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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Investigator)
  • Study Primary Completion Date: December 2014

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.

Interventions

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

Arms, Groups and Cohorts

  • Active Comparator: MIRT Group
    • Individuals underwent Multidisciplinary Intensive Rehabilitation Treatment. It consists of 4 weeks of physical therapy in a hospital setting with four daily sessions for five days and one hour of physical exercise on the sixth day.The duration of each session is about one hour. The first session comprises cardiovascular warm-up activities, relaxation and muscle-stretching. The second session includes aerobic exercises and the use of different devices: a stabilometric platform, treadmill plus, crossover, cycloergometer. The third is a session of occupational therapy. The last session includes one hour of speech therapy. The rehabilitation program can also include: robotic-assisted walking training, virtual reality training and meetings with a Psychologist.
  • Experimental: MIRT-AT
    • Patients underwent land-based therapy in association with aquatic therapy, three times per week for four weeks. The land-based activities included the second and the third session of MIRT. The water sessions were divided in 3 phases: i) Warm Up Exercises. This phase lasted 10 minutes and comprised walking performances. ii) Central session Training. This phase lasted 30-45 minutes and comprised trunk mobility exercises in standing position and sitting on a floating device, static and dynamic exercises. The successive balance training exercises comprised: maintaining balance with closed eyes; balance control with one leg resting on a step; postural control changing the support base. iii) Cool-down. This phase lasted 5 minutes and comprised general stretching exercises and gentle walking.

Clinical Trial Outcome Measures

Primary Measures

  • Berg Balance Scale
    • Time Frame: 6 months

Secondary Measures

  • TUG
    • Time Frame: 6 months
  • Unified Parkinson’s Disease Rating Scale II
    • Time Frame: 6 months
  • Unified Parkinson’s Disease Rating Scale III
    • Time Frame: 6 months

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 60 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ospedale Generale Di Zona Moriggia-Pelascini
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ilaria Zivi, MD – Ospedale Generale Di Zona Moriggia-Pelascini
  • Overall Official(s)
    • Giuseppe Frazzitta, MD, Principal Investigator, Department of Parkinson’s Disease and Brain Injury Rehabilitation, of the ‘Moriggia-Pelascini’ Hospital – Gravedona ed Uniti (CO, Italy)

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