NCT06658236

Brief Summary

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.

Trial Health

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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

September 26, 2024

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

October 24, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 26, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2024

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

November 5, 2024

Status Verified

November 1, 2024

Enrollment Period

3 months

First QC Date

October 24, 2024

Last Update Submit

November 3, 2024

Conditions

Keywords

chest cirtometryCerebral palsythoracic mobilityPNF of upper extremitychest expansionBPAT

Outcome Measures

Primary Outcomes (1)

  • The Brompton BPAT (Breathing Pattern Assessment Tool)

    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 Outcomes (2)

  • Measuring tape for measuring chest expansion

    The test for measuring chest mobility using a non-stretch measuring tape typically takes about 5 to 10 minutes.

  • Pediatric Sleep Questionnaire

    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

Study Arms (2)

Proprioceptive Neuromuscular Facilitation Group

EXPERIMENTAL

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

Chest Expansion Exercise Group

EXPERIMENTAL

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

Interventions

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.

Proprioceptive Neuromuscular Facilitation Group

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

Chest Expansion Exercise Group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International University

Lahore, Punjab Province, 54700, Pakistan

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Naima Khalid, MS*

    Riphah International Univerisity

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Muhammad Asif Javed, MS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will get separate treatment protocols, and possible efforts will be put to mask both groups about the treatment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: It will be a randomized control trial in which non-probability convenient sampling will be used. Two groups will be formed in which participants will be randomly divided. Group A will receive upper Extremity proprioceptive neuromuscular facilitation. Group B will receive chest expansion exercises.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2024

First Posted

October 26, 2024

Study Start

September 26, 2024

Primary Completion

December 15, 2024

Study Completion

January 1, 2025

Last Updated

November 5, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations