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

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
MIRT-AT
MIRT
Sponsored by
Ospedale Generale Di Zona Moriggia-Pelascini
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson's disease, aquatic therapy, balance, MIRT

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

MIRT Group

MIRT-AT

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Berg Balance Scale

Secondary Outcome Measures

TUG
Unified Parkinson's Disease Rating Scale II
Unified Parkinson's Disease Rating Scale III

Full Information

First Posted
February 29, 2016
Last Updated
March 7, 2016
Sponsor
Ospedale Generale Di Zona Moriggia-Pelascini
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1. Study Identification

Unique Protocol Identification Number
NCT02701621
Brief Title
Aquatic Therapy Versus Land-Based Therapy for the Treatment of Balance Dysfunction in Parkinson's Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ospedale Generale Di Zona Moriggia-Pelascini

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson's disease, aquatic therapy, balance, MIRT

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MIRT Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
MIRT-AT
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
MIRT-AT
Intervention Description
Aquatic therapy
Intervention Type
Other
Intervention Name(s)
MIRT
Intervention Description
Land-based Therapy
Primary Outcome Measure Information:
Title
Berg Balance Scale
Time Frame
6 months
Secondary Outcome Measure Information:
Title
TUG
Time Frame
6 months
Title
Unified Parkinson's Disease Rating Scale II
Time Frame
6 months
Title
Unified Parkinson's Disease Rating Scale III
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giuseppe Frazzitta, MD
Organizational Affiliation
Department of Parkinson's Disease and Brain Injury Rehabilitation, of the 'Moriggia-Pelascini' Hospital - Gravedona ed Uniti (CO, Italy)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Parkinson's Disease and Brain Injury Rehabilitation, of the 'Moriggia-Pelascini' Hospital
City
Gravedona ed Uniti
State/Province
Como
ZIP/Postal Code
22015
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28254636
Citation
Palamara G, Gotti F, Maestri R, Bera R, Gargantini R, Bossio F, Zivi I, Volpe D, Ferrazzoli D, Frazzitta G. Land Plus Aquatic Therapy Versus Land-Based Rehabilitation Alone for the Treatment of Balance Dysfunction in Parkinson Disease: A Randomized Controlled Study With 6-Month Follow-Up. Arch Phys Med Rehabil. 2017 Jun;98(6):1077-1085. doi: 10.1016/j.apmr.2017.01.025. Epub 2017 Feb 27.
Results Reference
derived

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

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