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Efficacy of Hydrotherapy in Peripheral Neuropathy

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02714517
Recruitment Status : Completed
First Posted : March 21, 2016
Last Update Posted : September 30, 2016
Sponsor:
Information provided by (Responsible Party):
Ilaria Zivi, Ospedale Generale Di Zona Moriggia-Pelascini

Brief Summary:
The purpose of the study is to evaluate the efficacy of hydrotherapy on pain and balance in patients affected by neuropathy.

Condition or disease Intervention/treatment Phase
Peripheral Neuropathy Other: hydrotherapy Other: on land therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : July 2015
Actual Primary Completion Date : June 2016

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. balance change assessed using Berg Balance Scale [ Time Frame: 0 and 4 weeks ]
  2. disability change assessed using Functional Independence Measure scale [ Time Frame: 0 and 4 weeks ]
  3. gait change assessed using Dynamic Gait Index scale [ Time Frame: 0 and 4 weeks ]
  4. gait change assessed using Functional Ambulation Classification scale [ Time Frame: 0 and 4 weeks ]
  5. pain change assessed using Overall Neuropathy Limitation Scale [ Time Frame: 0 and 4 weeks ]
  6. disability change assessed using Neuropathy Pain Scale [ Time Frame: 0 and 4 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • patients affected by peripherical neuropathy able to walk

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02714517


Locations
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Italy
Ospedale generale di zona Moriggia Pelascini
Gravedona ed Uniti, CO, Italy, 22015
Sponsors and Collaborators
Ospedale Generale Di Zona Moriggia-Pelascini
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Responsible Party: Ilaria Zivi, MD, Ospedale Generale Di Zona Moriggia-Pelascini
ClinicalTrials.gov Identifier: NCT02714517    
Other Study ID Numbers: idrokinesi.neuropatie
First Posted: March 21, 2016    Key Record Dates
Last Update Posted: September 30, 2016
Last Verified: September 2016
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases