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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02714517
Other study ID # idrokinesi.neuropatie
Secondary ID
Status Completed
Phase N/A
First received March 10, 2016
Last updated September 29, 2016
Start date July 2015

Study information

Verified date September 2016
Source Ospedale Generale Di Zona Moriggia-Pelascini
Contact n/a
Is FDA regulated No
Health authority Italy: Ethics Committee
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date
Est. primary completion date June 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- patients affected by peripherical neuropathy able to walk

Exclusion Criteria:

- pain of water

- medical contraindications at treatment in heated swimming pool

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
hydrotherapy
30 minutes sessions of physiotherapy exercises in heated pool (32°C), three times per week for four weeks
on land therapy
30 minutes sessions of physiotherapy exercises on land, three times per week for four weeks

Locations

Country Name City State
Italy Ospedale generale di zona Moriggia Pelascini Gravedona ed Uniti CO

Sponsors (1)

Lead Sponsor Collaborator
Ospedale Generale Di Zona Moriggia-Pelascini

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary balance change assessed using Berg Balance Scale 0 and 4 weeks No
Primary disability change assessed using Functional Independence Measure scale 0 and 4 weeks No
Primary gait change assessed using Dynamic Gait Index scale 0 and 4 weeks No
Primary gait change assessed using Functional Ambulation Classification scale 0 and 4 weeks Yes
Primary pain change assessed using Overall Neuropathy Limitation Scale 0 and 4 weeks No
Primary disability change assessed using Neuropathy Pain Scale 0 and 4 weeks No
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