Back to resultsEfficacy of Hydrotherapy in Peripheral Neuropathy
Primary Purpose
Peripheral Neuropathy
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
hydrotherapy
on land therapy
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Neuropathy
Eligibility Criteria
Inclusion Criteria:
- patients affected by peripherical neuropathy able to walk
Exclusion Criteria:
- pain of water
- medical contraindications at treatment in heated swimming pool
Sites / Locations
- Ospedale generale di zona Moriggia Pelascini
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
hydrotherapy
controls
Arm Description
patients receive daily conventional physiotherapy and three 30- minutes sessions of in- water exercises per week, for four weeks
patients receive daily conventional physiotherapy and three 30- minutes sessions of on- land exercises per week, for four weeks
Outcomes
Primary Outcome Measures
balance change assessed using Berg Balance Scale
disability change assessed using Functional Independence Measure scale
gait change assessed using Dynamic Gait Index scale
gait change assessed using Functional Ambulation Classification scale
pain change assessed using Overall Neuropathy Limitation Scale
disability change assessed using Neuropathy Pain Scale
Secondary Outcome Measures
Full Information
NCT ID
NCT02714517
First Posted
March 10, 2016
Last Updated
September 29, 2016
Sponsor
Ospedale Generale Di Zona Moriggia-Pelascini
1. Study Identification
Unique Protocol Identification Number
NCT02714517
Brief Title
Efficacy of Hydrotherapy in Peripheral Neuropathy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ospedale Generale Di Zona Moriggia-Pelascini
4. Oversight
5. Study Description
Brief Summary
The purpose of the study is to evaluate the efficacy of hydrotherapy on pain and balance in patients affected by neuropathy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Neuropathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
hydrotherapy
Arm Type
Experimental
Arm Description
patients receive daily conventional physiotherapy and three 30- minutes sessions of in- water exercises per week, for four weeks
Arm Title
controls
Arm Type
Active Comparator
Arm Description
patients receive daily conventional physiotherapy and three 30- minutes sessions of on- land exercises per week, for four weeks
Intervention Type
Other
Intervention Name(s)
hydrotherapy
Intervention Description
30 minutes sessions of physiotherapy exercises in heated pool (32°C), three times per week for four weeks
Intervention Type
Other
Intervention Name(s)
on land therapy
Intervention Description
30 minutes sessions of physiotherapy exercises on land, three times per week for four weeks
Primary Outcome Measure Information:
Title
balance change assessed using Berg Balance Scale
Time Frame
0 and 4 weeks
Title
disability change assessed using Functional Independence Measure scale
Time Frame
0 and 4 weeks
Title
gait change assessed using Dynamic Gait Index scale
Time Frame
0 and 4 weeks
Title
gait change assessed using Functional Ambulation Classification scale
Time Frame
0 and 4 weeks
Title
pain change assessed using Overall Neuropathy Limitation Scale
Time Frame
0 and 4 weeks
Title
disability change assessed using Neuropathy Pain Scale
Time Frame
0 and 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
patients affected by peripherical neuropathy able to walk
Exclusion Criteria:
pain of water
medical contraindications at treatment in heated swimming pool
Facility Information:
Facility Name
Ospedale generale di zona Moriggia Pelascini
City
Gravedona ed Uniti
State/Province
CO
ZIP/Postal Code
22015
Country
Italy
12. IPD Sharing Statement
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Efficacy of Hydrotherapy in Peripheral Neuropathy
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