| CTRI Number |
CTRI/2024/08/071909 [Registered on: 05/08/2024] Trial Registered Prospectively |
| Last Modified On: |
01/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluation of Balance in Children with Neuro-motor Illness with and without visual difficulties:
A comparative study |
|
Scientific Title of Study
|
Evaluation of Postural Control in Children with Neuro-motor Disorders with and without visual impairment:
A comparative 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 |
Laxmi Simanlal |
| Designation |
Post graduate |
| Affiliation |
MGM School of Physiotherapy |
| Address |
Room no- 55, 2nd floor Department of Physiotherapy, Mahatma Gandhi Mission Hospital, Sector- 1 Kamothe Navi Mumbai
Raigarh
MAHARASHTRA
410209
India |
| Phone |
8449039289 |
| Fax |
|
| Email |
laxmiarya@mgmsopnm.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amrita Ghosh |
| Designation |
Head of Neuro-physiotherapy Department |
| Affiliation |
MGM School of Physiotherapy |
| Address |
MGM Institute of Health Sciences MGM School of Physiotherapy, Department of Neuro-Physiotherapy, Sector-1 Kamothe, Navi Mumbai
Raigarh
MAHARASHTRA
410209
India |
| Phone |
02227437866 |
| Fax |
|
| Email |
aghosh@mgmsopnm.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amrita Ghosh |
| Designation |
Head of Neuro-physiotherapy Department |
| Affiliation |
MGM School of Physiotherapy |
| Address |
MGM Institute of Health Sciences MGM School of Physiotherapy, Department of Neuro-Physiotherapy Sector-1 Kamothe, Navi Mumbai
Raigarh
MAHARASHTRA
410209
India |
| Phone |
02227437866 |
| Fax |
|
| Email |
aghosh@mgmsopnm.edu.in |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Mission Hospital, Sector -1, Kamothe Navi Mumbai- 410209,Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
MGM School of Physiotherapy |
| Address |
MGM Hospital, Department of Physiotherapy, Sec-1, Kamothe Navi Mumbai Maharashtra 410209 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Laxmi Simanlal Arya |
MGM MEDICAL COLLEGE AND HOSPITAL |
MGM School of Physiotherapy, Department of Neuro-Physiotherapy Sector-1 Kamothe, Navi Mumbai
-410209 MGM School of Physiotherapy, Sector-1 Kamothe, Navi
Mumbai -410209
Raigarh
MAHARASHTRA
Raigarh
MAHARASHTRA |
8449039289
laxmiarya@mgmsopnm.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MGM DENTAL COLLEGE AND HOSPITAL - INSTITIUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G838||Other specified paralytic syndromes, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
1. Age group 7-14 years, including both boys and girls
2. Children diagnosed with Neuro-motor disorders.
3. Children with Gross Motor Function Classification System (GMFCS) score between Level 1 - Level 3 ( ie. Walking independently to walking with hand held mobility device)
4. Children with impaired vision and disability certificate. (not a normal eyesight and not more than 70%)
|
|
| ExclusionCriteria |
| Details |
1.Typically developing children
2.Any muscular impairment involving Spine, Lower extremity and Upper extremity, congenital malformation of physical order.
3.Children with hearing impairments
4.Children with severe cognitive deficit (no understanding of the simple orders of the test)
• Children with visual acuity to 3/60 (0.05) - blindness.
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Centre of Pressure (CoP) trajectory in Force plate |
20-30 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pediatric Balance Scale |
15-20 minutes |
| Time Up and Go test |
5 minutes |
| Functional reach test |
5 minutes |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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)
|
13/08/2024 |
| 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="8"
Days="14" |
|
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
|
1. The
procedure and purpose of the study will be explained to all the parents. 2. Consent will be
obtained from both the child and the parent for the study. 3. After screening for
the inclusion and exclusion criteria, the first child who is diagnosed with any
Neuro-motor Disorders without any visual impairment will be recruited. This
child will form Group A. 4. The next child will be
recruited who is diagnosed with the same type of Neuromotor Disorder along with
vision impairment. The child should also match the age, gender, and Body Mass
Index of the previous child. This child will form Group B. 5. This procedure will
continue till there are 26 children in Group A and Group B each. 6. Postural Control will
be assessed for all the children in both groups Postural Control in the Centre
of Pressure (CoP) trajectory in sway will be assessed for all the children in
both groups. For children with visual impairments, alternate visual and
verbal tasks will be given and provided with lots of breaks. For braille
learners, the expected progression of numeracy, reading, and writing, is not
the same as the progression of the same skills in sighted peers. If needed,
enlarge reading materials ahead of time off. The copies have high contrast,
with photocopies, making sure to present only one page at a time, so that there
is no interference from text showing through from the page underne Postural
Control assessment will include 1. Centre
of Pressure (CoP) trajectory in Sway which will be analysed by using
Matlab software for postural transition for dynamic stability. 2. Paediatric
Balance test for overall balance. 3. Functional
reach test 4. Timed
up and go test for anticipatory and reactive postural control The Postural Control assessment data will be analysed by
SPSS. 1. A paired T-test will be
used to assess the Age and body weight of the participants within the group. 2. Unpaired T-Test will be
used to assess the age, and body weight of the participants between two groups. 3. For scales and outcome
measures, the Wilcoxon sign test will be used for evaluating within the Same group of participants. 4. Mann Whitney - U- test will be used for evaluating the
scales and outcome measures for the participants between groups.
|