NCT03977740

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for not_applicable parkinson-disease

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 27, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 6, 2019

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2019

Completed
Last Updated

June 6, 2019

Status Verified

June 1, 2019

Enrollment Period

1.4 years

First QC Date

May 27, 2019

Last Update Submit

June 5, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pulmonary Function Test (PFT)

    Pulmonary functions parameters FVC in litre, FEV1 in litre and ratio between FVC/FEV1 will be recorded with PFT

    changes bwtween baseline to 1 week

Secondary Outcomes (1)

  • chest wall expansion by inch tape

    changes bwtween baseline to 1 week

Study Arms (2)

chest PNF

EXPERIMENTAL

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

Conventional

ACTIVE COMPARATOR

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

Interventions

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.

chest PNF

conventional chest physiotherapy treatment, which includes Deep breathing exercise, Diaphragmatic breathing exercise, segmental breathing exercise and purse lip breathing and incentive spirometer

Conventional

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MMIPR

Ambāla, Haryana, 133207, India

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Interventions

Congresses as Topic

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

OrganizationsHealth Care Economics and Organizations

Central Study Contacts

Mousumi Saha, MPT

CONTACT

Nidhi Sharma

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
clinical professor

Study Record Dates

First Submitted

May 27, 2019

First Posted

June 6, 2019

Study Start

January 1, 2018

Primary Completion

June 10, 2019

Study Completion

June 10, 2019

Last Updated

June 6, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations