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Completed

NCT Number: NCT02891473

A Rehabilitative Approach in Patients With Parkinson's Disease

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.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Camptocormia Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Neurologic Manifestations Pain Parkinson Disease Parkinsonian Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Synucleinopathies

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Umberto I Hospital

Rome, 00165, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Mézières Method

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

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.

Primary outcomes

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

    Time frame: Baseline, 4 weeks, 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 outcomes

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

    Time frame: Baseline, 4 weeks, 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.

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

    Time frame: Baseline, 4 weeks, 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).

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

    Time frame: Baseline, 4 weeks, 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).

  4. Change of Clinical Evaluation of Posture from baseline to 12 weeks

    Time frame: Baseline, 4 weeks, 12 weeks

    It is the evaluation of the anterior flexion of the trunk by measuring the distance fingers-floor.

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

    Time frame: Baseline, 4 weeks, 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.

  6. Change of SF-36 Health Survey Questionnaire from baseline to 12 weeks

    Time frame: Baseline, 4 weeks, 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.

Sponsors and collaborators

Lead sponsor

University of Roma La Sapienza

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Sep 7, 2016
Registry last updated
Jul 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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