| CTRI Number |
CTRI/2024/03/064797 [Registered on: 27/03/2024] Trial Registered Prospectively |
| Last Modified On: |
22/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
analytical cross sectional study |
| Study Design |
Other |
|
Public Title of Study
|
Strength of respiratory muscle diaphragm and its effect on arm function and sitting balance in children with cerebral palsy
|
|
Scientific Title of Study
|
Diaphragm strength and its association with trunk control and upper limb function in children with 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 |
Mrunmayee Katte |
| Designation |
Postgraduate Student |
| Affiliation |
Kasturba Medical College, Mangalore |
| Address |
Department of Physiotherapy, Kasturba Medical College,
Mangalore, Center for Basic Sciences, Bejai, Mangalore
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
8308694889 |
| Fax |
|
| Email |
mrunmayee.mchpmlr2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Amitesh Narayan |
| Designation |
Professor |
| Affiliation |
Kasturba Medical College, Mangalore |
| Address |
Department of Physiotherapy, Kasturba Medical College,
Mangalore, Center for Basic Sciences, Bejai, Mangalore
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
9448039380 |
| Fax |
|
| Email |
amitesh.narayan@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Mrunmayee Katte |
| Designation |
Postgraduate Student |
| Affiliation |
Kasturba Medical College, Mangalore |
| Address |
Department of Physiotherapy, Kasturba Medical College,
Mangalore, Center for Basic Sciences, Bejai, Mangalore
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
8308694889 |
| Fax |
|
| Email |
mrunmayee.mchpmlr2023@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College, Mangalore, Center for Basic Sciences, Bejai, Mangalore -575004. |
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College |
| Address |
Department of Physiotherapy, Kasturba Medical College,
Mangalore, Center for Basic Sciences, Bejai, Mangalore. |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Mrunmayee Katte |
Kasturba Medical College, Mangalore |
Neurosensory Developmental Unit, Kasturba Medical College,Center for Basic Sciences, Bejai, Mangalore -575004
Dakshina Kannada
KARNATAKA |
8308694889
mrunmayee.mchpmlr2023@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, KMC, Mangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G800||Spastic quadriplegic cerebral palsy, (2) ICD-10 Condition: G801||Spastic diplegic cerebral palsy, (3) ICD-10 Condition: G802||Spastic hemiplegic cerebral palsy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
1. Children diagnosed with spastic cerebral palsy.
2. Gross Motor Function Classification System levels- I – V
3. Able to understand the commands and follow them. |
|
| ExclusionCriteria |
| Details |
1. acute or chronic pulmonary conditions
2. acute musculoskeletal conditions
3. any upper limb surgery in past 6 months |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| diaphragm strength and its association level of trunk control |
baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="33"
Sample Size from India="33"
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)
|
25/04/2024 |
| 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="1"
Months="2"
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
|
Aim- To find the association between the strength of diaphragm with trunk control and upper limb function in children with cerebral palsy. Methodology - Children with spastic cerebral palsy between the age group 7-15 will be recruited for the study. Once the informed consent is taken from the guardian/ parents of the child, the diaphragm strength of the children will be assessed using the Micro- Respiratory Pressure meter device. using this handheld non-invasive device Maximum Inspiratory Pressure (MIP) will be calculated, which represents the diaphragm strength. The diaphragm strength will be compared in the age-matched children with typical development. The trunk control will be assessed using the Segmental Assessment of Trunk Control (SATCo) scale and the arm function will be assessed using the Quality of Upper Extremity Skill Test (QUEST) scale. After the three components are obtained, statistical analysis will be done to find out the relationship between diaphragm strength, trunk control, and upper limb function in children with cerebral palsy. Need of the study - Literature has proven that the diaphragm plays an important role in maintaining lumbar and rib stability which is necessary for upper limb movements. However, no direct association between the two components has been found. Due to a lack of literature on the role of the diaphragm muscle in trunk control, further studies are needed to be done. |