Bicocca
More Information
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Responsible Party: University of Milano Bicocca
ClinicalTrials.gov Identifier: NCT05088681    
Other Study ID Numbers: NEUPER
First Posted: October 22, 2021    Key Record Dates
Last Update Posted: January 2, 2024
Last Verified: December 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases