| CTRI Number |
CTRI/2024/07/070119 [Registered on: 05/07/2024] Trial Registered Prospectively |
| Last Modified On: |
05/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Hand function and Postural control relations in children with cerebral palsy |
|
Scientific Title of Study
|
Relationship between Postural Control, Quality of Upper Limb Skills and Functional Independence in children with cerebral palsy: a cross sectional-study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shruti K |
| Designation |
postgraduate student |
| Affiliation |
Kasturba medical college, mangalore |
| Address |
Department of Physiotherapy, Kasturba Medical College, Mangalore, Centre for Basic Sciences, Bejai, Mangalore
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
9743108007 |
| Fax |
|
| Email |
shruti.konar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shruti K |
| Designation |
postgraduate student |
| Affiliation |
Kasturba medical college, mangalore |
| Address |
Department of Physiotherapy, Kasturba Medical College, Mangalore, Centre for Basic Sciences, Bejai, Mangalore
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
9743108007 |
| Fax |
|
| Email |
shruti.konar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shruti K |
| Designation |
postgraduate student |
| Affiliation |
Kasturba medical college, mangalore |
| Address |
Department of Physiotherapy, Kasturba Medical College, Mangalore, Centre for Basic Sciences, Bejai, Mangalore
KARNATAKA
575004
India |
| Phone |
9743108007 |
| Fax |
|
| Email |
shruti.konar@gmail.com |
|
|
Source of Monetary or Material Support
|
| infrastructural support - Kasturba Medical College, Centre for basic sciences, Bejai, Mangalore, Karnataka, India- 575004 |
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College |
| Address |
Kasturba Medical College, Centre for basic sciences, Bejai, Mangalore, Karnataka, India- 575004 |
| 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 |
| Dr Amitesh Narayan |
Neuro sensory developmental unit, KMC |
Department of Physiotherapy, Kasturba Medical College, Mangalore, Centre for Basic Sciences, Bejai
Dakshina Kannada
KARNATAKA |
9448039380
Amitesh.narayan@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, KMC, Mangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P039||Newborn affected by complication of labor and delivery, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
1. Medical diagnosis of spastic cerebral palsy
2. Both genders with an age range of 3 to 8 years
3. Gross motor function classification system level 1 to 5
4. Ability to understand and follow instructions |
|
| ExclusionCriteria |
| Details |
1. Children who have visual and hearing problems
2. History of botulinum toxin injection or surgery in the last 6 months |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Postural Control with Early clinical evaluation of balance Scale
2. Quality of upper limb skills with Quality of upper extremity Skills test scale
|
Baseline only |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Functional independence with Pediatric evaluation of disability inventory computer adaptive test |
baseline |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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)
|
19/07/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This study aims to fill a crucial knowledge gap by exploring the interplay between postural control, upper limb skills, and functional independence in children with cerebral palsy (CP). The hypothesis suggests that better postural control is associated with higher quality of upper limb skills in children with spastic cerebral palsy. By utilizing standardized assessment tools for postural control, upper limb skills, and functional independence, this research endeavors to provide valuable insights into potential strategies for optimizing daily activities and promoting greater autonomy and quality of life for children living with CP. |