Synergic Control of Posture in Peripheral Neuropathies' Patients (NEUPER)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT05088681 |
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Recruitment Status :
Recruiting
First Posted : October 22, 2021
Last Update Posted : January 2, 2024
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Sponsor:
University of Milano Bicocca
Information provided by (Responsible Party):
University of Milano Bicocca
| Tracking Information | ||||||||||
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| First Submitted Date | September 11, 2021 | |||||||||
| First Posted Date | October 22, 2021 | |||||||||
| Last Update Posted Date | January 2, 2024 | |||||||||
| Actual Study Start Date | September 3, 2021 | |||||||||
| Estimated Primary Completion Date | April 2024 (Final data collection date for primary outcome measure) | |||||||||
| Current Primary Outcome Measures |
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| Original Primary Outcome Measures | Same as current | |||||||||
| Change History | ||||||||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures | Same as current | |||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Descriptive Information | ||||||||||
| Brief Title | Synergic Control of Posture in Peripheral Neuropathies' Patients | |||||||||
| Official Title | Synergic Control of Posture in Peripheral Neuropathies' Patients | |||||||||
| 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:
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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| Study Type | Observational | |||||||||
| Study Design | Observational Model: Case-Control Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | |||||||||
| Biospecimen | Not Provided | |||||||||
| Sampling Method | Non-Probability Sample | |||||||||
| Study Population | Peripheral neuropathy patients sent for a neurologic evaluation | |||||||||
| Condition | Peripheral Neuropathies | |||||||||
| Intervention | 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.
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| Study Groups/Cohorts |
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| Publications * | Not Provided | |||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||||||||
| Recruitment Status | Recruiting | |||||||||
| Estimated Enrollment |
26 | |||||||||
| Original Estimated Enrollment | Same as current | |||||||||
| Estimated Study Completion Date | April 2024 | |||||||||
| Estimated Primary Completion Date | April 2024 (Final data collection date for primary outcome measure) | |||||||||
| Eligibility Criteria | 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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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | |||||||||
| Accepts Healthy Volunteers | Not Provided | |||||||||
| Contacts |
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| Listed Location Countries | Italy | |||||||||
| Removed Location Countries | ||||||||||
| Administrative Information | ||||||||||
| NCT Number | NCT05088681 | |||||||||
| Other Study ID Numbers | NEUPER | |||||||||
| Has Data Monitoring Committee | Not Provided | |||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Current Responsible Party | University of Milano Bicocca | |||||||||
| Original Responsible Party | Same as current | |||||||||
| Current Study Sponsor | University of Milano Bicocca | |||||||||
| Original Study Sponsor | Same as current | |||||||||
| Collaborators | Not Provided | |||||||||
| Investigators |
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| PRS Account | University of Milano Bicocca | |||||||||
| Verification Date | December 2023 | |||||||||