| CTRI Number |
CTRI/2024/11/076202 [Registered on: 04/11/2024] Trial Registered Prospectively |
| Last Modified On: |
26/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
This is the study to find out the relationship between balance and core endurance in individuals with flexible flatfoot |
|
Scientific Title of Study
|
To study the relationship between balance and core endurance in flexible flatfoot |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shikha PT |
| Designation |
Assistant professor |
| Affiliation |
Saket college of physiotherapy, Chandimandir, Panchkula, Haryana |
| Address |
Room no.66, First floor in physiotherapy department. Saket college of physiotherapy, Chandimandir, Panchkula, Haryana
Panchkula
HARYANA
134107
India |
| Phone |
7419114943 |
| Fax |
|
| Email |
dr.shikha.ins@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shikha PT |
| Designation |
Assistant professor |
| Affiliation |
Saket college of physiotherapy, Chandimandir, Panchkula, Haryana |
| Address |
Room no.66 First floor in physiotherapy department of Saket college of physiotherapy, Chandimandir, Panchkula, Haryana
Panchkula
HARYANA
134107
India |
| Phone |
7419114943 |
| Fax |
|
| Email |
dr.shikha.ins@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prera Sharma |
| Designation |
MPT student |
| Affiliation |
Saket college of physiotherapy, Chandimandir, Panchkula, Haryana |
| Address |
Room No. 53, Ground floor in physiotherapy department in Saket college of physiotherapy, Chandimandir, Panchkula, Haryana
Panchkula
HARYANA
134107
India |
| Phone |
08059429922 |
| Fax |
|
| Email |
prerasharma20@gmail.com |
|
|
Source of Monetary or Material Support
|
| I will myself bear the cost required. Address - PRERA SHARMA, MPT student,
Address - Saket college of physiotherapy, Chandimandir, Panchkula, Haryana, India.
Pincode- 134107 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [] |
|
|
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 |
| Prera Sharma |
Saket College of Physiotherapy, Chandimandir, Panchkula. |
Room No. 53, Ground floor in physiotherapy department in Saket college of physiotherapy, Chandimandir, Panchkula, Haryana
Panchkula
HARYANA |
8059429922
prerasharma20@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Flexible Flat foot |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Individuals with bilateral flexible flatfeet with 10mm difference or more on NDT
(Navicular Drop Test). |
|
| ExclusionCriteria |
| Details |
1. History of lower extremity injury within last 6 months.
2. History of lower extremity surgery
3. Congenital deformity in lower extremity or trunk
4. Musculoskeletal, neurological, vestibular condition affecting balance or proprioception
5. Postural abnormalities
6. Limb length discrepancy
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 SIT TO STAND NAVICULAR DROP(ND) TEST
2 UNIPEDAL STANCE TEST TO ASSESS STATIC BALANCE
3 SEBT (STAR EXCURSION BALANCE TEST) TO ASSESS DYNAMIC
BALANCE
4 CORE ENDURANCE
a MODIFIED FLEXION TEST[
b MODIFIED EXTENSION TEST
c LATERAL MUSCLE TEST |
1. Base line data
2 post observational data |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
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)
|
12/11/2024 |
| 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
|
Flexible flatfoot is defined as the postural appearance of the foot, with depressed medial
longitudinal arch, pronated subtalar joint and medial rotation and plantar flexion of the talus,
eversion of the calcaneus & abduction of forefoot underweight bearing conditions. Flexible flat
foot is a common musculoskeletal disorder which affects the biomechanics of the lower limb
and further leads to the consequences of incoordination, imbalance, reduced muscle strength
and reduced postural stability. It increases the risk of lower limb injuries, spinal deformities
and pelvic instability. The feet are the distal part of lower kinetic chain and even a small
dynamic change affects the control of body position, thus affecting the balance.
The aim of this study is to find the relationship between balance and core endurance in subjects
with flexible flatfoot. The objectives of the study are to assess the static balance of individuals
with flexible flatfoot, to assess the dynamic balance of individuals with flexible flatfoot, to
assess the core endurance of individuals with flexible flatfoot, to find the relationship between
balance and core endurance in individuals with flexible flatfoot.
This is a cross sectional study. Convenient sampling method will be used. Subjects will
undergo through the screening program by using the Assessment Performa. Individuals who
will fulfill the inclusion criteria will be allowed to participate in this study and informed consent
will be signed by the individuals. Demographics variables will be noted which will include the
subject’s age, gender, height, weight, address and occupation. For assessing flexible flatfoot,
sit to stand navicular drop test will be performed. To assess the static balance Unipedal stance
test and to assess dynamic balance SEBT (Star excursion balance test) will be used. To assess
core endurance modified flexion, extension and side bridge test will be used. |