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The Effects of Thoracic Joint Mobilization on Pulmonary Functions of Patients With Stroke

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Pulmonary Function Test group
Control Group
Sponsored by
Shehla Gul
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Pulmonary Functions, Stroke

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • A sample of 26 patients with stroke without any history of recent pulmonary involvement
  • Diagnosed with stroke by computed tomography (CT) or magnetic resonance imaging (MRI), with disease duration of at least six months after the onset of stoke.
  • Score 24 points or higher on MMSE to ensure that they able to understand and follows the researcher's order.

Exclusion Criteria:

  • The subjects having any recent surgery,
  • unstable blood pressure and
  • having acute infections were excluded from the study.

Sites / Locations

  • Shehla Gul

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

PULMONARY FUNCTION TEST (PFT) GROUP

Control Group

Arm Description

Thoracic joint Mobilization was applied on Experimental group. Thoracic Flexion: Patient sits on the treatment table with arms across the chest and hands on opposite shoulders. Stand facing the patient's left side. Thoracic Extension: Performed by asking sits on a treatment chair with arms folded across the chest and hands on opposite shoulders. Thoracic Segment Rotation: Performed by asking the patient to lie on left side. Place a pillow under patient's waist to assist left side bending. Position the patient's arms are folded across the chest with hands on opposite shoulders to stabilize the shoulder girdle and minimize movement there.

received conventional Chest physiotherapy Techniques for 30 minutes (including deep breathing, diaphragmatic breathing exercises, Self-stretching exercises for accessory respiratory muscles, Respiratory Resistance training by incentive spirometer) followed by 10 min rest.

Outcomes

Primary Outcome Measures

Forced expiratory Volume in one sec (FEV1)
Pulmonary Functions: Forced expiratory Volume in one sec (FEV1) was measured in litre/sec through digital spirometer
Forced vital capacity (FVC)
Pulmonary Functions: Forced vital capacity (FVC) was measured in litre through digital spirometer

Secondary Outcome Measures

Full Information

First Posted
August 26, 2019
Last Updated
December 10, 2019
Sponsor
Shehla Gul
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1. Study Identification

Unique Protocol Identification Number
NCT04188496
Brief Title
The Effects of Thoracic Joint Mobilization on Pulmonary Functions of Patients With Stroke
Official Title
The Effects of Thoracic Joint Mobilization on Pulmonary Functions of Patients With Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
February 1, 2016 (Actual)
Primary Completion Date
July 31, 2016 (Actual)
Study Completion Date
July 31, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Shehla Gul

