Efficacy of Hydrotherapy in Peripheral Neuropathy

September 29, 2016 updated by: Ilaria Zivi, Ospedale Generale Di Zona Moriggia-Pelascini
The purpose of the study is to evaluate the efficacy of hydrotherapy on pain and balance in patients affected by neuropathy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • CO
      • Gravedona ed Uniti, CO, Italy, 22015
        • Ospedale Generale di Zona Moriggia Pelascini

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients affected by peripherical neuropathy able to walk

Exclusion Criteria:

  • pain of water
  • medical contraindications at treatment in heated swimming pool

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: hydrotherapy
patients receive daily conventional physiotherapy and three 30- minutes sessions of in- water exercises per week, for four weeks
Other: hydrotherapy
30 minutes sessions of physiotherapy exercises in heated pool (32°C), three times per week for four weeks
Active Comparator: controls
patients receive daily conventional physiotherapy and three 30- minutes sessions of on- land exercises per week, for four weeks
Other: on land therapy
30 minutes sessions of physiotherapy exercises on land, three times per week for four weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
balance change assessed using Berg Balance Scale
Time Frame: 0 and 4 weeks
0 and 4 weeks
disability change assessed using Functional Independence Measure scale
Time Frame: 0 and 4 weeks
0 and 4 weeks
gait change assessed using Dynamic Gait Index scale
Time Frame: 0 and 4 weeks
0 and 4 weeks
gait change assessed using Functional Ambulation Classification scale
Time Frame: 0 and 4 weeks
0 and 4 weeks
pain change assessed using Overall Neuropathy Limitation Scale
Time Frame: 0 and 4 weeks
0 and 4 weeks
disability change assessed using Neuropathy Pain Scale
Time Frame: 0 and 4 weeks
0 and 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ospedale Generale Di Zona Moriggia-Pelascini

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

March 10, 2016

First Submitted That Met QC Criteria

March 15, 2016

First Posted (Estimate)

March 21, 2016

Study Record Updates

Last Update Posted (Estimate)

September 30, 2016

Last Update Submitted That Met QC Criteria

September 29, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • idrokinesi.neuropatie

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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