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

Primary Purpose

Parkinson Disease, Gait Disorders, Neurologic, Gait Disorder, Sensorimotor

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
MIRT
MIRT-AT
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

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • "Moriggia-Pelascini" Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

MIRT

MIRT-AT

Arm Description

Patients in this group will undergo a 4-week Multidisciplinary Intensive Rehabilitation Treatment (MIRT).

Patients in this group will undergo a 4-week Multidisciplinary Intensive Rehabilitation Treatment associated with Aquatic Therapy (MIRT-AT).

Outcomes

Primary Outcome Measures

Freezing of Gait Questionnaire (FOGQ)
Assess FoG frequency, disturbances in gait and relationship to clinical features conceptually associated with gait and motor aspects.

Secondary Outcome Measures

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

Full Information

First Posted
January 7, 2017
Last Updated
December 27, 2017
Sponsor
Ospedale Generale Di Zona Moriggia-Pelascini
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1. Study Identification

Unique Protocol Identification Number
NCT03015714
Brief Title
Aquatic Therapy for Freezing of Gait in Parkinson's Disease Patients
Acronym
AT-FOG
Official Title
Effectiveness of Aquatic Therapy for Parkinson's Disease Patients in the Context of a Multidisciplinary, Intensive Rehabilitation Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
January 2017 (Actual)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Gait Disorders, Neurologic, Gait Disorder, Sensorimotor

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MIRT
Arm Type
Active Comparator
Arm Description
Patients in this group will undergo a 4-week Multidisciplinary Intensive Rehabilitation Treatment (MIRT).
Arm Title
MIRT-AT
Arm Type
Active Comparator
Arm Description
Patients in this group will undergo a 4-week Multidisciplinary Intensive Rehabilitation Treatment associated with Aquatic Therapy (MIRT-AT).
Intervention Type
Other
Intervention Name(s)
MIRT
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
MIRT-AT
Intervention Description
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 Measure Information:
Title
Freezing of Gait Questionnaire (FOGQ)
Description
Assess FoG frequency, disturbances in gait and relationship to clinical features conceptually associated with gait and motor aspects.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Unified Parkinson's Disease Rating Scale tot (UPDRS tot)
Description
Clinician-scored monitored patient's global evaluation.
Time Frame
4 weeks
Title
Unified Parkinson's Disease Rating Scale Part III (UPDRS III)
Description
UPDRS subpart: clinician-scored monitored patient's motor evaluation
Time Frame
4 weeks
Title
Unified Parkinson's Disease Rating Scale Part II (UPDRS II)
Description
UPDRS subart: clinician-scored monitored patient's activitied daily life evaluation
Time Frame
4 weeks
Title
Berg Balance Scale (BBS)
Description
Motor-functional test for balance evaluation
Time Frame
4 weeks
Title
Timed Up and Go Test (TUG)
Description
Motor-functional test for sit to stand, walking and turning evaluation
Time Frame
4 weeks
Title
Six Minutes Walking Test (6MWT)
Description
Motor-functional test for gait endurance
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giuseppe Frazzitta, MD
Organizational Affiliation
"Moriggia-Pelascini" Hospital
Official's Role
Study Director
Facility Information:
Facility Name
"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
30657995
Citation
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.
Results Reference
derived

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Aquatic Therapy for Freezing of Gait in Parkinson's Disease Patients

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