A Rehabilitative Approach in Patients With Parkinson's Disease

Parkinson's Disease Clinical Trial

Official title:

Impact of Mézières Rehabilitative Method in Patients With Parkinson's Disease: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02891473
• Other study ID #: 2519/15
• Status: Completed
• Phase: N/A
• First received: August 31, 2016
• Last updated: July 3, 2017
• Start date: July 2015
• Est. completion date: January 2016

Study information

• Verified date: July 2017
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: January 2016
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Other:
• Mézières Method
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
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.

Locations

Country	Name	City	State
Italy	Umberto I Hospital	Rome

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change of Visual Analogue Scale (VAS) from baseline to 12 weeks	It is a scale for the assessment of pain and it's based on a ten point scale, where 0 means no pain and 10 the greatest pain ever both at rest and during movements.	Baseline, 4 weeks, 12 weeks
Secondary	Change of Unified Parkinson's Disease Rating Scale (UPDRS) from baseline to 12 weeks	It consists of six parts made up of questions about the mental state, behavior and mood, ADL, motor functions, the complications of the advanced disease, the stage of the disease identified by the Hoehen and Yahr scale and the modification in the execution of the ADL trough the scale of Schwab and England. The scale is based on a metric scale from 0 (no disability) to 147 points (severe disability).	Baseline, 4 weeks, 12 weeks
Secondary	Change of Functional Gait Assessment (FGA) from baseline to 12 weeks	It is a 10-items scale that measures walking balance activity and it was developed from the Dynamic Gait Index (DGI) to improve reliability and decrease the ceiling effect. Each item is scored on a 3 point-scale from 0 (severe impairment) to 3 (normal deambulation). The highest possible score is 30 (normal gait function).	Baseline, 4 weeks, 12 weeks
Secondary	Change of Clinical Evaluation of Posture from baseline to 12 weeks	It is the evaluation of the anterior flexion of the trunk by measuring the distance fingers-floor.	Baseline, 4 weeks, 12 weeks
Secondary	Change of Modified Parkinson Activity Scale (MPAS) from baseline to 12 weeks	consists of 14 items arranged into three domains, chair transfer, gait akinesia and bed mobility. Scores range from 0 (dependent) to 4 (normal) and the total possible score is 56.	Baseline, 4 weeks, 12 weeks
Secondary	Change of SF-36 Health Survey Questionnaire from baseline to 12 weeks	It is a multi-dimensional questionnaire for the evaluation of health status. It is divided into eight sub-categories that measure physical activity, limitations due to physical health and emotional state, physical pain, the perception of general health, vitality, social activities, mental health and changes in health status and two indices that summarize the overall assessment of the subject with respect to his/her physical (ISF) and mental (ISM) health.	Baseline, 4 weeks, 12 weeks