| CTRI Number |
CTRI/2018/07/015011 [Registered on: 24/07/2018] Trial Registered Prospectively |
| Last Modified On: |
29/12/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Upper limb Pilates exercise on handwriting in school children :an experimental study |
|
Scientific Title of Study
|
Upper limb Pilates on handwriting in school children :an experimental study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
shruti yadav |
| Designation |
post graduate student in departmenrt of pediatric physiotherapy |
| Affiliation |
KAHER institute of physiotherapy (department off pediatric physiotherapy |
| Address |
Plot no.384 2nd main 6th cross west kumarswamy layout belagavi
KAHER Institute of physiotherapy nehru nagar belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
8277609599 |
| Fax |
|
| Email |
shrutiyadavatschool@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Snehal Dharmayat |
| Designation |
Associate Professor |
| Affiliation |
KAHER institute of physiotherapy |
| Address |
KAHER Institute of physiotherapy nehru nagar belagavi
KAHER Institute of physiotherapy nehru nagar belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9448305413 |
| Fax |
|
| Email |
snehdharma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
shruti yadav |
| Designation |
post graduate student in departmenrt of pediatric physiotherapy |
| Affiliation |
KAHER institute of physiotherapy |
| Address |
KAHER Institute of physiotherapy nehru nagar belagavi
KAHER Institute of physiotherapy nehru nagar belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
8277609599 |
| Fax |
|
| Email |
shrutiyadavatschool@gmail.com |
|
|
Source of Monetary or Material Support
|
| KAHER institute of physiotherapy
nehru nagar belagavi karnataka 590010 |
|
|
Primary Sponsor
|
| Name |
KAHER Institute of physiotherapy |
| Address |
KAHER Institute of physiotherapy nehru nagar belagavi 590010 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| shruti yadav |
mahila vidyalaya english medium school ,contonment board english medium school |
camp
Belgaum
KARNATAKA |
8277609599
shrutiyadavatschool@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
children with poor handwriting |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
none |
none |
| Intervention |
structured exercise program |
1)Shoulder blade press ups
2)Shoulder rotations
3) Scapula Elevation
4) Scapula Depression
5) Scapula Protraction
6) Scapula Retraction
7)Front Biceps Curl
8)Push up
9) Pelvic curl
10) Chest lift
11)Chest lift with rotation
12)Criss cross
13)Roll up
14) Spine stretch
15 ) Spine twist
16)Roll over
17) Cat stretch
18)Up stretch
Intially exercise will be of 3 sets with 3 repeatation and progression will be done upto 6 repeatation |
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
children scoring <75% for total word legibility and <76%in total letter legibility |
|
| ExclusionCriteria |
| Details |
1)Recent fracture of upper limb
2) Recent systemic illness
3)Respiratory illness
4) Known disabilities of upper limb affecting fine motor activities
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| evaluation tool for childrens handwriting |
before starting the exercise program and after 8th week of exercise |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| evaluation tool for childrens handwriting |
before starting the exercise program and after 8weeks of exercise |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
25/07/2018 |
| 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="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The purpose of the study is to evaluate the effect of 8 weeks upper limb pilates exercise in children with poor handwriting and evaluation of children handwriting tool is used for the pre post assessment of the children .
|