Peripheral NeuropathyNCT02714517
Efficacy of Hydrotherapy in Peripheral Neuropathy
A study testing hydrotherapy and on land therapy in people with Peripheral Neuropathy, run by Ospedale Generale Di Zona Moriggia-Pelascini at 1 site in Italy.
Trial summary
The purpose of the study is to evaluate the efficacy of hydrotherapy on pain and balance in patients affected by neuropathy. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Peripheral Neuropathy
- What is being tested?
- hydrotherapy and on land therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2015to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients affected by peripherical neuropathy able to walk
Who cannot join
- pain of water
- medical contraindications at treatment in heated swimming pool
Trial locations and contacts
1 site in 1 country.
Italy1 site
Ospedale generale di zona Moriggia Pelascini
Gravedona Ed Uniti, CO, 22015
About this study
The purpose of the study is to evaluate the efficacy of hydrotherapy on pain and balance in patients affected by neuropathy.
- Conditions
- Peripheral Neuropathy
- Being tested
- hydrotherapy, on land therapy
- Medical subject headings
- Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hydrotherapyOther
30 minutes sessions of physiotherapy exercises in heated pool (32°C), three times per week for four weeks
on land therapyOther
30 minutes sessions of physiotherapy exercises on land, three times per week for four weeks
| Study group | Role | What they receive |
|---|---|---|
| hydrotherapy | Experimental | patients receive daily conventional physiotherapy and three 30- minutes sessions of in- water exercises per week, for four weeks Receives: Other: hydrotherapy |
| controls | Active comparator | patients receive daily conventional physiotherapy and three 30- minutes sessions of on- land exercises per week, for four weeks Receives: Other: on land therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
balance change assessed using Berg Balance Scale
Measured: 0 and 4 weeks
disability change assessed using Functional Independence Measure scale
Measured: 0 and 4 weeks
gait change assessed using Dynamic Gait Index scale
Measured: 0 and 4 weeks
gait change assessed using Functional Ambulation Classification scale
Measured: 0 and 4 weeks
pain change assessed using Overall Neuropathy Limitation Scale
Measured: 0 and 4 weeks
disability change assessed using Neuropathy Pain Scale
Measured: 0 and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2016 (estimated)
- Study startJul 2015
- Primary completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ospedale Generale Di Zona Moriggia-Pelascini
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ilaria Zivi, Ospedale Generale Di Zona Moriggia-Pelascini
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02714517
- Sponsor's protocol ID
- idrokinesi.neuropatie
- Status last verified
- Sep 2016
- First submitted
- 10 Mar 2016
- Last updated
- 30 Sep 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Hydrotherapy in Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT02714517
- Acronym / sponsor ID
- idrokinesi.neuropatie
- Conditions
- Peripheral Neuropathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ospedale Generale Di Zona Moriggia-PelasciniUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Jun 2016 (actual)
- First posted
- 21 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate the efficacy of hydrotherapy on pain and balance in patients affected by neuropathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hydrotherapy | Experimental | Other: hydrotherapypatients receive daily conventional physiotherapy and three 30- minutes sessions of in- water exercises per week, for four weeks |
| controls | Active comparator | Other: on land therapypatients receive daily conventional physiotherapy and three 30- minutes sessions of on- land exercises per week, for four weeks |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients affected by peripherical neuropathy able to walk
Key exclusion criteria (2 listed)
- pain of water
- medical contraindications at treatment in heated swimming pool
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hydrotherapy30 minutes sessions of physiotherapy exercises in heated pool (32°C), three times per week for four weeks | Other | hydrotherapy |
| on land therapy30 minutes sessions of physiotherapy exercises on land, three times per week for four weeks | Other | controls |
Primary outcome
balance change assessed using Berg Balance Scale
Time frame: 0 and 4 weeks
disability change assessed using Functional Independence Measure scale
Time frame: 0 and 4 weeks
gait change assessed using Dynamic Gait Index scale
Time frame: 0 and 4 weeks
gait change assessed using Functional Ambulation Classification scale
Time frame: 0 and 4 weeks
pain change assessed using Overall Neuropathy Limitation Scale
Time frame: 0 and 4 weeks
disability change assessed using Neuropathy Pain Scale
Time frame: 0 and 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hydrotherapy and on land therapy in people with Peripheral Neuropathy, run by Ospedale Generale Di Zona Moriggia-Pelascini at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
balance change assessed using Berg Balance Scale (time frame: 0 and 4 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2016.