Cerebral PalsyNCT06658236
Upper Extremity Proprioceptive Neuromuscular Facilitation and Chest Expansion Exercises in Cerebral Palsy
A study testing Proprioceptive Neuromuscular Facilitation and Chest Expansion Exercises in people with Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Proprioceptive Neuromuscular Facilitation and Chest Expansion Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 sitePakistan
- Study dates
- 26 Sep 2024to 1 Jan 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Gross Motor Function Classification System level of I to III.
- BPAT score ≥ 4.
- Either gender will be included
Who cannot join
- Recent chest infection.
- Children who are hospitalized
- Scoliosis
- No orthopedic surgery in last 6 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Riphah International University
Lahore, Punjab Province, 54700
Imran Amjad, PhD, +9233224390125, Imran.amjad@riphah.edu.pk
Muhammad Asif Javed, MS, +923224209422, a.javed@riphah.edu.pk
About this study
Official title: 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.
Read the 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.
- Conditions
- Cerebral Palsy
- Being tested
- Proprioceptive Neuromuscular Facilitation, Chest Expansion Exercises
- Keywords
- chest cirtometry, Cerebral palsy, thoracic mobility, PNF of upper extremity, chest expansion, BPAT
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proprioceptive Neuromuscular FacilitationOther
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.
Chest Expansion ExercisesOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Chest Expansion Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: The test for measuring chest mobility using a non-stretch measuring tape typically takes about 5 to 10 minutes.
Pediatric Sleep Questionnaire
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2024
- Study start26 Sep 2024
- Primary completion15 Dec 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Naima Khalid, MS*, Principal investigator, Riphah International Univerisity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06658236
- Sponsor's protocol ID
- REC/RCR/AHS/24/Naima Khalid
- Status last verified
- Nov 2024
- First submitted
- 24 Oct 2024
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Upper Extremity Proprioceptive Neuromuscular Facilitation and Chest Expansion Exercises on Thoracic Mobility in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06658236
- Acronym / sponsor ID
- REC/RCR/AHS/24/Naima Khalid
- Conditions
- Cerebral Palsy
- Keywords
- chest cirtometry, Cerebral palsy, thoracic mobility, PNF of upper extremity, chest expansion, BPAT
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 26 Sep 2024 (actual)
- Primary completion
- 15 Dec 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 26 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Proprioceptive Neuromuscular Facilitation Group | Experimental | Other: Proprioceptive Neuromuscular FacilitationGroup 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. |
| Chest Expansion Exercise Group | Experimental | Other: Chest Expansion ExercisesGroup 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Gross Motor Function Classification System level of I to III.
- BPAT score ≥ 4.
- Either gender will be included
Key exclusion criteria (4 listed)
- Recent chest infection.
- Children who are hospitalized
- Scoliosis
- No orthopedic surgery in last 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proprioceptive Neuromuscular FacilitationGroup 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. | Other | Proprioceptive Neuromuscular Facilitation Group |
| Chest Expansion ExercisesGroup 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 | Other | Chest Expansion Exercise Group |
Primary outcome
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.
2 secondary outcomes
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.
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Naima Khalid, MS* principal investigator
Riphah International Univerisity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proprioceptive Neuromuscular Facilitation and Chest Expansion Exercises in people with Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Imran Amjad, PhD (+9233224390125, Imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2024.