A Rehabilitative Approach in Patients With Parkinson's Disease

NCT02891473 | Completed DMC

• 1 other identifier: 2519/15
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Keywords

Posture; Pain; Muscle stretching; Mézières method; Camptocormia; Trunk control

Outcome Measures

Primary Outcomes (1)

• Change of Berg Balance Scale (BBS) from baseline to 12 weeks

  It is a widely used clinical tests to evaluate static and dynamic balance of a subject. The total score is 56 (\> 45 safe walking without aids/low tendency to fall, \> 35 safe walking with aids). The test lasts 15-20 minutes, and includes 14 simple tasks. The success in achieving each task is evaluated assigned a score from zero (dependent) to four (independent), and the final measure is the sum of all scores. The scale is considered the gold standard for providing useful information on the predictive estimation of the risk of falls.

  Baseline, 4 weeks, 12 weeks

Secondary Outcomes (6)

• Change of Visual Analogue Scale (VAS) from baseline to 12 weeks

  Baseline, 4 weeks, 12 weeks

• Change of Unified Parkinson's Disease Rating Scale (UPDRS) from baseline to 12 weeks

  Baseline, 4 weeks, 12 weeks

• Change of Functional Gait Assessment (FGA) from baseline to 12 weeks

  Baseline, 4 weeks, 12 weeks

• Change of Clinical Evaluation of Posture from baseline to 12 weeks

  Baseline, 4 weeks, 12 weeks

• Change of Modified Parkinson Activity Scale (MPAS) from baseline to 12 weeks

  Baseline, 4 weeks, 12 weeks

Study Arms (2)

Mézières Method group

EXPERIMENTAL

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.

Other: Mézières Method

Home based exercise program group

ACTIVE COMPARATOR

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.

Other: Home based exercise program

Interventions

Mézières Method OTHER

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

Mézières Method group

Home based exercise program 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.

Home based exercise program group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

Umberto I Hospital

Rome, 00165, Italy

Location

MeSH Terms

Conditions

Parkinson Disease; Pain; Camptocormia

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

• Vincenzo Maria Saraceni

  Sapienza University of Rome, Policlinico Umberto I hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director

Study Record Dates

• First Submitted: August 31, 2016
• First Posted: September 7, 2016
• Study Start: July 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: January 1, 2016
• Last Updated: July 6, 2017

Record last verified: 2017-07

Locations

IT (1)