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

NCT03015714 | Completed

• 1 other identifier: "Moriggia-Pelascini" Hospital
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease; Gait Disorders, Neurologic; Gait Disorder, Sensorimotor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

• Timed Up and Go Test (TUG)

  4 weeks

Study Arms (2)

MIRT

ACTIVE COMPARATOR

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

Other: MIRT

MIRT-AT

ACTIVE COMPARATOR

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

Other: MIRT-AT

Interventions

MIRT OTHER

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

MIRT-AT OTHER

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.

MIRT-AT

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• Ospedale Generale Di Zona Moriggia-Pelascini: lead

Study Sites (1)

"Moriggia-Pelascini" Hospital

Gravedona Ed Uniti, Como, 22015, Italy

Location

Related Publications (1)

• 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.

  PMID: 30657995 DERIVED

MeSH Terms

Conditions

Parkinson Disease; Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Giuseppe Frazzitta, MD

  "Moriggia-Pelascini" Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2017
• First Posted: January 10, 2017
• Study Start: January 1, 2017
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: December 28, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)