Aquatic Therapy for Freezing of Gait in Parkinson's Disease Patients (AT-FOG)

Effectiveness of Aquatic Therapy for Parkinson's Disease Patients in the Context of a Multidisciplinary, Intensive Rehabilitation Treatment

Evaluation of the effectiveness of aquatic therapy for the treatment of freezing of gait in Parkinson's disease patients undergoing a multidisciplinary and intensive rehabilitation treatment.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease; Gait Disorders, Neurologic; Gait Disorder, Sensorimotor
• Intervention / Treatment: Other: MIRT; Other: MIRT-AT

Detailed Description

Freezing of gait (FoG) is an often dramatic, disabling episodic gait pattern that is common in Parkinson's disease (PD). FoG highly impairs mobility, causes falls, and reduces quality of life. Given the limited effectiveness of both the dopaminergic therapy and the deep brain stimulation on this symptom, it represents a challenge in the field of rehabilitation. In the last years, some studies described the effectiveness of aquatic therapy on balance dysfunction in patients with PD, correlating it to the safe conditions offered by the aquatic environment and to the physical properties of water. Nevertheless, the issues concerning the feasibility and the effectiveness of aquatic therapy for the treatment of FoG have never been addressed before. The aquatic environment may act on the sensorial peripheral receptors, thus widely stimulating the proprioceptive system. PD patients show an altered processing of the proprioceptive information that could potentially underline FoG. The investigators aim at investigating the effects of aquatic therapy for the treatment of FoG in PD patients undergoing a Multidisciplinary Intensive Rehabilitation Treatment (MIRT), whose effectiveness on several motor and functional parameters has been already demonstrated.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Como
    • Gravedona Ed Uniti, Como, Italy, 22015
      • "Moriggia-Pelascini" Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diagnosis of PD according to Gelb et al;
• Hoehn & Yahr (H&Y) stage 2.5-3;
• Presence of FOG confirmed in the patient assessment prior to participation in the study;
• Stable pharmacological treatment for the last 8 weeks and during the rehabilitation period;
• Mini Mental State Examination (MMSE) ≥ 24;

Exclusion Criteria:

• Cardiac, pulmonary, vestibular and orthopedic diseases;
• Urinary incontinence;
• Severe dyskinesias;
• Patients treated with deep brain stimulation;
• Visual deficits;
• Comorbilities other than PD determining reduction of motor autonomy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: MIRT; Patients in this group will undergo a 4-week Multidisciplinary Intensive Rehabilitation Treatment (MIRT).	Other: MIRT; MIRT consists of a 4-week rehabilitation program in a hospital setting, which entails four daily sessions of physical therapy for five days and one hour of physical exercise on the sixth day. On the seventh day the patient rests. The duration of each session, including recovery periods, is about one hour. The first session consists of a one-to-one session with a physical therapist. The second session includes aerobic exercises to improve balance and gait, using different devices: a stabilometric platform with visual cues, a treadmill plus and a cycloergometer. The third session consists of occupational therapy, the fourth one includes one hour of speech therapy.
Active Comparator: MIRT-AT; Patients in this group will undergo a 4-week Multidisciplinary Intensive Rehabilitation Treatment associated with Aquatic Therapy (MIRT-AT).	Other: MIRT-AT; Patients in the MIRT-AT group will undergo the land-based therapy described in MIRT plus three sessions per week (Monday, Wednesday, Friday) of aquatic therapy. On days of aquatic therapy the first session of MIRT was not provided. The aquatic therapy program included aerobic exercises and physical activities to improve balance, motor skills, coordination and joints mobility. The water sessions were divided into 3 phases: i) Warm Up Exercises, ii) Central session Training, iii) Cool-down.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freezing of Gait Questionnaire (FOGQ)	Assess FoG frequency, disturbances in gait and relationship to clinical features conceptually associated with gait and motor aspects.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Unified Parkinson's Disease Rating Scale tot (UPDRS tot)	Clinician-scored monitored patient's global evaluation.	4 weeks
Unified Parkinson's Disease Rating Scale Part III (UPDRS III)	UPDRS subpart: clinician-scored monitored patient's motor evaluation	4 weeks
Unified Parkinson's Disease Rating Scale Part II (UPDRS II)	UPDRS subart: clinician-scored monitored patient's activitied daily life evaluation	4 weeks
Berg Balance Scale (BBS)	Motor-functional test for balance evaluation	4 weeks
Timed Up and Go Test (TUG)	Motor-functional test for sit to stand, walking and turning evaluation	4 weeks
Six Minutes Walking Test (6MWT)	Motor-functional test for gait endurance	4 weeks

Collaborators and Investigators

• Sponsor: Ospedale Generale Di Zona Moriggia-Pelascini
• Investigators: Study Director: Giuseppe Frazzitta, MD, "Moriggia-Pelascini" Hospital

Publications and helpful links

General Publications

• Clerici I, Maestri R, Bonetti F, Ortelli P, Volpe D, Ferrazzoli D, Frazzitta G. Land Plus Aquatic Therapy Versus Land-Based Rehabilitation Alone for the Treatment of Freezing of Gait in Parkinson Disease: A Randomized Controlled Trial. Phys Ther. 2019 May 1;99(5):591-600. doi: 10.1093/ptj/pzz003.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: January 7, 2017
• First Submitted That Met QC Criteria: January 7, 2017
• First Posted (Estimate): January 10, 2017

Study Record Updates

• Last Update Posted (Actual): December 28, 2017
• Last Update Submitted That Met QC Criteria: December 27, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Neurologic Manifestations; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Disease; Parkinson Disease; Nervous System Diseases; Gait Disorders, Neurologic
• Other Study ID Numbers: "Moriggia-Pelascini" Hospital

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO