| CTRI Number |
CTRI/2024/05/068171 [Registered on: 31/05/2024] Trial Registered Prospectively |
| Last Modified On: |
29/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Identification Of Relation Between the Oxygen Usage During Exercise and Hospital Admission Due To Breathing Problem in Cerebral Palsy Children |
|
Scientific Title of Study
|
To Determine the Relation Between Respiratory Hospitalization and Aerobic Capacity in Adoloscents With GMFCS Level 1-3 Cerebral Palsy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shraddha Nayak |
| Designation |
PG student |
| Affiliation |
The Oxford College Of Physiotherapy |
| Address |
Department of Paediatric Physiotherapy,
No.6/9, 1st Cross, Begur Road, Hongasandra, Bangalore-560068 Karnataka, India
Bangalore
KARNATAKA
560068
India |
| Phone |
7975871320 |
| Fax |
|
| Email |
shraddhanayak2000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajalakshmi |
| Designation |
Asst. Professor |
| Affiliation |
The Oxford College Of physiotherapy |
| Address |
Department of Paediatric Physiotherapy,
No.6/9, 1st Cross, Begur Road, Hongasandra, Bangalore-560068 Karnataka, India
Bangalore
KARNATAKA
560068
India |
| Phone |
9986091220 |
| Fax |
|
| Email |
srajivasanth@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
R Vasanthan |
| Designation |
Principal |
| Affiliation |
The Oxford College Of physiotherapy |
| Address |
Department of Paediatric Physiotherapy,
No.6/9, 1st Cross, Begur Road, Hongasandra, Bangalore-560068 Karnataka, India
Bangalore
KARNATAKA
560068
India |
| Phone |
9916919685 |
| Fax |
|
| Email |
physiotherapyprincipal@theoxford.edu |
|
|
Source of Monetary or Material Support
|
| Samarthanam Trust for the Disabled,CA:39, 15th Cross, 16th Main, Sector-4, HSR Layout, Bangalore - 560102 |
| Sri Sai public school, 4th Main, ITTINA Apartment, Road, Begur Rd, behind Kavya Nursing home, Hongasandra, Bengaluru, Karnataka 560068 |
| The Aasare Special School, Mico Layout, Hongasandra, Bengaluru, Karnataka 560068 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Shraddha Nayak |
The Oxford College of Physiotherapy |
Department of Paediatric Physiotherapy,
No.6/9, 1st Cross, Begur Road, Hongasandra, Bangalore-560068 Karnataka, India
Bangalore
KARNATAKA |
7975871320
shraddhanayak2000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Oxford College of Physiotherapy Review Board for Ethics and Research (TOCPTRBER) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Adoloscents from age 10 years to 19years |
| Patients |
(1) ICD-10 Condition: G801||Spastic diplegic cerebral palsy, (2) ICD-10 Condition: G802||Spastic hemiplegic cerebral palsy, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
19.00 Year(s) |
| Gender |
Both |
| Details |
CEREBRAL PALSY GROUP:
1. Adolescents who are ambulatory and diagnosed with spastic cerebral palsy
2. Age group 10 to 19years
3. GMFCS level I and II
4. GMFCS level III - ambulating and capable of meeting the test criterions.
5. Cognitively, capable of following simple commands
6. Adolescents whose parents / guardians are available with medical records for hospitalization history
NORMAL POPULATION:
1. Age matched adolescents - 10 to 19years. |
|
| ExclusionCriteria |
| Details |
CEREBRAL PALSY GROUP:
1. GMFCS – level 4 and level 5
2. A severe intellectual disability – Not capable of comprehending with the test instructions.
FOR BOTH GROUP:
1. Having undergone surgery in the previous six months.
2. Recent injury
3. Systemic illness that prevents them from performing aerobic testing
4. Respiratory disease or hospitalization –
5. Non-recurrent respiratory episodes (e.g., laryngospasm.
5. Unrelated specific respiratory conditions
(e.g., tracheomalacia). |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| semi standard questionnaire including Number of respiratory related hospitalizations |
one time study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Aerobic capacity ( VO2 max calculation ) |
one time study |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/06/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Background : Cerebral palsy (CP) is a heterogeneous group of permanent movement disorders stemming from non-progressive lesions or abnormalities in the developing brain. Its prevalence is estimated at 2.95 per 1000 children, signifying its significant impact on pediatric health. Respiratory complications have emerged as critical factors contributing to morbidity and mortality among CP individuals, underscoring the urgent need for comprehensive understanding and proactive management of this aspect of the condition.
This study aims to bridge the gap in the literature by investigating the relationship between aerobic capacity and respiratory-related hospitalizations in adolescents with CP. Despite advancements in medical care, respiratory issues persist as formidable challenges for CP individuals. Integrating respiratory function assessments into routine evaluations is imperative to address these challenges effectively and enhance care outcomes. Methodology: By employing a methodology, including a semi standard questionnaire for information regarding respiratory associated hospitalization and aerobic capacity testing through shuttle walk/run test, this study endeavors to yield meaningful insights into the correlation between aerobic fitness and respiratory health outcomes in CP adolescents. Outcome: The outcome measures encompass GMFCS categorization, BMI assessment using Indian Academy of Pediatrics guidelines, the Physical Activity Readiness Questionnaire for Children - Plus (PARQ-P), and VO2 max calculations. These measures are meticulously chosen to provide comprehensive data for analysis and ensure the reliability and validity of the findings. Statistical Analysis: Statistical analysis will be conducted utilizing Spearman’s rank correlation and odds ratios.
In conclusion, this research holds significant promise in advancing our understanding of the complex relationship between aerobic capacity and respiratory health in adolescents with CP. By identifying key associations and risk factors, the study aims to empower healthcare professionals with actionable insights to mitigate respiratory complications, ultimately improving the quality of life and long-term outcomes for individuals living with CP. |