An interventional study of Mézières Method and Home based exercise program in Parkinson's Disease, sponsored by University of Roma La Sapienza. Completed at 1 site in Italy. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-07-06.
Sponsored by University of Roma La Sapienza · Not applicable, Interventional, and Treatment
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.
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's enrollment of 36 is close to the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →University of Roma La Sapienza is the lead sponsor of 388 studies on the registry; 55 are open to participants now.
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Exclusion Criteria:
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
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
10 sessions of rehabilitative treatment according to the Mézières Method, 2 sessions per week for 5 weeks, each lasting 1 hour.
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.
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.
Time frame: Baseline, 4 weeks, 12 weeks
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.
Time frame: Baseline, 4 weeks, 12 weeks
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).
Time frame: Baseline, 4 weeks, 12 weeks
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).
Time frame: Baseline, 4 weeks, 12 weeks
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.
Time frame: Baseline, 4 weeks, 12 weeks
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.
Time frame: Baseline, 4 weeks, 12 weeks
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.
Time frame: Baseline, 4 weeks, 12 weeks
This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.
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University of Roma La Sapienza