- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05088681
Synergic Control of Posture in Peripheral Neuropathies' Patients (NEUPER)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Miryam Mazzucchelli, MD
- Phone Number: +39 0362 986201
- Email: m.mazzucchelli@campus.unimib.it
Study Locations
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Monza E Brianza
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Carate Brianza, Monza E Brianza, Italy, 20841
- Not yet recruiting
- Cecilia Perin
-
Contact:
- Miryam Mazzucchelli, MD
- Phone Number: +39 0362 986201
- Email: m.mazzucchelli@campus.unimib.it
-
Contact:
- Cecilia Perin, MD
- Phone Number: +39 0362 986201
- Email: cecilia.perin@unimib.it
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Monza, Monza E Brianza, Italy, 20900
- Recruiting
- Paola Alberti
-
Contact:
- Paola Alberti, MD, PhD
- Phone Number: +39 02 6448 8154
- Email: paola.alberti@unimib.it
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Principal Investigator:
- Paola Alberti, MD, PhD
-
Contact:
- Miryam Mazzucchelli, MD
- Phone Number: + 39 0362 986201
- Email: m.mazzucchelli@campus.unimib.it
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
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:
|
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):
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
At baseline, after the 20th session of the rehabilitation program, follow up at 3 months
|
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.
|
At baseline, after the 20th session of the rehabilitation program, follow up at 3 months
|
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.
|
At baseline, after the 20th session of the rehabilitation program, follow up at 3 months
|
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.
|
At baseline, after the 20th session of the rehabilitation program, follow up at 3 months
|
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.
|
At baseline, after the 20th session of the rehabilitation program, follow up at 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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©)
|
At baseline, after the 20th session of the rehabilitation program, follow up at 3 months
|
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.
|
At baseline, after the 20th session of the rehabilitation program, follow up at 3 months
|
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.
|
At baseline, after the 20th session of the rehabilitation program, follow up at 3 months
|
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).
|
At baseline, after the 20th session of the rehabilitation program, follow up at 3 months
|
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.
|
At baseline, after the 20th session of the rehabilitation program, follow up at 3 months
|
Collaborators and Investigators
Sponsor
Investigators
- 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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NEUPER
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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