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

NCT ID: NCT02701621

Last Updated: 2016-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2014-12-31

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

MIRT

Intervention Type: OTHER

Land-based Therapy

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.

Group Type: EXPERIMENTAL

MIRT-AT

Intervention Type: OTHER

Aquatic therapy

Interventions

MIRT-AT

Aquatic therapy

Intervention Type: OTHER

MIRT

Land-based Therapy

Intervention Type: OTHER

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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ospedale Generale Di Zona Moriggia-Pelascini

OTHER

Sponsor Role: lead

Responsible Party

Ilaria Zivi

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Giuseppe Frazzitta, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Parkinson's Disease and Brain Injury Rehabilitation, of the 'Moriggia-Pelascini' Hospital - Gravedona ed Uniti (CO, Italy)

Locations

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

Gravedona Ed Uniti, Como, Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 28254636 (View on PubMed)

Other Identifiers

ATvsLB Therapy for BD in PD

Identifier Type: -

Identifier Source: org_study_id