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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03015714
Recruitment Status : Completed
First Posted : January 10, 2017
Last Update Posted : December 28, 2017
Information provided by (Responsible Party):
Ospedale Generale Di Zona Moriggia-Pelascini

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Gait Disorders, Neurologic Gait Disorder, Sensorimotor Other: MIRT Other: MIRT-AT Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Aquatic Therapy for Parkinson's Disease Patients in the Context of a Multidisciplinary, Intensive Rehabilitation Treatment
Actual Study Start Date : January 2017
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

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.

Primary Outcome Measures :
  1. Freezing of Gait Questionnaire (FOGQ) [ Time Frame: 4 weeks ]
    Assess FoG frequency, disturbances in gait and relationship to clinical features conceptually associated with gait and motor aspects.

Secondary Outcome Measures :
  1. Unified Parkinson's Disease Rating Scale tot (UPDRS tot) [ Time Frame: 4 weeks ]
    Clinician-scored monitored patient's global evaluation.

  2. Unified Parkinson's Disease Rating Scale Part III (UPDRS III) [ Time Frame: 4 weeks ]
    UPDRS subpart: clinician-scored monitored patient's motor evaluation

  3. Unified Parkinson's Disease Rating Scale Part II (UPDRS II) [ Time Frame: 4 weeks ]
    UPDRS subart: clinician-scored monitored patient's activitied daily life evaluation

  4. Berg Balance Scale (BBS) [ Time Frame: 4 weeks ]
    Motor-functional test for balance evaluation

  5. Timed Up and Go Test (TUG) [ Time Frame: 4 weeks ]
    Motor-functional test for sit to stand, walking and turning evaluation

  6. Six Minutes Walking Test (6MWT) [ Time Frame: 4 weeks ]
    Motor-functional test for gait endurance

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03015714

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"Moriggia-Pelascini" Hospital
Gravedona Ed Uniti, Como, Italy, 22015
Sponsors and Collaborators
Ospedale Generale Di Zona Moriggia-Pelascini
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Study Director: Giuseppe Frazzitta, MD "Moriggia-Pelascini" Hospital
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Ospedale Generale Di Zona Moriggia-Pelascini Identifier: NCT03015714    
Other Study ID Numbers: "Moriggia-Pelascini" Hospital
First Posted: January 10, 2017    Key Record Dates
Last Update Posted: December 28, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Parkinson Disease
Nervous System Diseases
Gait Disorders, Neurologic
Pathologic Processes
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Neurologic Manifestations