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

Not Applicable

Completed

• Conditions: Parkinson Disease

• Registration Number: NCT02701621
• Lead Sponsor: Ospedale Generale Di Zona Moriggia-Pelascini

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2014-09
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Study First Submitted: 2016-02-29
• Status Verified: 2016-03
• Study First Submitted QC: 2016-03-07
• Last Update Submitted: 2016-03-07
• Study First Posted: 2016-03-08
• Last Update Posted: 2016-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Berg Balance Scale	6 months

Secondary Outcome Measures

Name	Time	Method
TUG	6 months
Unified Parkinson's Disease Rating Scale II	6 months
Unified Parkinson's Disease Rating Scale III	6 months

Trial Locations

Locations (1)

Department of Parkinson's Disease and Brain Injury Rehabilitation, of the 'Moriggia-Pelascini' Hospital; 🇮🇹 Gravedona ed Uniti, Como, Italy

Department of Parkinson's Disease and Brain Injury Rehabilitation, of the 'Moriggia-Pelascini' Hospital

🇮🇹Gravedona ed Uniti, Como, Italy