Back to resultsA Rehabilitative Approach in Patients With Parkinson's Disease
Primary Purpose
Parkinson's Disease
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Mézières Method
Home based exercise program
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring Posture, Pain, Muscle stretching, Mézières method, Camptocormia, Trunk control
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)
Sites / Locations
- Umberto I Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Mézières Method group
Home based exercise program group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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).
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).
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.
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.
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.
Full Information
NCT ID
NCT02891473
First Posted
August 31, 2016
Last Updated
July 3, 2017
Sponsor
University of Roma La Sapienza
1. Study Identification
Unique Protocol Identification Number
NCT02891473
Brief Title
A Rehabilitative Approach in Patients With Parkinson's Disease
Official Title
Impact of Mézières Rehabilitative Method in Patients With Parkinson's Disease: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Roma La Sapienza
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Posture, Pain, Muscle stretching, Mézières method, Camptocormia, Trunk control
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mézières Method group
Arm Type
Experimental
Arm Description
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.
Arm Title
Home based exercise program group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Mézières Method
Intervention Description
10 sessions of rehabilitative treatment according to the Mézières Method, 2 sessions per week for 5 weeks, each lasting 1 hour.
Intervention Type
Other
Intervention Name(s)
Home based exercise program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of Berg Balance Scale (BBS) from baseline to 12 weeks
Description
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.
Time Frame
Baseline, 4 weeks, 12 weeks
Secondary Outcome Measure Information:
Title
Change of Visual Analogue Scale (VAS) from baseline to 12 weeks
Description
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.
Time Frame
Baseline, 4 weeks, 12 weeks
Title
Change of Unified Parkinson's Disease Rating Scale (UPDRS) from baseline to 12 weeks
Description
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).
Time Frame
Baseline, 4 weeks, 12 weeks
Title
Change of Functional Gait Assessment (FGA) from baseline to 12 weeks
Description
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).
Time Frame
Baseline, 4 weeks, 12 weeks
Title
Change of Clinical Evaluation of Posture from baseline to 12 weeks
Description
It is the evaluation of the anterior flexion of the trunk by measuring the distance fingers-floor.
Time Frame
Baseline, 4 weeks, 12 weeks
Title
Change of Modified Parkinson Activity Scale (MPAS) from baseline to 12 weeks
Description
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.
Time Frame
Baseline, 4 weeks, 12 weeks
Title
Change of SF-36 Health Survey Questionnaire from baseline to 12 weeks
Description
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.
Time Frame
Baseline, 4 weeks, 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vincenzo Maria Saraceni
Organizational Affiliation
Sapienza University of Rome, Policlinico Umberto I hospital
Official's Role
Study Director
Facility Information:
Facility Name
Umberto I Hospital
City
Rome
ZIP/Postal Code
00165
Country
Italy
12. IPD Sharing Statement
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A Rehabilitative Approach in Patients With Parkinson's Disease
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