| CTRI Number |
CTRI/2025/03/081788 [Registered on: 06/03/2025] Trial Registered Prospectively |
| Last Modified On: |
04/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
To conpare between Motor-Motor dual task training and Motor Congnitive dual task training on dynamic balance among overweight flat feet collegiate students- an interventional study |
|
Scientific Title of Study
|
Comparision of motor motor dual task training versus motor cognitive dual task training on dynamic balance among overweight flat feet collegiate students- an interventional 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 |
Surekha C |
| Designation |
PG Scholar |
| Affiliation |
Alvas College of Physiotherapy |
| Address |
Alvas college of Physiotherapy Moodbidri dakshina kannada karnataka India
Alva Physiotherapy OPD
Moodbidri Dakshina kannada
Alvas college of Physiotherapy Moodbidri dakshina kannada karnataka India
Alva Physiotherapy OPD
Moodbidri Dakshina kannada
Dakshina Kannada KARNATAKA 574227 India |
| Phone |
9535826616 |
| Fax |
|
| Email |
Gedruarayamebhin@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Srinivasan S |
| Designation |
Associate Professor |
| Affiliation |
Alvas College of Physiotherapy |
| Address |
Alvas college of Physiotherapy Moodbidri dakshina kannada karnataka India
574227
Alvas college of Physiotherapy Moodbidri dakshina kannada karnataka India
574227
Dakshina Kannada KARNATAKA 574227 India |
| Phone |
9789906015 |
| Fax |
|
| Email |
Vasanpt@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Surekha C |
| Designation |
PG Scholar |
| Affiliation |
Alvas College of Physiotherapy |
| Address |
Alvas college of Physiotherapy Moodbidri dakshina kannada karnataka India
574227
Alvas college of Physiotherapy Moodbidri dakshina kannada karnataka India
574227
Dakshina Kannada KARNATAKA 574227 India |
| Phone |
9535826616 |
| Fax |
|
| Email |
Gedruarayamebhin@gmail.com |
|
|
Source of Monetary or Material Support
|
| Alvas college of physiotherapy outpatient department,moodbidr, dakshina kannada karnataka
Alvas college of Physiotherapy,moodbidr ,dakshina kannada district, karnataka, India
Pincode- 574227
Wall mounted one meter ruler,sheet of paper, small ruler 15cm |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [Nil] |
|
|
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 |
| DrHariharasudhan ravichandran |
Alvas health centre, moodbidri |
Alvas neuro outpatient department
Alvas college of physiotherapy, moodbidri, Dakshin kannada, karnataka Dakshina Kannada KARNATAKA |
9789906015
hrkums63@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board of Alvas College of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Flat foot |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Motor congitive dual task |
Group B Warm up period
Exercise-participants will complete congitive activity while standing on a balance pod with their eyes open. The task include counting down numbers, days of the week and months of the year, while writing proper names backwards and remembering the word lists sequence for ten
Minutes
2 times in a week treatment will be given for total duration of 45 minutes cool down period |
| Intervention |
Motor motor dual task training
|
Group A- motor motor dual task training
Warm up period
Exercise- subjects will standing on balancing pod while catching and tossing ball( with the right, left or both hands) with two individuals standing face to face 1.5 meters apart, doing tasks under all three scenarios
2 times in a week treatment will be given for total duration of 45 minutes
Cool down period
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Female |
| Details |
BMI- 25-29.9;functional reach test; adults with flexible flat feet; students will to participate |
|
| ExclusionCriteria |
| Details |
Lower extremity abnormalities;adults with flat feet and pain; reduction of ankle inversion eversion;Adults with MMSE less than 24 |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Functional reach test
Navicular drop test sit to stand |
Baseline data collection 20 mins
Post baseline data collection after 4 weeks for 20 mins |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="42" Sample Size from India="42"
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)
|
28/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
28/03/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0" Months="3" 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 will be conducted to compare the effects of motor motor dual task training and motor cognitive dual task training on dynamic balance among overweight collegiate students with flat feet.42 female participants with flatfoot and overweight were selected from the colleges. participants will be screened according to selection criteria, participants will be randomly allocated to two experimental groups. Pre outcome measure scores will be taken from all participants and after 4 weeks of intervention post outcome measure score will be obtained. Data will be analysed using SPSS software. |