Aquatic Therapy for Freezing of Gait in Parkinson's Disease Patients (AT-FOG)
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|ClinicalTrials.gov Identifier: NCT03015714|
Recruitment Status : Completed
First Posted : January 10, 2017
Last Update Posted : December 28, 2017
|Condition or disease||Intervention/treatment||Phase|
|Parkinson Disease Gait Disorders, Neurologic Gait Disorder, Sensorimotor||Other: MIRT Other: MIRT-AT||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
Active Comparator: MIRT
Patients in this group will undergo a 4-week Multidisciplinary Intensive Rehabilitation Treatment (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).
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.
- 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.
- Unified Parkinson's Disease Rating Scale tot (UPDRS tot) [ Time Frame: 4 weeks ]Clinician-scored monitored patient's global evaluation.
- Unified Parkinson's Disease Rating Scale Part III (UPDRS III) [ Time Frame: 4 weeks ]UPDRS subpart: clinician-scored monitored patient's motor evaluation
- 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
- Berg Balance Scale (BBS) [ Time Frame: 4 weeks ]Motor-functional test for balance evaluation
- Timed Up and Go Test (TUG) [ Time Frame: 4 weeks ]Motor-functional test for sit to stand, walking and turning evaluation
- Six Minutes Walking Test (6MWT) [ Time Frame: 4 weeks ]Motor-functional test for gait endurance
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 ClinicalTrials.gov identifier (NCT number): NCT03015714
|Gravedona Ed Uniti, Como, Italy, 22015|
|Study Director:||Giuseppe Frazzitta, MD||"Moriggia-Pelascini" Hospital|