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

Sponsor

Ospedale Generale Di Zona Moriggia-Pelascini (Other)

Overall Status

Completed

CT.gov ID

NCT03015714

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease Gait Disorders, Neurologic Gait Disorder, Sensorimotor	Other: MIRT Other: MIRT-AT	N/A

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.

Study Design

Study Type:

Interventional

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 :

Jan 1, 2017

Actual Primary Completion Date :

Jun 1, 2017

Actual Study Completion Date :

Jun 1, 2017

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Freezing of Gait Questionnaire (FOGQ) [4 weeks]
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) [4 weeks]
Clinician-scored monitored patient's global evaluation.
Unified Parkinson's Disease Rating Scale Part III (UPDRS III) [4 weeks]
UPDRS subpart: clinician-scored monitored patient's motor evaluation
Unified Parkinson's Disease Rating Scale Part II (UPDRS II) [4 weeks]
UPDRS subart: clinician-scored monitored patient's activitied daily life evaluation
Berg Balance Scale (BBS) [4 weeks]
Motor-functional test for balance evaluation
Timed Up and Go Test (TUG) [4 weeks]
Motor-functional test for sit to stand, walking and turning evaluation
Six Minutes Walking Test (6MWT) [4 weeks]
Motor-functional test for gait endurance

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 85 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	"Moriggia-Pelascini" Hospital	Gravedona Ed Uniti	Como	Italy	22015

Sponsors and Collaborators

Ospedale Generale Di Zona Moriggia-Pelascini

Investigators

Study Director: Giuseppe Frazzitta, MD, "Moriggia-Pelascini" Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ospedale Generale Di Zona Moriggia-Pelascini

ClinicalTrials.gov Identifier:

NCT03015714

Other Study ID Numbers:

"Moriggia-Pelascini" Hospital

First Posted:

Jan 10, 2017

Last Update Posted:

Dec 28, 2017

Last Verified:

Dec 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Parkinson Disease

Nervous System Diseases

Gait Disorders, Neurologic

Disease

Study Results

No Results Posted as of Dec 28, 2017