| CTRI Number |
CTRI/2025/07/091341 [Registered on: 21/07/2025] Trial Registered Prospectively |
| Last Modified On: |
02/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study on How Long People Can Stand on One Leg. |
|
Scientific Title of Study
|
Normative Value for the Single Leg Stance Test with Eyes Open and Eyes Closed Among Community-Dwelling Healthy Adults Residing at Vadodara City: 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 |
Lafawala Kamilmehdi Ismail bhai |
| Designation |
PG Scholar |
| Affiliation |
KPGU |
| Address |
Neurological & Psychosomatic Department, Krishna School of Physiotherapy and Rehabilitation, Drs. Kiran & Pallavi Global University (KPGU), Vadodara-Mumbai NH8, Varnama, Vadodara, Gujarat 391243, India
Vadodara
GUJARAT
391243
India |
| Phone |
7874785470 |
| Fax |
|
| Email |
klafawala@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Pragna Landge PT |
| Designation |
Associate Professor |
| Affiliation |
KPGU |
| Address |
Neurological & Psychosomatic Department, Krishna School of Physiotherapy and Rehabilitation, Drs. Kiran & Pallavi Global University (KPGU), Vadodara-Mumbai NH8, Varnama, Vadodara, Gujarat 391243, India
Vadodara
GUJARAT
391243
India |
| Phone |
7861805233 |
| Fax |
|
| Email |
pragnalandge.kspr@kpgu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Kamilmehdi Lafawala |
| Designation |
PG Scholar |
| Affiliation |
KPGU |
| Address |
Neurological & Psychosomatic Department, Krishna School of Physiotherapy and Rehabilitation, Drs. Kiran & Pallavi Global University (KPGU), Vadodara-Mumbai NH8, Varnama, Vadodara, Gujarat 391243, India
Vadodara
GUJARAT
391243
India |
| Phone |
7874785470 |
| Fax |
|
| Email |
klafawala@gmail.com |
|
|
Source of Monetary or Material Support
|
| Physiotherapy OPD, Matrushri Davalba Hospital |
|
|
Primary Sponsor
|
| Name |
Lafawala Kamilmehdi |
| Address |
wadi, tai wada, shivaji chowk, navapura, chellu faliyu, vadodara-390017 |
| Type of Sponsor |
Other [Self] |
|
|
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 Kamilmehdi Lafawala |
Physiotherapy OPD, Matrushri Davalba Hospital |
Neurological & Psychosomatic Department, Krishna School of Physiotherapy and Rehabilitation, Drs. Kiran & Pallavi Global University (KPGU), Vadodara-Mumbai NH8, Varnama, Vadodara, Gujarat 391243, India
Vadodara
GUJARAT |
7874785470
klafawala@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Commitee for Biomedical and Health Research, KPGU. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Assessment of static balance |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Age 18-80 years (Healthy adults)
Both male and female
Willing to participate in the study
|
|
| ExclusionCriteria |
| Details |
Known history of balance impairment
Peripheral neuropathy (clinically diagnosed or if they had symptoms of numbness or tingling in the lower extremities)
Orthopaedic lower extremity or lumbosacral conditions requiring consultation with a health care professional (to include ligamentous injuries, osteoarthritis, or joint replacement)
Pain of any level presenting simultaneously in both lower extremities; or unilateral lower extremity pain more than 3 on the 11-point visual analog (box) scale
Pregnant women
History of fainting, vertigo, or dizziness
Current use of medications causing dizziness
Patients having acute or chronic plantar fasciitis
Patient diagnosed with any psychosomatic conditions
Patient taking any psychiatric medicines
History of amputation of upper limb or lower limb
Alcohol or drug abuse
Any professional athlete
Patient using an assistive device (cane, walker, etc)
Labyrinthitis
Individual who are haemodynamically unstable
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find the normative data of single leg stance test |
Immediate |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="990"
Sample Size from India="990"
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)
|
21/07/2025 |
| 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="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
Single leg stance test [SLST] appears to be used often in clinical settings to assess static balance, fall status, gait performance, frailty and self-sufficiency in activities of daily living and also it is reliable test, too. SLST is inexpensive, time-efficient, easy for the examiner to administer it, correlates well with other balancing tests and doesn’t require any specialized equipment. There are available normative values of SLST for Irani, Arabian, Japanese and American population, which may not be accurately reflect for the Indian population, Because of difference from other countries in terms of BMI, height, weight and ethnicity. The purpose of this study is to generate normative values of SLST with eyes open and eyes closed conditions among healthy adults residing at Vadodara and correlate it with by age, gender, BMI to serve as an acceptable reference standard. Thus, the current study will be undertaken to evaluate the normative values of SLST with eyes open and closed among community-dwelling healthy adults. Null hypothesis: There is no significant association between age, gender and BMI with normative values of SLST among community dwelling healthy adults. Alternative hypothesis: There is significant association between age, gender and BMI with normative values of SLST among community dwelling healthy adults. |