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Clinical Trials/NCT03015714
NCT03015714CompletedNot Applicable

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

Ospedale Generale Di Zona Moriggia-Pelascini1 site in 1 country30 target enrollmentStarted: January 1, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
30
Locations
1
Primary Endpoint
Freezing of Gait Questionnaire (FOGQ)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
50 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

MIRT

Active Comparator

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

Intervention: MIRT (Other)

MIRT-AT

Active Comparator

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

Intervention: MIRT-AT (Other)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Six Minutes Walking Test (6MWT)(4 weeks)
  • Timed Up and Go Test (TUG)(4 weeks)
  • Unified Parkinson's Disease Rating Scale tot (UPDRS tot)(4 weeks)
  • Unified Parkinson's Disease Rating Scale Part III (UPDRS III)(4 weeks)
  • Unified Parkinson's Disease Rating Scale Part II (UPDRS II)(4 weeks)
  • Berg Balance Scale (BBS)(4 weeks)

Investigators

Sponsor
Ospedale Generale Di Zona Moriggia-Pelascini
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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