Parkinson's DiseaseNCT02891473
A Rehabilitative Approach in Patients With Parkinson's Disease
A study testing Mézières Method and Home based exercise program in people with Parkinson's Disease, run by University of Roma La Sapienza at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Mézières Method and Home based exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2015to Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Mézières Rehabilitative Method in Patients With Parkinson's Disease: a Randomized Controlled Trial
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
- Being tested
- Mézières Method, Home based exercise program
- Keywords
- Posture, Pain, Muscle stretching, Mézières method, Camptocormia, Trunk control
- Medical subject headings
- Parkinson Disease, Pain, Camptocormia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mézières MethodOther
10 sessions of rehabilitative treatment according to the Mézières Method, 2 sessions per week for 5 weeks, each lasting 1 hour.
Home based exercise programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Home based exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 4 weeks, 12 weeks
Secondary outcomes (6)
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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 4 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2016 (estimated)
- Study startJul 2015
- Primary completionSep 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Teresa Paolucci, University of Roma La Sapienza
- Investigators
- Vincenzo Maria Saraceni, Study director, Sapienza University of Rome, Policlinico Umberto I hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02891473
- Sponsor's protocol ID
- 2519/15
- Status last verified
- Jul 2017
- First submitted
- 31 Aug 2016
- Last updated
- 6 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Mézières Rehabilitative Method in Patients With Parkinson's Disease: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02891473
- Acronym / sponsor ID
- 2519/15
- Conditions
- Parkinson's Disease
- Keywords
- Posture, Pain, Muscle stretching, Mézières method, Camptocormia, Trunk control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 7 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mézières Method group | Experimental | Other: Mézières MethodSessions 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. |
| Home based exercise program group | Active comparator | Other: Home based exercise programSessions 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. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mézières Method10 sessions of rehabilitative treatment according to the Mézières Method, 2 sessions per week for 5 weeks, each lasting 1 hour. | Other | Mézières Method group |
| Home based exercise program1 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. | Other | Home based exercise program group |
Primary outcome
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.
6 secondary outcomes
Change of Visual Analogue Scale (VAS) from baseline to 12 weeks
Time frame: Baseline, 4 weeks, 12 weeks
Change of Unified Parkinson's Disease Rating Scale (UPDRS) from baseline to 12 weeks
Time frame: Baseline, 4 weeks, 12 weeks
Change of Functional Gait Assessment (FGA) from baseline to 12 weeks
Time frame: Baseline, 4 weeks, 12 weeks
Change of Clinical Evaluation of Posture from baseline to 12 weeks
Time frame: Baseline, 4 weeks, 12 weeks
Change of Modified Parkinson Activity Scale (MPAS) from baseline to 12 weeks
Time frame: Baseline, 4 weeks, 12 weeks
Change of SF-36 Health Survey Questionnaire from baseline to 12 weeks
Time frame: Baseline, 4 weeks, 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vincenzo Maria Saraceni study director
Sapienza University of Rome, Policlinico Umberto I hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mézières Method and Home based exercise program in people with Parkinson's Disease, run by University of Roma La Sapienza at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Berg Balance Scale (BBS) from baseline to 12 weeks (time frame: Baseline, 4 weeks, 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2017.