Impact of Myotensives Techniques, With and Without Auto-reeducation, on the Vital Capacity Forced by the Patient Affected by a Honeymoon Parkinson's Disease
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
with self stretching same muscle
with self stretching of forearm muscles
Sponsored by
About this trial
This is an interventional supportive care trial for Parkinson Disease
Eligibility Criteria
Inclusion Criteria:
- Age >18
- with Parkinson's disease
- stable stade of pathology
- without any treatment modification.
Exclusion Criteria:
- rehabilitation support or osteopathic support
- active smoking
- respiratory disease
- cognitives trouble
- any other neurologic pathology
Sites / Locations
- Groupe Hospitalier Paris Saint Joseph
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
with self stretching same muscle
with self stretching forearm muscle
Arm Description
Outcomes
Primary Outcome Measures
Percentage vital respiratory capacity
Secondary Outcome Measures
Full Information
NCT ID
NCT03313973
First Posted
October 10, 2017
Last Updated
October 18, 2017
Sponsor
Fondation Hôpital Saint-Joseph
1. Study Identification
Unique Protocol Identification Number
NCT03313973
Brief Title
Impact of Myotensives Techniques, With and Without Auto-reeducation, on the Vital Capacity Forced by the Patient Affected by a Honeymoon Parkinson's Disease
Official Title
Impact of Myotensives Techniques, With and Without Auto-reeducation, on the Vital Capacity Forced by the Patient Affected by a Honeymoon Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
December 5, 2016 (Actual)
Primary Completion Date
June 30, 2017 (Actual)
Study Completion Date
July 31, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Hôpital Saint-Joseph
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Lower respiratory tract infections are one of the main hospitalization or mortality cause in idiopathic Parkinson's disease. Because of akinesia and articular rigidity these patient develop restrictive syndrome by reduction in the thoraco-lung compliance.The consequence is a progressive loss of the aerobic physical abilities and infection.
The myotensive technique of active muscular stretching seem to increase the range of motion in healthy subject but also in patient with chronic bronchiotisis . These technics also increase the vital respiratory capacity and re enforce the muscles.So adding these technics during the period when the Parkinson's disease patient is stable would be a way of improvement .
Detailed Description
To validate if these techniques really improve the the vital respiratory capacity, investigators randomize patient in 2 groups; one will have the standard protocol of stretching + self stretching of the same muscles (experimental group) and the other one (control group) will have the standard protocol and self stretching of forearm . Self stretching of forearm is selected to avoid bias .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
with self stretching same muscle
Arm Type
Experimental
Arm Title
with self stretching forearm muscle
Arm Type
Sham Comparator
Intervention Type
Procedure
Intervention Name(s)
with self stretching same muscle
Intervention Description
with self stretching
Intervention Type
Procedure
Intervention Name(s)
with self stretching of forearm muscles
Intervention Description
without self stretching
Primary Outcome Measure Information:
Title
Percentage vital respiratory capacity
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age >18
with Parkinson's disease
stable stade of pathology
without any treatment modification.
Exclusion Criteria:
rehabilitation support or osteopathic support
active smoking
respiratory disease
cognitives trouble
any other neurologic pathology
Facility Information:
Facility Name
Groupe Hospitalier Paris Saint Joseph
City
Paris
State/Province
Ile-de-France
ZIP/Postal Code
75014
Country
France
12. IPD Sharing Statement
Learn more about this trial
Impact of Myotensives Techniques, With and Without Auto-reeducation, on the Vital Capacity Forced by the Patient Affected by a Honeymoon Parkinson's Disease
We'll reach out to this number within 24 hrs