NCT02714517

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 10, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 21, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Last Updated

September 30, 2016

Status Verified

September 1, 2016

Enrollment Period

11 months

First QC Date

March 10, 2016

Last Update Submit

September 29, 2016

Conditions

Peripheral Neuropathy

Outcome Measures

Primary Outcomes (6)

  • balance change assessed using Berg Balance Scale

    0 and 4 weeks

  • disability change assessed using Functional Independence Measure scale

    0 and 4 weeks

  • gait change assessed using Dynamic Gait Index scale

    0 and 4 weeks

  • gait change assessed using Functional Ambulation Classification scale

    0 and 4 weeks

  • pain change assessed using Overall Neuropathy Limitation Scale

    0 and 4 weeks

  • disability change assessed using Neuropathy Pain Scale

    0 and 4 weeks

Study Arms (2)

hydrotherapy

EXPERIMENTAL

patients receive daily conventional physiotherapy and three 30- minutes sessions of in- water exercises per week, for four weeks

Other: hydrotherapy

controls

ACTIVE COMPARATOR

patients receive daily conventional physiotherapy and three 30- minutes sessions of on- land exercises per week, for four weeks

Other: on land therapy

Interventions

hydrotherapyOTHER

30 minutes sessions of physiotherapy exercises in heated pool (32°C), three times per week for four weeks

hydrotherapy
on land therapyOTHER

30 minutes sessions of physiotherapy exercises on land, three times per week for four weeks

controls

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients affected by peripherical neuropathy able to walk

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ospedale generale di zona Moriggia Pelascini

Gravedona Ed Uniti, CO, 22015, Italy

Location

MeSH Terms

Conditions

Peripheral Nervous System Diseases

Interventions

Hydrotherapy

Condition Hierarchy (Ancestors)

Neuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesTherapeuticsRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 10, 2016

First Posted

March 21, 2016

Study Start

July 1, 2015

Primary Completion

June 1, 2016

Last Updated

September 30, 2016

Record last verified: 2016-09

Locations

IT(1)