| CTRI Number |
CTRI/2018/10/015924 [Registered on: 08/10/2018] Trial Registered Prospectively |
| Last Modified On: |
05/05/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Rehabilitation Orthotics] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluation of low cost, customized orthoses for improvement of upper limb function in children with congenital hemiparesis |
|
Scientific Title of Study
|
ORGAN - LOW COST BIOMECHATRONIC REHABILITATIVE SOLUTIONS FOR CHILDREN WITH CONGENITAL HEMIPARESIS |
| Trial Acronym |
ORGAN |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jitendra Kumar Sahu |
| Designation |
Additional Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Room 5108, Block 5A, Advanced Pediatric Center, Post Graduate Institute of Medical Education and Research, Chandigarh, India
Chandigarh
CHANDIGARH
160012
India |
| Phone |
|
| Fax |
|
| Email |
jsh2003@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neelesh Kumar |
| Designation |
Principal Scientist, Biomedical Instrumentation Unit |
| Affiliation |
CSIR-Central Scientific Instruments Organisation |
| Address |
CSIR-Central Scientific Instruments Organisation,
Sector 30-C, Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
|
| Fax |
|
| Email |
neel5278@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jitendra Kumar Sahu |
| Designation |
Additional Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Room 5108, Block 5A, Advanced Pediatric Center, Post Graduate Institute of Medical Education and Research, Chandigarh, India
Chandigarh
CHANDIGARH
160012
India |
| Phone |
|
| Fax |
|
| Email |
jsh2003@gmail.com |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF SCIENCE AND TECHNOLOGY, TECHNOLOGY BHAVAN, NEW MEHRAULI ROAD, NEW DELHI-110016 |
|
|
Primary Sponsor
|
| Name |
DEPARTMENT OF SCIENCE AND TECHNOLOGY |
| Address |
New Delhi, India |
| Type of Sponsor |
Government funding agency |
|
|
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 Jitendra Kumar Sahu |
Post Graduate Institute of Medical Education and Research |
Room 5108,5A, Advanced Pediatric Centre, PGIMER, Sector 12, Chandigarh-160012
Chandigarh
CHANDIGARH |
7087009202
jsh2003@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Post Graduate Institute of Medical Education and Research, Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G00-G99||Diseases of the nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Biomechatronic rehabilitation |
Customized Orthoses/Exoskeleton for upper limb |
| Comparator Agent |
Not applicable as a single arm study. |
Not applicable as a single arm study. |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. Diagnosis of Hemiplegic cerebral palsy
2. Willing for follow-up during study period
3. Gross Motor Function Classification System Level 1 or 2
|
|
| ExclusionCriteria |
| Details |
1. Seizures uncontrolled
2. Parents declined consent
3. Child with hearing or visual impairment affecting participation
4. Planning for other intervention during intervention period eg. BOTOX/ Orthopedic procedure
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Functional skills of upper limb
a. Change in Goal attainment scaling/Other upper limb functional scale
b.Change in Modified Ashworth Scale of affected upper limb
c. Acceptability of provided Orthoses
d. Withdrawal/compliance issues
|
Baseline, 3 and 6 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Acceptability of provided Orthoses |
baseline day 1, day 2, 2 week, 4 week, 8 week, 12 week, 16 week, 20 week, 24 week |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
08/10/2018 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The proposed orthoses, which is an augmenting exoskeleton, to assist limb movements will be developed by Dr Neelesh Kumar and team in colloboration with PGIMER. Eligible children with hemiparetic cerebral palsy will be screened and enrolled for participation in the study. Informed consent from parents will be obtained. 10-15 children will be studied. This will be a feasibility study. Effectiveness outcome measurements as improvement in function of upper limb will be assessed. Acceptability of provided orthoses will also be assessed. |