Upper Extremity Proprioceptive Neuromuscular Facilitation and Chest Expansion Exercises in Cerebral Palsy

November 3, 2024 updated by: Riphah International University

Comparative Effects of Upper Extremity Proprioceptive Neuromuscular Facilitation and Chest Expansion Exercises on Thoracic Mobility in Children With Cerebral Palsy

Thoracic mobility is the mobility of the thoracic spine, and the rib cage is often measured by the degree of thorax expansion during breathing. Thoracic mobility is affected by many reasons, such as breathing mechanics, muscle stiffness, a sedentary lifestyle, and poor posture. The risk of respiratory illness should be assessed in all individuals with Cerebral palsy. Poor mobility of the thoracic will lead to limited breathing capacity and difficulty in daily life activities. Increasing thoracic mobility enhances dynamic alignment and functional movement. Proprioceptive Neuromuscular Facilitation (PNF) of upper extremity and chest expansion exercise can improve thoracic mobility. In this method, a physiotherapeutic approach is used in muscle strengthening, lengthening, and endurance training. The study aims to analyze the effect of an upper limb training program based on PNF techniques and chest expansion exercises on the thoracic mobility of a cerebral palsy patient.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The current study will be a randomized control trial; data will be collected from the Lahore Garrison Institute of Special Education. The study will include 14 patients who are equally divided into two groups and randomly allocated. Inclusion criteria for the study will be either gender of CP patients at Gross Motor Function Classification System level I to III, who had no orthopedic surgery in the last 6 months and have a diagnosis of CP by doctors. Patients with scoliosis and any acute or current respiratory infection or other respiratory conditions, such as asthma or influenza, will be excluded from the study. One experimental group will perform upper extremity PNF combined with elastic resistance bands; the other group will perform chest expansion exercises, which are upper extremity flexion, abduction, and external rotation exercises with an elastic band. The outcomes to be analyzed will be thoracic mobility. Data collection will be done before and after the intervention. Tools used for data collection will be Brompton BPAT breathing pattern assessment tool (BPAT) and chest cirtometry. Data will be analyzed through SPSS version 23.00.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 54700
        • Recruiting
        • Riphah International University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Naima Ahmad Khalid, MS*
        • Sub-Investigator:
          • Fareeha Kausar, MS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Gross Motor Function Classification System level of I to III.
  • BPAT score ≥ 4.
  • Either gender will be included

Exclusion Criteria:

  • Recent chest infection.
  • Children who are hospitalized
  • Scoliosis
  • No orthopedic surgery in last 6 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Proprioceptive Neuromuscular Facilitation Group
Group A will perform PNF exercises using a yellow Thera-Band with a flexion-abduction-external rotation pattern, followed by extension-adduction-internal rotation, all with the elbow extended. The protocol includes three sets of 10 reps, with 60-second rest intervals conducted thrice a week for 12 weeks.
Other: Proprioceptive Neuromuscular Facilitation
Group A will follow a PNF-based training protocol to enhance strength, flexibility, and coordination. The exercises include two main movement patterns: flexion-abduction-external rotation with the elbow extended and extension-adduction-internal rotation with the elbow extended. These patterns target the muscles around the shoulder and upper chest. A yellow Thera-Band adds light resistance, increasing muscle engagement. The protocol also employs the reversal of antagonists technique, alternating between opposing muscle groups for balanced development and improved coordination. Participants will complete three sets of ten repetitions per session, with a 60-second rest between sets. The program spans 12 weeks, with three weekly sessions, allowing for consistent progress and muscle recovery. This structured approach aims to improve functional mobility and the performance of activities involving similar movements, offering a comprehensive training strategy through PNF and resistance.
Experimental: Chest Expansion Exercise Group
Group B was instructed to 1) breathe normally at rest; 2) perform upper extremity flexion, abduction, and external rotation with inhalation, followed by extension, adduction, and internal rotation with exhalation using a yellow Thera-Band. Subjects completed three sets of 10 repetitions with a 1-minute rest between sets thrice a week for 12 weeks.
Other: Chest Expansion Exercises
Group B participants followed a breathing-coordinated exercise protocol using a yellow Thera-Band to improve upper extremity function. The protocol began with subjects breathing generally at rest. They were then instructed to synchronize their movements with their breathing: performing upper extremity flexion, abduction, and external rotation during inhalation, followed by extension, adduction, and internal rotation during exhalation. This coordination between breathing and movement aimed to enhance muscle activation and control. Each session included three trials of ten repetitions for each exercise, with a 1-minute rest between trials. The protocol was conducted three times per week over 12 weeks. This approach was designed to promote strength, flexibility, and coordination in the upper body while integrating breath control, which may also support relaxation and better movement efficiency. The structured schedule ensures consistent practice and gradual improvement over the 12 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The Brompton BPAT (Breathing Pattern Assessment Tool)
Time Frame: The BPAT is completed with the patient seated comfortably in a supported chair for at least 5 minutes, with data collection taking approximately 1 minute.
The BPAT (Breathing Pattern Assessment Tool) is a structured method for recording data collected during a respiratory physiotherapy assessment. It evaluates several components: (i) chest and abdominal wall movement, (ii) the sound of inspiratory flow, (iii) the sound of expiratory flow, (iv) the pathway of inspiration and expiration, (v) signs of air hunger (such as yawning, sighing, and deeper breaths), (vi) respiratory rate (RR), and (vii) breathing rhythm. Each component is scored from 0 to 2, where 0 represents normal function, and 2 indicates severe Dysfunctional Breathing, resulting in a total score ranging from 0 to 14. The BPAT is completed with the patient seated comfortably in a supported chair for at least 5 minutes, with data collection taking approximately 1 minute. A BPAT score of 4 or higher has been validated as a threshold for diagnosing Breathing Pattern Disorder, with ROC analysis showing an AUC of 0.938 (0.885-0.991), 95% sensitivity, and 78% specificity.
The BPAT is completed with the patient seated comfortably in a supported chair for at least 5 minutes, with data collection taking approximately 1 minute.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Measuring tape for measuring chest expansion
Time Frame: The test for measuring chest mobility using a non-stretch measuring tape typically takes about 5 to 10 minutes.
Chest mobility will be assessed using a non-stretch measuring tape placed at the level of the xiphoid process, measuring both at rest and during maximal inhalation and exhalation. Interclass correlation coefficients for chest expansion measurements using the tape have been reported to range from 0.95 to 0.97, indicating high reliability.
The test for measuring chest mobility using a non-stretch measuring tape typically takes about 5 to 10 minutes.
Pediatric Sleep Questionnaire
Time Frame: The test for assessing pediatric Obstructive Sleep Apnea using the symptom scale typically takes about 10 to 15 minutes to complete. This duration includes the time required for the caregiver or parent to respond to the 22 symptom items and any necessary
The scale consists of 22 symptom items that assess various aspects of pediatric Obstructive Sleep Apnea (OSA), including the frequency of snoring, loud snoring, observed apneas, difficulty breathing during sleep, daytime sleepiness, and behaviours such as inattention or hyperactivity. It has demonstrated a sensitivity of 0.85 and a specificity of 0.87, indicating its effectiveness in identifying children at risk for OSA.
The test for assessing pediatric Obstructive Sleep Apnea using the symptom scale typically takes about 10 to 15 minutes to complete. This duration includes the time required for the caregiver or parent to respond to the 22 symptom items and any necessary

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Riphah International University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Naima Khalid, MS*, Riphah International Univerisity

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 26, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 15, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 24, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 26, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 5, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REC/RCR/AHS/24/Naima Khalid

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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