Clinical trial NCT03015714: Aquatic Therapy for Freezing of Gait in Parkinson's Disease Patients
Official title: Effectiveness of Aquatic Therapy for Parkinson's Disease Patients in the Context of a Multidisciplinary, Intensive Rehabilitation Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Gait Disorders, Neurologic
Gait Disorder, Sensorimotor
Lead sponsor: Ospedale Generale Di Zona Moriggia-Pelascini
Sponsor class: OTHER
First posted: 2017-01-10
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Freezing of Gait Questionnaire (FOGQ)
timeFrame: 4 weeks
Secondary outcomes:
measure: Unified Parkinson's Disease Rating Scale tot (UPDRS tot)
timeFrame: 4 weeks
measure: Unified Parkinson's Disease Rating Scale Part III (UPDRS III)
timeFrame: 4 weeks
measure: Unified Parkinson's Disease Rating Scale Part II (UPDRS II)
timeFrame: 4 weeks
measure: Berg Balance Scale (BBS)
timeFrame: 4 weeks
measure: Timed Up and Go Test (TUG)
timeFrame: 4 weeks
measure: Six Minutes Walking Test (6MWT)
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Gravedona Ed Uniti
country: Italy
facility: "Moriggia-Pelascini" Hospital
state: Como
Study officials:
affiliation: "Moriggia-Pelascini" Hospital
name: Giuseppe Frazzitta, MD
role: STUDY_DIRECTOR
References:
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.