| CTRI Number |
CTRI/2024/03/063866 [Registered on: 08/03/2024] Trial Registered Prospectively |
| Last Modified On: |
07/03/2024 |
| 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
|
Effectiveness of strengthening exercises on plantar pressure in the population having flat foot
|
|
Scientific Title of Study
|
Immediate changes in the plantar pressure after the strengthening exercises in the
population having flat foot
|
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Soubhagyabati Prusty |
| Designation |
Student Researcher |
| Affiliation |
Lovely Professional University |
| Address |
Lovely Professional University Punjab pin code 144411 room no 105 block 3 department of physiotherapy
Jalandhar
PUNJAB
144411
India |
| Phone |
9853845664 |
| Fax |
|
| Email |
soubhagyabati.prusty@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sakshi Sadhu |
| Designation |
Assistant Professor |
| Affiliation |
Lovely Professional University |
| Address |
Lovely Professional University Punjab pin code 144411 room no 105 block 3 department of physiotherapy
Jalandhar
PUNJAB
144411
India |
| Phone |
9596857767 |
| Fax |
|
| Email |
sakshi.22851@lpu.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Soubhagyabati Prusty |
| Designation |
Student Researcher |
| Affiliation |
Lovely Professional University |
| Address |
Lovely Professional University Punjab pin code 144411 room no 105 block 3 department of physiotherapy
Jalandhar
PUNJAB
144411
India |
| Phone |
9853845664 |
| Fax |
|
| Email |
soubhagyabati.prusty@gmail.com |
|
|
Source of Monetary or Material Support
|
| Lovely Professional University |
|
|
Primary Sponsor
|
| Name |
Lovely Professional University |
| Address |
Department of physiotherapy Lovely professional university |
| Type of Sponsor |
Research institution |
|
|
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 Soubhagyabati Prusty |
Lovely Professional University |
Jalandhar Delhi, Grand Trunk Road, Phagwara, Punjab 144001, Department of Physiotherapy
block no 3, room no 105, physiotherapy OPD
Jalandhar
PUNJAB |
9853845664
soubhagyabati.prusty@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITEE LOVELY PROFESSIONAL UNIVERSITY |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy participants having flat foot identified by using foot posture index |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Home based program |
Normal daily activities,3 days for 1 week |
| Intervention |
Tailored strengthening program (TSP) |
3 days protocol, 60 minutes time duration with moderate intensity: Fanning of toes with inversion, Heel strike with toe curl, Heel raise and twist,Ball hold and press,Theraband pull,Ball lifts,Knee folds with ankle flexed,Theraband pulling with inversion,Toe dragging with inversion,Fanning of toes with plantar flexion and toe curl |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1. Age group between 18 and 25 year old
2. Population identified having flatfoot with FPI
3. Both male and female population will be included
4. Flexible and Rigid Both flat foot population will be included
|
|
| ExclusionCriteria |
| Details |
1. Population below 18 years and above 25 years
2. Lower limb fracture cases last 3 months
3. Known case of Diabetic neuropathy
4. Known case of any Neurological problem
5. Known case of Musculoskeletal problem Osteoarthritis Rheumatoid arthritis Gout etc.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To asses the Immediate Changes in the Plantar Pressure of the Participants having Flat foot After intervention |
6 contrasts for 3 days pre and post intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Clark angle
staheli plantar arch index
chippaux smirak index |
2 contacts |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/03/2024 |
| 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="6"
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
|
The study will be divided into 2 phases First phase of
the study: Prevalence study: Population will be
invited on the large scale on the basis of inclusion
and exclusion criteria
after the ethical
approval. The participants will be screened
with the help of Foot Posture Index and categorised accordingly into
normal foot, flat foot or curved foot. Phase 2: The second phase of our study will be Pilot and
randomized control trail including the treatment group and control group. After the initial screening the sample having flat foot
will be selected and randomly divided into two groups Group A: Experimental group and Group
B: Control Group. All the participants will be assessed thoroughly and the
baseline measurements will be recorded (Plantar pressure, staheli plantar arch index, Chippaux- Smirak index,
Clarke’s angle). The experiment group will be provided with exercise
session of 60 minutes after the baseline measurement and the same outcomes will be recorded
again after session,
same will be continued till three days for both the groups. In
control group no exercise session will be given only measurements will be
taken after 60 minutes. All the readings will be compared mean difference will
be calculated between pre and post readings and also from day
1 to Day 3 and any significant
changes will be studied.
|