| CTRI Number |
CTRI/2025/01/079181 [Registered on: 21/01/2025] Trial Registered Prospectively |
| Last Modified On: |
21/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Examining the Impact of Foot Postural Variations on Ankle Muscle Strength, Balance, and Proprioception in Middle-Aged Women: A Cross-Sectional Analysis |
|
Scientific Title of Study
|
Impact Of Foot Postural Variations on Ankle Muscle Strength, Balance, and Proprioception in Middle-Aged Female: A Cross Sectional 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 |
Zeba Parveen |
| Designation |
PG Student |
| Affiliation |
Jamia Hamdard |
| Address |
Room No.9, Rehabilitation Centre, Department of Physiotherapy, SNSAH, Jamia Hamdard, New Delhi
South
DELHI
110062
India |
| Phone |
9557108060 |
| Fax |
|
| Email |
mzebapar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nishat Quddus |
| Designation |
Head and Associate Professor |
| Affiliation |
Jamia Hamdard |
| Address |
Room No.511, 5th Floor, Central Library Building, Department of Physiotherapy, SNSAH, Jamia Hamdard, New Delhi
South
DELHI
110062
India |
| Phone |
9891544350 |
| Fax |
|
| Email |
nquddus@jamiahamdard.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Mr Zuheb Ahmed Siddiqui |
| Designation |
Assistant Professor |
| Affiliation |
Jamia Hamdard |
| Address |
Room No.534, 5th Floor, Central Library Building, Department of Physiotherapy, SNSAH, Jamia Hamdard, New Delhi
South
DELHI
110062
India |
| Phone |
9810744297 |
| Fax |
|
| Email |
zuhebahmedsiddiqui@jamiahamdard.ac.in |
|
|
Source of Monetary or Material Support
|
| Jamia Hamdard, Hamdard Nagar, New Delhi - 110062 |
|
|
Primary Sponsor
|
| Name |
Jamia Hamdard |
| Address |
Hamdard Nagar, New Delhi - 110062 |
| 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 |
| Dr Nishat Quddus |
Jamia Hamdard |
Room No 9,
Rehabilitation Centre,
Department of Physiotherapy, SNSAH
South
DELHI |
9891544350
nquddus@jamiahamdard.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Jamia Hamdard, Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
1.Pes Planus/Flat foot
2. Pes Cavus/High Arched Foot |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Female |
| Details |
1. Subjects with medial longitudinal arch height of foot measuring 6-9 mm on Navicular Drop Test.
2. Subjects with medial longitudinal arch height of foot measuring more than 10 mm on Navicular Drop Test
3. Subjects willing to participate voluntarily.
|
|
| ExclusionCriteria |
| Details |
1. Subjects with congenital abnormalities in the lower limbs
2. Subjects with severe trunk or spinal deformities such as scoliosis, hyperkyphosis etc.
3. Subjects having history of trauma or pain in any form in feet, lower limbs in last 12 months.
4. Subjects with history of neurologic, rheumatic, or metabolic diseases.
5. Hemodynamically unstable patients
6. Subjects having pain and swelling near ankle and foot
7. Subjects on medications that can alter balance testing
8. Subjects who underwent a surgery of the lower limb in last 6 months.
9. Subjects with a history of balance or vestibular disorders.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.FOOT POSTURE: Navicular Drop Test
2.MUSCLE STRENGTH: Isokinetic Dynamometer
3.BALANCE: Static and Dynamic by using Humac Balance System (CSMi)
|
At Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| PROPRIOCEPTION: Joint Position sense |
At Baseline |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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)
|
01/02/2025 |
| 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="3"
Days="15" |
|
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
|
Subjects will be invited to participate in the research at the Rehabilitation Center, Jamia Hamdard. Upon arrival they will be explained about the research and procedures and will undergo a screening process, assessing different foot postures using the Navicular Drop Test. From this process, a total of 140 middle-aged female participants will be selected to examine the impact of foot postural variations on ankle muscle strength, balance, and proprioception. The participants will be divided into two groups based on their foot posture: Group 1 (flat foot) with and Group 2 (normal foot). Participants will be included based on the selection criteria based on specific inclusion criteria, undergoing a navicular drop test to assess foot posture. Patients meeting the selection criteria will be then recruited for the study and asked to sign an informed consent form, confirming their willingness to participate, and acknowledging their rights, including confidentiality and the ability to withdraw from the study at any time. Following the consent process, participants will undergo assessments for muscular strength, proprioception, and balance as outlined in the study protocol. Balance will be evaluated using the HUMAC Balance System, which provided detailed metrics on stability through a series of tasks. Joint position sense will be measured with an isokinetic dynamometer, requiring participants to replicate demonstrated joint angles while blindfolded to eliminate visual cues. Muscle strength of the ankle will be assessed using the isokinetic dynamometer, focusing on ankle inversion, eversion, dorsiflexion, and plantarflexion, with peak torque recorded for analysis. After all measurements are taken, the data will be interpreted to identify patterns and correlations. Participants will be then given personalized feedback on how to improve their foot posture, balance, and muscle strength through specific exercises and lifestyle changes, aimed at enhancing their overall quality of life. |