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

NCT02701621 | Completed

• 1 other identifier: ATvsLB Therapy for BD in PD
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

Parkinson's disease, aquatic therapy, balance, MIRT

Outcome Measures

Primary Outcomes (1)

• Berg Balance Scale

  6 months

Secondary Outcomes (3)

• TUG

  6 months

• Unified Parkinson's Disease Rating Scale II

  6 months

• Unified Parkinson's Disease Rating Scale III

  6 months

Study Arms (2)

MIRT Group

ACTIVE COMPARATOR

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.

Other: MIRT

MIRT-AT

EXPERIMENTAL

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.

Other: MIRT-AT

Interventions

MIRT-AT OTHER

Aquatic therapy

MIRT-AT

MIRT OTHER

Land-based Therapy

MIRT Group

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Cardiac and pulmonary diseases
• Urinary incontinence
• History of deep brain stimulation

Sponsors & Collaborators

• Ospedale Generale Di Zona Moriggia-Pelascini: lead

Study Sites (1)

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

Gravedona Ed Uniti, Como, 22015, Italy

Location

Related Publications (1)

• 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.

  PMID: 28254636 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Giuseppe Frazzitta, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 29, 2016
• First Posted: March 8, 2016
• Study Start: September 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: March 8, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)