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出境医 / 临床实验 / Chest PNF on Pulmonary Function in Parkinson Disease

Chest PNF on Pulmonary Function in Parkinson Disease

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.


Condition or disease Intervention/treatment Phase
Parkinson Disease Other: chest PNF Other: Conventional Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Chest PNF on Pulmonary Function in Patients With Parkinson's Diseases
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : June 10, 2019
Estimated Study Completion Date : June 10, 2019
Arms and Interventions
Arm Intervention/treatment
Experimental: chest PNF

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.

 Other: chest PNF
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.
Active Comparator: Conventional
participants received conventional chest physiotherapy treatment, which includes Deep breathing exercise, Diaphragmatic breathing exercise, segmental breathing exercise and purse lip breathing and incentive spirometer
 Other: Conventional
conventional chest physiotherapy treatment, which includes Deep breathing exercise, Diaphragmatic breathing exercise, segmental breathing exercise and purse lip breathing and incentive spirometer
Outcome Measures
Primary Outcome Measures :
  1. Pulmonary Function Test (PFT) [ Time Frame: changes bwtween baseline to 1 week ]
    Pulmonary functions parameters FVC in litre, FEV1 in litre and ratio between FVC/FEV1 will be recorded with PFT


Secondary Outcome Measures :
  1. chest wall expansion by inch tape [ Time Frame: changes bwtween baseline to 1 week ]
    chest wall expansion will be measured at axillary and xiphisternal level


Eligibility Criteria
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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Grade 3 to grade 5 Parkinson patients according to Hoehn Yahar scale
  2. MMSE score >23.
  3. Age 50-70 yrs.
  4. Both Male and Female.

Exclusion Criteria:

  1. Previous history of cardiac and pulmonary surgery.
  2. History of flail chest.
  3. Individual affected by neurological disorder other than PD.
  4. Uncooperative patients.
  5. Individual with the psychosomatic disorder.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Mousumi Saha, MPT 9366787310 msaha0029@gmail.com
Contact: Nidhi Sharma 7906134419

Locations
Layout table for location information
India
MMIPR Recruiting
Ambāla, Haryana, India, 133207
Contact: Mousumi Saha, MPT       msaha0029@gmail.com   
Sponsors and Collaborators
Subhasish Chatterjee
Tracking Information
First Submitted Date  ICMJE May 27, 2019
First Posted Date  ICMJE June 6, 2019
Last Update Posted Date June 6, 2019
Actual Study Start Date  ICMJE January 1, 2018
Estimated Primary Completion Date June 10, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 5, 2019) 		Pulmonary Function Test (PFT) [ Time Frame: changes bwtween baseline to 1 week ]
Pulmonary functions parameters FVC in litre, FEV1 in litre and ratio between FVC/FEV1 will be recorded with PFT
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 5, 2019) 		chest wall expansion by inch tape [ Time Frame: changes bwtween baseline to 1 week ]
chest wall expansion will be measured at axillary and xiphisternal level
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Chest PNF on Pulmonary Function in Parkinson Disease
Official Title  ICMJE Efficacy of Chest PNF on Pulmonary Function in Patients With Parkinson's Diseases
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Parkinson Disease
Intervention  ICMJE
  • Other: chest PNF
    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.
  • Other: Conventional
    conventional chest physiotherapy treatment, which includes Deep breathing exercise, Diaphragmatic breathing exercise, segmental breathing exercise and purse lip breathing and incentive spirometer
Study Arms  ICMJE
  • Experimental: chest PNF

    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.

    Intervention: Other: chest PNF
  • Active Comparator: Conventional
    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: Other: Conventional
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 5, 2019) 		20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 10, 2019
Estimated Primary Completion Date June 10, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Grade 3 to grade 5 Parkinson patients according to Hoehn Yahar scale
  2. MMSE score >23.
  3. Age 50-70 yrs.
  4. Both Male and Female.

Exclusion Criteria:

  1. Previous history of cardiac and pulmonary surgery.
  2. History of flail chest.
  3. Individual affected by neurological disorder other than PD.
  4. Uncooperative patients.
  5. Individual with the psychosomatic disorder.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03977740
Other Study ID Numbers  ICMJE IEC-1111
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Subhasish Chatterjee, Maharishi Markendeswar University (Deemed to be University)
Study Sponsor  ICMJE Subhasish Chatterjee
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Maharishi Markendeswar University (Deemed to be University)
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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