| CTRI Number |
CTRI/2024/06/068523 [Registered on: 06/06/2024] Trial Registered Prospectively |
| Last Modified On: |
21/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Enhancing lower limb alignment in flexible flatfoot: the impact of comprehensive exercises |
|
Scientific Title of Study
|
Effect of comprehensive exercises on lower limb alignment factors in young adults with flexible flatfoot: 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 |
Disha D Shetty |
| Designation |
Post graduate student |
| Affiliation |
NITTE Institute of Physiotherapy, NITTE(Deemed to be University) |
| Address |
Department of Physiotherapy, Room number 20,second base division, NITTE Institute of Physiotherapy, NITTE(Deemed to be University),Deralakatte, Mangaluru
Dakshina Kannada KARNATAKA 575018 India |
| Phone |
9380198175 |
| Fax |
|
| Email |
shettydisha2018@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Saumya Srivastava |
| Designation |
Associate Professor |
| Affiliation |
NITTE Institute of Physiotherapy, NITTE (Deemed to be University) |
| Address |
Department of Physiotherapy, Room number 20,second base division, NITTE Institute of Physiotherapy, NITTE(Deemed to be University),Deralakatte, Mangaluru
Dakshina Kannada KARNATAKA 575018 India |
| Phone |
9740244077 |
| Fax |
|
| Email |
saumyasri2000@nitte.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Disha D Shetty |
| Designation |
Post graduate student |
| Affiliation |
NITTE Institute of Physiotherapy, NITTE (Deemed to be University) |
| Address |
Department of Physiotherapy, Room number 20,second base division, NITTE Institute of Physiotherapy, NITTE(Deemed to be University),Deralakatte, Mangaluru
Dakshina Kannada KARNATAKA 575018 India |
| Phone |
9380198175 |
| Fax |
|
| Email |
shettydisha2018@gmail.com |
|
|
Source of Monetary or Material Support
|
| NITTE Institute of Physiotherapy, NITTE(Deemed to be University), Deralakatte, Mangaluru, Karnataka-575018, India will provide basic infrastructure facilities, no other monetary support is required |
|
|
Primary Sponsor
|
| Name |
NITTE Institute of Physiotherapy NITTE Deemed to be University |
| Address |
Department of Physiotherapy, room number 20,second base division,NITTE institute of physiotherapy
,NITTE (deemed to be university),Deralakatte,Mangaluru,Karnataka-575018,India |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Disha D Shetty |
Justice K S Hegde Charitable Hospital |
Department of physiotherapy, Room number 20, second base division, NITTE Institute of physiotherapy, NITTE (Deemed to be University), Deralakatte, Mangaluru, 575018 Dakshina Kannada KARNATAKA |
9380198175
shettydisha2018@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of NITTE Institute of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Comprehensive exercise program |
This is a single-group pre-post-intervention study.
After posture analysis of all participants via GaitOn software, a posture analysis system, a comprehensive exercise program will be administered, which includes short foot exercises, foot supination exercise, hip abductor exercise, and wall squats.
Exercises will be progressed after 2 weeks with alteration in the position (ie., sitting, standing, and single-leg stance) and/or an increase in hold time and number of repetitions.
The intervention will be performed at three sessions per week for 8 weeks.
All participants will be required to attend the gait lab /clinic 3 times—at baseline, 4 weeks, and 8 weeks to obtain outcome measures and review the exercises. The obtained values for the lower limb alignment factors will be entered in the data collection sheet.
