A Rehabilitative Approach in Patients With Parkinson's Disease

NCT ID: NCT02891473

Last Updated: 2017-07-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2016-01-31

Brief Summary

The purpose of the study is to evaluate the effectiveness of a rehabilitative approach using breathing and relaxation techniques, and specifically the elongation of the latissimus dorsi muscle according to the Mézières Method to improve balance and posture and relief pain in patients with Parkinson's disease.

Conditions

Parkinson's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Mézières Method group

Sessions of exercises for the recovery of midline symmetry, diaphragmatic breathing exercises, stretching of the latissimus dorsi respecting the global elongation according to the Mézières Method.

Group Type: EXPERIMENTAL

Mézières Method

Intervention Type: OTHER

10 sessions of rehabilitative treatment according to the Mézières Method, 2 sessions per week for 5 weeks, each lasting 1 hour.

Home based exercise program group

Sessions of home based exercises performed by the patients at their domicile after a training session about the exercise program made by a physiotherapy. The exercises aimed at promoting trunk control in static and dynamic position according to the specific guidelines for Parkinson's disease and proprioceptive exercises for the recovery of balance. An illustrated exercises booklet was given to the patient.

Group Type: ACTIVE_COMPARATOR

Home based exercise program

Intervention Type: OTHER

1 single training session lasting 1 hour for the explication of the rehabilitation program that the patient has to perform independently at home followed by 2 sessions of home based exercises per week for 5 weeks, each lasting 1 hour.

Interventions

Mézières Method

10 sessions of rehabilitative treatment according to the Mézières Method, 2 sessions per week for 5 weeks, each lasting 1 hour.

Intervention Type: OTHER

Home based exercise program

1 single training session lasting 1 hour for the explication of the rehabilitation program that the patient has to perform independently at home followed by 2 sessions of home based exercises per week for 5 weeks, each lasting 1 hour.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Diagnosis od idiopathic Parkinson's disease (according to UK Brain Bank Criteria), Hoehn-Yahr stage ≤3 (determined during "on phase"), Mini Mental State Examination (MMSE) > or = 27, no rehabilitation treatment carried out within 3 months prior to the study, diagnosis of Parkinson's disease by at least 5 years.

Exclusion Criteria

• Dyskinesias
• Severe fluctuations "on-off"
• Modifications of anti-Parkinsonian drug therapy during the three months prior to the start of the study)
• Sensitivity deficit of the trunk or lower extremities (physical examination)
• Vestibular disorders or paroxysmal vertigo
• Previous thoracic or abdominal surgery
• Other neurological or orthopedic conditions involving the trunk or lower extremities (musculoskeletal diseases, severe osteoarthritis, peripheral neuropathy, prosthetic surgery)
• Cardiovascular comorbidities (recent myocardial infarction, heart failure, uncontrolled hypertension, orthostatic hypotension)

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Roma La Sapienza

OTHER

Sponsor Role: lead

Responsible Party

Teresa Paolucci

Medical Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vincenzo Maria Saraceni

Role: STUDY_DIRECTOR

Sapienza University of Rome, Policlinico Umberto I hospital

Locations

Umberto I Hospital

Rome, , Italy

Countries

Italy

Other Identifiers

2519/15

Identifier Type: -

Identifier Source: org_study_id