| CTRI Number |
CTRI/2022/10/046256 [Registered on: 07/10/2022] Trial Registered Prospectively |
| Last Modified On: |
06/10/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Relationship Of Lower Limb Muscle Strength And Physical Performance In Adults With Flat Foot |
|
Scientific Title of Study
|
Relationship Of Lower Limb Muscle Strength And Physical Performance In Adults With Flexible Pes Planus |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Soumyaa P Gandhi |
| Designation |
Postgraduate Student |
| Affiliation |
Sancheti Institute College of Physiotherapy |
| Address |
1st Floor, Musculoskeletal Department, Sancheti Institute College of Physiotherapy, 11/12 Thube Park, Shivajinagar,Pune
Pune
MAHARASHTRA
411005
India |
| Phone |
9869796967 |
| Fax |
|
| Email |
soumyaa.sg@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Venu Mohan |
| Designation |
Associate Professor |
| Affiliation |
Sancheti Institute College of Physiotherapy |
| Address |
1st Floor, Musculoskeletal Department, Sancheti Institute College of Physiotherapy, 11/12 Thube Park, Shivajinagar,Pune
Pune
MAHARASHTRA
411005
India |
| Phone |
9440690707 |
| Fax |
|
| Email |
venumohan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Venu Mohan |
| Designation |
Associate Professor |
| Affiliation |
Sancheti Institute College of Physiotherapy |
| Address |
1st Floor, Musculoskeletal Department, Sancheti Institute College of Physiotherapy, 11/12 Thube Park, Shivajinagar,Pune
Pune
MAHARASHTRA
411005
India |
| Phone |
9440690707 |
| Fax |
|
| Email |
venumohan@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sancheti Institute College of Physiotherapy |
| Address |
11/12 Thube Park, Shivajinagar, Pune-411005 |
| 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 |
| Soumyaa Gandhi |
Sancheti Institute for orthopaedics and Rehabilitation |
11/12, thube park, shivajinagar, Pune -411005
Pune
MAHARASHTRA |
020-25539393
soumyaa.sg@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Sancheti Institute College of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M214||Flat foot [pes planus] (acquired), |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1.Adults (18-30-year-olds)
2.Individuals with flexible pes planus and neutral arched feet |
|
| ExclusionCriteria |
| Details |
1. Obese individuals (BMI≥30)
2. History of lower extremity pain or surgery,
3. Neurological, orthopedic and vestibular impairments that can affect
balance and gait
4. Any co-morbidities
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
-Hip, Knee and Ankle muscle strength using MicroFET dynamometer
-30 second sit to stand test
-BESS test
-Modified Star Excursion Test
-20m Walk Test |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="78"
Sample Size from India="78"
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)
|
16/10/2022 |
| 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
|
“none yet†|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
There will be two groups. One will have individuals with flexible pes planus (assessed using Navicular drop test and navicular drop distance calculated) and other will have individuals with normal arched feet (of similar age and BMI) Strength of hip, knee and ankle muscle groups will be measured using a dynamometer. Physical performance will be assessed using 30 second sit-to-stand test, BESS Test, modified star excursion test and 20m walk Test. To find if there is a relationship between lower limb muscle strength and physical performance in each group and compare physical performance between individuals in both groups. |