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

Parkinson Disease Clinical Trial

— AT-FOG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03015714
• Other study ID #: "Moriggia-Pelascini" Hospital
• Status: Completed
• Phase: N/A
• First received: January 7, 2017
• Last updated: December 27, 2017
• Start date: January 2017
• Est. completion date: June 2017

Study information

• Verified date: December 2017
• Source: Ospedale Generale Di Zona Moriggia-Pelascini
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Gait Disorder, Sensorimotor
• Gait Disorders, Neurologic
• Nervous System Diseases
• Parkinson Disease

Intervention

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.
• 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.

Locations

Country	Name	City	State
Italy	"Moriggia-Pelascini" Hospital	Gravedona Ed Uniti	Como

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale Generale Di Zona Moriggia-Pelascini

Country where clinical trial is conducted

Italy, 

Outcome

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