Chest PNF on Pulmonary Function in Parkinson Disease
Primary Purpose
Parkinson Disease
Status
Unknown status
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
chest PNF
Conventional
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease
Eligibility Criteria
Inclusion Criteria:
- Grade 3 to grade 5 Parkinson patients according to Hoehn Yahar scale
- MMSE score >23.
- Age 50-70 yrs.
- Both Male and Female.
Exclusion Criteria:
- Previous history of cardiac and pulmonary surgery.
- History of flail chest.
- Individual affected by neurological disorder other than PD.
- Uncooperative patients.
- Individual with the psychosomatic disorder.
Sites / Locations
- MMIPRRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
chest PNF
Conventional
Arm Description
participants received conventional chest physiotherapy along with chest PNF technique 5 days for 1 week. Chest PNF technique includes oblique downward pressure at the sternum, diagonal pressure at lower rib cage at the supine line, caudal medial pressure at side lying, Caudal pressure at ribcage at prone lying, dorsal and caudal pressure at prone on the elbow.
participants received conventional chest physiotherapy treatment, which includes Deep breathing exercise, Diaphragmatic breathing exercise, segmental breathing exercise and purse lip breathing and incentive spirometer
Outcomes
Primary Outcome Measures
Pulmonary Function Test (PFT)
Pulmonary functions parameters FVC in litre, FEV1 in litre and ratio between FVC/FEV1 will be recorded with PFT
Secondary Outcome Measures
chest wall expansion by inch tape
chest wall expansion will be measured at axillary and xiphisternal level
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03977740
Brief Title
Chest PNF on Pulmonary Function in Parkinson Disease
Official Title
Efficacy of Chest PNF on Pulmonary Function in Patients With Parkinson's Diseases
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
June 10, 2019 (Anticipated)
Study Completion Date
June 10, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Subhasish Chatterjee
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Background: Parkinson disease (PD) is a progressive neurodegenerative disorder and characterized by tremor, rigidity and bradykinesia. Almost 84% of PD patient develops respiratory abnormalities and pointed as the most common cause of death. Airway obstruction, trunk muscle rigidity is the common cause of respiratory abnormalities.
Purpose: The main purpose of the study will evaluate the efficacy of chest PNF on pulmonary function and chest wall mobility in PD.
Methods: 20 participants will be recruited for study purpose and divide into two groups. Group= A will be the control group and participants will receive conventional treatment which includes deep breathing exercise and segmental breathing exercise, incentive spirometry etc for one week. Group= B participants will receive chest PNF exercise along with conventional treatment for a week. Pretreatment and post-treatment data will be recorded by the help of PFT (FVC, FEV1 & FEV1/FVC) and chest wall expansion at axillary and xiphisternal level for data analysis. Data analysis will be done by paired t-test for within group and independent t-test will be used for the between-group variable. The level of significance will be set at 0.05.
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
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
chest PNF
Arm Type
Experimental
Arm Description
participants received conventional chest physiotherapy along with chest PNF technique 5 days for 1 week.
Chest PNF technique includes oblique downward pressure at the sternum, diagonal pressure at lower rib cage at the supine line, caudal medial pressure at side lying, Caudal pressure at ribcage at prone lying, dorsal and caudal pressure at prone on the elbow.
Arm Title
Conventional
Arm Type
Active Comparator
Arm Description
participants received conventional chest physiotherapy treatment, which includes Deep breathing exercise, Diaphragmatic breathing exercise, segmental breathing exercise and purse lip breathing and incentive spirometer
Intervention Type
Other
Intervention Name(s)
chest PNF
Intervention Description
Chest PNF technique includes oblique downward pressure at sternum, diagonal pressure at lower rib cage at supine line, caudal medial pressure at side lying, Caudal pressure at ribcage at prone lying, dorsal and caudal pressure at prone on elbow.
Intervention Type
Other
Intervention Name(s)
Conventional
Intervention Description
conventional chest physiotherapy treatment, which includes Deep breathing exercise, Diaphragmatic breathing exercise, segmental breathing exercise and purse lip breathing and incentive spirometer
Primary Outcome Measure Information:
Title
Pulmonary Function Test (PFT)
Description
Pulmonary functions parameters FVC in litre, FEV1 in litre and ratio between FVC/FEV1 will be recorded with PFT
Time Frame
changes bwtween baseline to 1 week
Secondary Outcome Measure Information:
Title
chest wall expansion by inch tape
Description
chest wall expansion will be measured at axillary and xiphisternal level
Time Frame
changes bwtween baseline to 1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Grade 3 to grade 5 Parkinson patients according to Hoehn Yahar scale
MMSE score >23.
Age 50-70 yrs.
Both Male and Female.
Exclusion Criteria:
Previous history of cardiac and pulmonary surgery.
History of flail chest.
Individual affected by neurological disorder other than PD.
Uncooperative patients.
Individual with the psychosomatic disorder.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mousumi Saha, MPT
Phone
9366787310
Email
msaha0029@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Nidhi Sharma
Phone
7906134419
Facility Information:
Facility Name
MMIPR
City
Ambāla
State/Province
Haryana
ZIP/Postal Code
133207
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mousumi Saha, MPT
Email
msaha0029@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Chest PNF on Pulmonary Function in Parkinson Disease
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