Aquatic Therapy Versus Land-Based Therapy for the Treatment of Balance Dysfunction in Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

Aquatic Therapy Versus Land-Based Therapy for the Treatment of Balance Dysfunction in Parkinson's Disease: a Randomized, Controlled Study With 6-months Follow-up

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02701621
• Other study ID #: ATvsLB Therapy for BD in PD
• Status: Completed
• Phase: N/A
• First received: February 29, 2016
• Last updated: March 7, 2016
• Start date: September 2014
• Est. completion date: December 2014

Study information

• Verified date: March 2016
• Source: Ospedale Generale Di Zona Moriggia-Pelascini
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Local Scientific Committee and Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to compare the effectiveness of a specific aquatic therapy program on balance with a land-based physical-treatment in patients with Parkinson's disease and to evaluate the long-term effects in a 6-month follow-up period.

Description:

Background: Balance dysfunction (BD) in Parkinson's disease (PD) is a disabling sign leading to falls which have a negative impact on the quality of life. It is known that aquatic therapy could be useful to train balance given its physical features and for reducing patients' fear of falls. Many studies have evaluated the efficacy of land-based physiotherapy in treatment of BD, but few studies have investigated the efficacy of aquatic therapy on balance and none of those assessed clinical measurements in a clinically, relevant follow-up period.

Objective: The aim of study was to compare the effectiveness of a specific aquatic therapy program on balance with a land-based physical-treatment in patients with PD and to evaluate the long-term effects in a 6-month follow-up period.

Methods: Thirty-four patients with PD in medium-stage of disease were randomized into two groups: 17 underwent Multidisciplinary-Intensive-Rehabilitation-Treatment (MIRT) and 17 underwent MIRT associated with aquatic therapy protocol (MIRT-AT). Investigators assessed the Berg Balance Scale (BBS), Unified Parkinson's Disease Rating Scale (UPDRS) II-III, and Timed Up Go test (TUG) in both groups at admission, discharge and after a 6-months follow-up period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years to 80 Years

Eligibility

Inclusion Criteria:

• Probable diagnosis of PD according to Gelb et al

• Hoehn & Yahr stage 2.5-3 (H&Y),

• Stable pharmacological treatment for the last 8 weeks and during the hospitalization

• Mini-Mental State Examination (MMSE) = 24

Exclusion Criteria:

• Cardiac and pulmonary diseases

• Urinary incontinence

• History of deep brain stimulation

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Other:
• MIRT-AT
Aquatic therapy
• MIRT
Land-based Therapy

Locations

Country	Name	City	State
Italy	Department of Parkinson's Disease and Brain Injury Rehabilitation, of the 'Moriggia-Pelascini' Hospital	Gravedona ed Uniti	Como

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	Berg Balance Scale		6 months	Yes
Secondary	TUG		6 months	Yes
Secondary	Unified Parkinson's Disease Rating Scale II		6 months	Yes
Secondary	Unified Parkinson's Disease Rating Scale III		6 months	Yes