| CTRI Number |
CTRI/2025/07/090481 [Registered on: 08/07/2025] Trial Registered Prospectively |
| Last Modified On: |
03/07/2025 |
| 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
|
Study on improving balance in people with flexible flatfeet using core strengthening exercises with and without vibration platform |
|
Scientific Title of Study
|
Effect of lumbar stabilisation exercises performed with and without whole body vibration platform on postural control in flexible flatfeet : An experimental 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 |
Sakshi Sachin Shah |
| Designation |
Post Graduate Student |
| Affiliation |
Dr. D. Y. Patil College of Physiotherapy, Pimpri, Pune |
| Address |
Musculoskeletal Department, 3rd Floor, Dr.D.Y.Patil College Of Physiotherapy, Dr.D.Y.Patil Vidyapeeth, Sant Tukaram Nagar, Pimpri, Pune, Maharashtra 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9987682644 |
| Fax |
|
| Email |
sakshishah971@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Roopa Desai |
| Designation |
Professor |
| Affiliation |
Dr. D. Y. Patil College of Physiotherapy, Pimpri, Pune |
| Address |
Musculoskeletal Department, 3rd Floor, Dr.D.Y.Patil College Of Physiotherapy, Dr.D.Y.Patil Vidyapeeth, Sant Tukaram Nagar, Pimpri, Pune, Maharashtra 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9890992383 |
| Fax |
|
| Email |
roopa.desai@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Sakshi Sachin Shah |
| Designation |
Post Graduate Student |
| Affiliation |
Dr. D. Y. Patil College of Physiotherapy, Pimpri, Pune |
| Address |
Musculoskeletal Department, 3rd Floor, Dr.D.Y.Patil College Of Physiotherapy, Dr.D.Y.Patil Vidyapeeth, Sant Tukaram Nagar, Pimpri, Pune, Maharashtra 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9987682644 |
| Fax |
|
| Email |
sakshishah971@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. D. Y. Patil College of Physiotherapy, Dr.D.Y.Patil Vidyapeeth, Sant Tukaram Nagar, Pimpri, Pune, Maharashtra 411018 |
|
|
Primary Sponsor
|
| Name |
Sakshi Sachin Shah |
| Address |
Dr. D. Y. Patil College of Physiotherapy,Dr.D.Y.Patil Vidyapeeth, Sant Tukaram Nagar, Pimpri, Pune, Maharashtra 411018 |
| Type of Sponsor |
Other [Self Funded] |
|
|
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 Sakshi Sachin Shah |
Dr. D. Y. Patil College of Physiotherapy Out Patient Department |
Outpatient Department, Ground Floor, Dr.D.Y. Patil College of Physiotherapy, Dr.D.Y.Patil Vidyapeeth, Sant Tukaram Nagar, Pimpri, Pune, Maharashtra 411018
Pune
MAHARASHTRA |
9987682644
sakshishah971@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC) |
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
|
| Type |
Name |
Details |
| Comparator Agent |
Lumbar Stabilisation Exercises |
Group B (Comparator Group): Participants will perform the same lumbar stabilisation exercises without the vibration platform.
Exercises Included (for both groups):
Squats
Lunges
Flanks
Curl-ups
Bridges
Bridges with knee extension
Warm-up and Cool-down Protocol:
Each session will begin and end with 10 minutes of stretching.
Repetitions and Sets:
5 repetitions per set
Each set lasts 10 seconds
Total of 5 sets per session
Rest Period:
20 seconds of rest between each set
Frequency of Sessions:
3 sessions per week
Total Program Duration:
8 weeks |
| Intervention |
Lumbar Stabilisation Exercises with whole body vibration |
Group A (Intervention Group): Participants will perform lumbar stabilisation exercises on a whole-body vibration (WBV) platform.
Exercises Included (for both groups):
Squats
Lunges
Flanks
Curl-ups
Bridges
Bridges with knee extension
Warm-up and Cool-down Protocol:
Each session will begin and end with 10 minutes of stretching.
Repetitions and Sets:
5 repetitions per set
Each set lasts 10 seconds
Total of 5 sets per session
Rest Period:
20 seconds of rest between each set
Frequency of Sessions:
3 sessions per week
Total Program Duration:
8 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1 Individuals with Flexible Flatfeet
2 Individuals having anterior pelvic tilt greater than 19 degree
3 Navicular Drop Test greater than or equal to 10mm
4 Jack test
|
|
| ExclusionCriteria |
| Details |
1 No prior lower extremity deformity
2 No history of lower limb or spinal surgery
3 Any Neurological Deficit
4 Vestibular disorders
5 Obesity
6 Pregnancy
7 Cardiovascular disease
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 Static Postural Control Using Unilateral Stance on Balance Master
2 Dynamic Postural Control Using components of Limits Of Stability on Balance Master
|
Baseline Assessment and Post intervention assessment after 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 Pelvic Alignment – Using Digital Pelvic Inclinometer
2 Navicular Depth– Navicular Drop Test
3 Foot Posture – Foot Posture Index FPI-6
|
Baseline Assessment and Post intervention assessment after 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "70"
Final Enrollment numbers achieved (India)="70" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
18/07/2025 |
| Date of Study Completion (India) |
02/03/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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 flat feet are associated with impaired postural control, altered lower limb biomechanics, and an increased risk of injuries due to excessive subtalar pronation, which affects the kinetic chain and leads to compensatory stress on the lower back. Lumbar stabilization exercises help improve spinal stability, activate deep core muscles, and enhance motor performance. Whole body vibration (WBV), when combined with these exercises, may further improve muscle activation, sensory-motor control, and neuromuscular coordination. This experimental study aims to evaluate and compare the effects of lumbar stabilization exercises performed with and without WBV on postural control, pelvic alignment, navicular depth, and foot posture in individuals with flexible flat feet. A total of 70 participants will be enrolled using a convenient sampling method and randomly assigned to either the intervention group (exercises with WBV) or control group (exercises without WBV), with all sessions conducted for 8 weeks at Dr. D.Y. Patil College of Physiotherapy, Pimpri, Pune. |