- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02714517
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
-
-
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
|
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
|
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.
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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-
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WinSanTor, IncRecruitingChemotherapy-induced Peripheral NeuropathyUnited States
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-
National University Hospital, SingaporePaxman Coolers Ltd.; The N.1 Institute for Health, National University of SingaporeRecruitingChemotherapy-induced Peripheral NeuropathySingapore
Clinical Trials on hydrotherapy
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Pierre Fabre Dermo CosmetiqueCompletedChronic Pruritus Due to Plaque PsoriasisSpain, France
-
Mariana Arias AvilaCompleted
-
Lancashire Teaching Hospitals NHS Foundation TrustDuchenne UKRecruiting
-
Hadassah Medical OrganizationCompletedOsteoarthritis | Total Knee ReplacementIsrael
-
University of ThessalyActive, not recruiting
-
Universidad del Valle, ColombiaUnknownNeuropathic Pain | Spinal Cord InjuriesColombia
-
Chinese University of Hong KongCompleted
-
Kırklareli UniversityCompleted
-
Cairo UniversityRecruitingPostmenopausal WomenEgypt
-
University of Castilla-La ManchaCompletedSpinal Cord InjuriesSpain