deltatrials
Unknown OBSERVATIONAL NCT05088681

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

Sponsor: University of Milano Bicocca

Updated 6 times since 2021 Last updated: Dec 29, 2023 Started: Sep 3, 2021 Primary completion: Apr 30, 2024 Completion: Apr 30, 2024
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This observational or N/A phase trial investigates Peripheral Neuropathies and is currently ongoing. University of Milano Bicocca leads this study, which shows 6 recorded versions since 2021 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Study Description(click to expand)

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...

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).

Status Flow

~Nov 2021 – ~Nov 2022 · 12 months · monthly snapshotRecruiting~Nov 2022 – ~Feb 2024 · 15 months · monthly snapshotRecruiting~Feb 2024 – ~Jul 2024 · 5 months · monthly snapshotRecruiting~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Feb 2026 · 17 months · monthly snapshotRecruiting~Feb 2026 – present · 49 days · monthly snapshot

Change History

6 versions recorded
  1. Feb 2026 — Present [monthly]

    Unknown

    Status: RecruitingUnknown

  2. Sep 2024 — Feb 2026 [monthly]

    Recruiting

  3. Jul 2024 — Sep 2024 [monthly]

    Recruiting

  4. Feb 2024 — Jul 2024 [monthly]

    Recruiting

  5. Nov 2022 — Feb 2024 [monthly]

    Recruiting

Show 1 earlier version
  1. Nov 2021 — Nov 2022 [monthly]

    Recruiting

    First recorded

Sep 2021

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • University of Milano Bicocca
Data source: University of Milano Bicocca

For direct contact, visit the study record on ClinicalTrials.gov .