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Stroke a neurological disorder leads to long term disability and decline in overall quality of life. Pulmonary Functions are usually impaired in individuals with stroke. The common findings associated with pulmonary functions in Stroke patients are Decreased lung volumes, decreased pulmonary perfusion and vital capacity and altered chest wall excursion. For stroke patients, general rehabilitation programs, only aims towards their functional recovery of the body. The main focus of this study was to integrate intervention and implement them in rehabilitation programs that are related to respiration are more effective for improving functional activities.in stroke patients. The study was carried out to determine the effects of thoracic Joint Mobilization on Pulmonary Functions of patients with stroke.
Detailed Description
INTRODUCTION Stroke is defined as sudden neurological deficit due to an abnormality in cerebral blood flow, with sign and symptoms lasting for more than 24 hours. Strokes can be grouped into two fundamental classification according to the American Stroke Association (ASA), first is ischemic (87%) and the second is Hemorrhagic (13%). In epidemiological and genetic studies a stroke subtype classification is useful indicator in our clinical practice. Many serious physical and cognitive deficits results due to injury to the brain tissue. Depending upon the region of the brain that is involved and amount of damage, a person can recovers from stroke. Stroke is associated with many primary and secondary complications. Here mentioned some primary complications. Sensation, Pain, Visual changes, Motor Function, Weakness, Alternation in Tone, Abnormal Reflexes, Altered Coordination, Altered Postural control and Balance. The main Indirect or secondary complications are Musculoskeletal Complications, Neurological Complications, Cardiovascular Complications, Pulmonary Complications, and Integumentary Complications. Pulmonary Functions are usually impaired in individuals with stroke. The common findings associated with pulmonary functions in Stroke patients are Decreased lung volumes, decreased pulmonary perfusion and vital capacity and altered chest wall excursion. Individuals with stroke are, associated with dysphagia which leads to dehydration and compromised nutrition. Dysphagia has been related with enlarged risk of pulmonary difficulties and also death. According to research evidence primary findings of dysphagia in patients having acute stroke significantly decreases complications. It also decreases the length of hospital stay and overall health expenditure. Dysphagia further leads to Aspiration. Aspiration, is penetration of food, liquid, saliva or gastric reflux into the airways. It usually occurs in acute phase of recovery or during swallowing. Aspiration is an important complication and can leads to aspiration pneumonia if left untreated, death can occur. Impaired Pulmonary functions limits physical activities as well. Because the decreased respiratory output is accompanied by increased oxygen demands required during altered movement patterns in stroke. Furthermore people with stroke usually undergo irregular breathing because of damage to the respiratory muscles (such as Diaphragm). Due to paralyzed respiratory muscles lungs and thorax cannot be sufficiently dilated. If this condition persists the thoracic tissues may become shortened and thoracic muscles undergo fibrosis to reduce the compliance of thorax. This leads to various complications like atelectasis, changes in muscles forces, which directly or indirectly obstruct the performance of daily living activities, and asymmetrical postures or movement foam, which may hamper the stability of motion there by. In stroke patients the respiratory functions are affected both directly and indirectly by the cardiopulmonary performance because they experience a deterioration in cardiovascular functioning and pulse rate. This disturbs the oxygen delivery and decline in the activity of the chest wall on the paralyzed side and its electrical activities. The changes in breathing mechanism and respiratory efficiency reflects about the extent of loss in the activity of chest wall, loss of symmetry and the extent of muscular paralysis of stroke patients. To correct above mentioned difficulties it is significant to have expansion of chest wall, to improve lung ventilation and to have suitable volume and capacities of lungs. As mentioned above stroke is accompanied by many secondary complications due to nervous system and musculoskeletal system insufficiencies related through brain impairments. Amongst many problems pulmonary disorders are further, strictly associated to life, difficulties with respiration and swallowing as well as language. Direct restrictive impairments accompanied due to non-utilization of paralyzed muscles and their trouble with movement elicits a secondarily decrease in cardiopulmonary functioning. Due to this, non-symmetric trunk encourages insufficient energy use related to gait, causing reduction in exercise endurance. Patients having hemiplegia due to stroke experiences deviated movement in posture, abnormal movement of trunk and motor control. Now a day's people preserve static posture for long periods due to which occurrence of cervical lordosis along with thoracic and lumbar kyphosis is growing day by day. Due to an inclination in thoracic kyphosis, restriction in expansion of chest and respiratory weakness of muscles occurs, thus decreasing lungs capacity and size of the thoracic cavity and distorting vertebral column arrangement. Our study focuses on the effects of thoracic joints mobilization and its effects on enhancing the pulmonary functions in stroke patients. Generally Rehabilitation programs target towards functional recovery of body. They neglect enhancement of cardiopulmonary system functioning. If investigator incorporate interventions related to respiration along with functional recovery, it possibly be additionally effective in stroke patients for enhancing functional doings such as gait. Many studies shows the effects of mobilization and its effects on pulmonary function. A study on The Immediate Effect of Chest Mobilization Technique on Chest Expansion in Patients of COPD with Restrictive Impairment. This study concluded that mobilization of rib cage joints improve ribcage mobility and reduced obstructive lung disease. Chest wall mobilization also improves the mobility of chest wall, reduces respiratory rate, increases tidal volume, improves ventilation, reduces dyspnea, decreases work of breathing and facilitate relaxation. Another study focuses on, the effect of thoracic region self-mobilization on chest expansion and pulmonary function. The purpose of this study was to find out the effects of thoracic region self-mobilization on chest expansion and pulmonary function in healthy adults. The outcome measures included in this study were to measure chest expansion during breathing, pulmonary functions, and expected pulmonary functions. There was no noteworthy change in pulmonary functions among intervention and control group. There was a noteworthy change in chest expansion between intervention and control group. Hence concluded that thoracic region self-mobilization is helpful for improving chest expansion in healthy adults. Our study focuses on the effects of thoracic joints mobilization and its effects on pulmonary functions in stroke patients. Generally Rehabilitation programs target towards functional recovery of body. They neglect enhancement of cardiopulmonary system functioning. If investigator incorporate interventions related to respiration along with functional recovery, it possibly be additionally effective in stroke patients for enhancing functional doings such as gait.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Pulmonary Functions, Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PULMONARY FUNCTION TEST (PFT) GROUP
Arm Type
Experimental
Arm Description
Thoracic joint Mobilization was applied on Experimental group. Thoracic Flexion: Patient sits on the treatment table with arms across the chest and hands on opposite shoulders. Stand facing the patient's left side. Thoracic Extension: Performed by asking sits on a treatment chair with arms folded across the chest and hands on opposite shoulders. Thoracic Segment Rotation: Performed by asking the patient to lie on left side. Place a pillow under patient's waist to assist left side bending. Position the patient's arms are folded across the chest with hands on opposite shoulders to stabilize the shoulder girdle and minimize movement there.
Arm Title
Control Group
Arm Type
Other
Arm Description
received conventional Chest physiotherapy Techniques for 30 minutes (including deep breathing, diaphragmatic breathing exercises, Self-stretching exercises for accessory respiratory muscles, Respiratory Resistance training by incentive spirometer) followed by 10 min rest.
Intervention Type
Other
Intervention Name(s)
Pulmonary Function Test group
Intervention Description
The interventional group received the same conventional Chest physiotherapy Techniques for 30 minutes followed by 10 minutes rest. The patients then received additional 15 minutes protocol of thoracic joint mobilization
Intervention Type
Other
Intervention Name(s)
Control Group
Intervention Description
received conventional Chest physiotherapy Techniques for 30 minutes (including deep breathing, diaphragmatic breathing exercises, Self-stretching exercises for accessory respiratory muscles, Respiratory Resistance training by incentive spirometer) followed by 10 min rest.
Primary Outcome Measure Information:
Title
Forced expiratory Volume in one sec (FEV1)
Description
Pulmonary Functions: Forced expiratory Volume in one sec (FEV1) was measured in litre/sec through digital spirometer
Time Frame
6 months
Title
Forced vital capacity (FVC)
Description
Pulmonary Functions: Forced vital capacity (FVC) was measured in litre through digital spirometer
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: A sample of 26 patients with stroke without any history of recent pulmonary involvement Diagnosed with stroke by computed tomography (CT) or magnetic resonance imaging (MRI), with disease duration of at least six months after the onset of stoke. Score 24 points or higher on MMSE to ensure that they able to understand and follows the researcher's order. Exclusion Criteria: The subjects having any recent surgery, unstable blood pressure and having acute infections were excluded from the study.
Facility Information:
Facility Name
Shehla Gul
City
Attock
State/Province
Punjab
ZIP/Postal Code
43600
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
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The Effects of Thoracic Joint Mobilization on Pulmonary Functions of Patients With Stroke

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