A comparison of the outcome measures within the group over time (baseline,4 weeks, and 8 weeks) will be performed. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1. BMI within the normal range – 18.5-24.9 kg/m2
2. Navicular drop height of more than 10mm
3. Medial longitudinal arch angle less than 130 degree
|
|
| ExclusionCriteria |
| Details |
1. Pain anywhere in the lower extremity
2. History of any lower extremity surgery
3. History of trauma or accidents to the lower extremities
4. Neurological conditions affecting the lower extremities
5. Congenital deformity of the lower limb
6. Patients with hyperlaxity graded with Beighton score (score of 4-9)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| GaitON software - posture analysis system |
The posture analysis will be performed at baseline, 4 weeks, and 8 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| OHM 3000- plantar pressure system |
The analysis will be performed at baseline, 4 weeks, and 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="27" Sample Size from India="27"
Final Enrollment numbers achieved (Total)= "27"
Final Enrollment numbers achieved (India)="27" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
17/06/2024 |
| Date of Study Completion (India) |
08/02/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
08/02/2025 |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
|
Flat foot, also known as pes planus, is characterized by a reduced curvature of the medial longitudinal arch, causing the entire sole to make close to complete contact with the ground.There exists a variation in the prevalence of flat foot. The likelihood of having flat feet varies with age, sex, body mass index, ethnicity, type of population being investigated, and presence of other associated musculoskeletal pathologies. The prevalence of flat foot in children is high due to ligament laxity, which reduces with age. Among children aged two to six, the prevalence of flexible flat foot ranges from 21 to 57%. In elementary school, the percentage drops to 13–28%. 42% of people between the ages of 11 and 16 have the prevalence, of which 23% have bilateral flat feet and 19% have unilateral flat foot. At least 20% to 30% of young adults have reported having flat feet; the frequency is slightly higher in girls (14.4%) than in boys (12.8%).Although individuals with asymptomatic flexible flatfoot do not report foot pain, discomfort, or fatigue, this condition can impair dynamic foot functions and is also associated with a higher risk of lower limb overuse injuries. A model of biomechanical linkages of the lower extremity in closed-kinetic chain activities hypothesizes that the increased pronation of the foot may have an impact on the movement pattern of proximal joints. Weakness and dysfunction of the hip external rotator may result in hip adduction, medial rotation, and dynamic knee valgus, influencing foot pronation.Weakness in the gluteal muscles can contribute to internal hip joint rotation, leading to foot pronation.Individuals with flat feet exert increased plantar pressure on the midfoot region compared to that of normal foot individuals. Restoring appropriate muscle recruitment patterns and improving strength and performance can be accomplished by reactivating the gluteal muscles.Studies have shown that gluteal strengthening exercises along with foot exercises are effective in decreasing navicular drop and medial plantar pressure and increasing arch height index and static balance. However, there is a lack of good certainty evidence about the effectiveness of comprehensive exercises over entire lower limb alignment factors.GaitON® software is one such 2-D posture analysis system that analyses the standing posture of the patient and identifies key postural deviation from multiple views & exports all data to a report.It is an appropriate evaluation tool for diagnosing initial postural disorders, postural comparisons before and after rehabilitation programs with excellent Inter-rater and Intra-rater reliability: ICC > 0.99 for hip and knee angles.Thus, this study intends to evaluate how a comprehensive exercise program will help in improving the lower extremity alignment of individuals with flexible flatfoot. This research may also help to determine the extent of alterations in the lower limb alignment factors following the initiation of comprehensive exercises for individuals with flexible flatfoot. Our findings may provide a resolution to the challenges associated with determining the role of static lower extremity alignment in increasing the risk of lower extremity injury. Incorporating measures of static lower extremity alignment in prospective study designs will help us identify individuals at greatest risk of injury and contribute to the development of more effective intervention programs to mitigate such risks. Thus, this study intends to evaluate how a comprehensive exercise program will help in improving the lower extremity alignment of individuals with flexible flatfoot. This research may also help to determine the extent of alterations in the lower limb alignment factors following the initiation of comprehensive exercises for individuals with flexible flatfoot. Our findings may provide a resolution to the challenges associated with determining the role of static lower extremity alignment in increasing the risk of lower extremity injury. Incorporating measures of static lower extremity alignment in prospective study designs will help us identify individuals at greatest risk of injury and contribute to the development of more effective intervention programs to mitigate such risks. |