| CTRI Number |
CTRI/2024/10/075657 [Registered on: 23/10/2024] Trial Registered Prospectively |
| Last Modified On: |
18/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Testing of Electronic Device (Sensors) for Balance Assessment in Healthy Participants and Chronic Ankle Instability Individuals |
|
Scientific Title of Study
|
Reliability and Validity of Inertial Sensors for Static Balance Assessment in Healthy and Chronic Ankle Instability Individuals |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Akshita Lala |
| Designation |
Post Graduate Student (Masters of Physiotherapy) |
| Affiliation |
Indian Spinal Injuries Center Institute of Rehabilitation Sciences |
| Address |
Room no. 3, 2nd floor, Indian Spinal Injuries Centre-Institute of Rehabilitation Sciences (Musculoskeletal Department), Sector C, Vasant Kunj,
New Delhi.
South West
DELHI
110070
India
South West
DELHI
110070
India |
| Phone |
7048903194 |
| Fax |
|
| Email |
lalaakshita2000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Meena Makhija |
| Designation |
Associate Professor |
| Affiliation |
Indian Spinal Injuries Center Institute of Rehabilitation Sciences |
| Address |
Indian Spinal Injuries Center, Institute of Rehabilitation Sciences, Rehabilitation Department, 2nd Floor, Sector C, Vasant Kunj, South Delhi-110070
India
South West
DELHI
110070
India |
| Phone |
9910011816 |
| Fax |
|
| Email |
makhijameena81@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Meena Makhija |
| Designation |
Associate Professor |
| Affiliation |
Indian Spinal Injuries Center Institute of Rehabilitation Sciences |
| Address |
Indian Spinal Injuries Center, Institute of Rehabilitation Sciences, Rehabilitation Department, 2nd Floor, Sector C, Vasant Kunj, South Delhi-110070
India
South West
DELHI
110070
India |
| Phone |
9910011816 |
| Fax |
|
| Email |
makhijameena81@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Spinal injuries centre-Institute of Rehabilitation Sciences, Sector C,Vasant Kunj,New
Delhi,South Delhi,110070,India |
|
|
Primary Sponsor
|
| Name |
N/A |
| Address |
N/A |
| Type of Sponsor |
Other [N/A] |
|
|
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 |
| Akshita Lala |
Indian Spinal injuries Center |
Indian spinal injuries Center, institute of Rehabilitation
sciences, Rehabilitation Department, 2nd Floor, Sector C, Vasant kunj, South Delhi-110070
South West
DELHI |
7048903194
lalaakshita2000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Indian Spinal Injuries Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Asymptomatic individuals with no laxity in ankle and No history of lower extremity or trunk injury that may affect balance
|
| Patients |
(1) ICD-10 Condition: M253||Other instability of joint, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
CAI group: A history of at least one lateral ankle sprain, a history of at least two instances of the affected joint “giving way†or feeling of instability within the past 6 months, Cumberland ankle instability tool (CAIT) score less than 25
Healthy group: Asymptomatic individuals with no laxity and no history of lower extremity or trunk injury that may affect balance |
|
| ExclusionCriteria |
| Details |
Any acute and subacute ankle sprain
Any diagnosed neurological or systemic condition which may affect balance
Uncorrected hearing or visual impairment.
History of spine or lower limb surgery and trauma.
No prior history of balance training
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
RMS: Root Mean Square (Acceleration)
Jerk: Rate of change of acceleration
MV: Mean Velocity
COP ellipse area
COP path length (total distance)
Average COP velocity
Standard deviation and Root mean square COP |
Day 1 baseline test
Day 2 re test (for reliability) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
COP ellipse area
COP path length (total distance)
Average COP velocity
Standard deviation and Root mean square COP |
Day 1 baseline test for validity |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
30/10/2024 |
| 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="7"
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
|
Chronic ankle instability (CAI) is a common condition marked by frequent ankle sprains and a sense of instability, which negatively impacts balance during daily activities. While inertial sensors, known for being portable, cost-effective, and easy-to-use alternatives to force plates, are widely used to assess balance in neurological populations, their use in musculoskeletal conditions like CAI is limited. These sensors have been applied to conditions such as Parkinson’s and multiple sclerosis, but there is little research on their reliability and validity in CAI population. This study aims to fill that gap by investigating the test-retest reliability and validity of wearable inertial sensors in CAI individuals, using sensitive kinematic parameters like Root Mean Square (RMS) acceleration, JERK, and mean velocity. Participants will be enrolled based on the inclusion criteria and then asked to perform (Balance error scoring system) BESS test wearing the sensors on the sacrum and shank. Balance error scoring system is a static balance assessment tool consisting of 3 stance conditions (double leg standing, single leg standing and tandem standing) on 2 surface conditions each (firm and foam surface). Then the balance outcome will first be compared to force plate to validate the sensors, test will be performed again after 24 hrs. to check the reliability. Outcome measure like Root Mean Square Acceleration, JERK (Rate of change of acceleration) and Mean velocity will be assessed 2 times within 24 hrs. interval. Also, the data will be compared to prokin 252 tecnobody with center of pressure (COP) ellipse area, path length and average velocity for validation of inertial sensors. The data collected by the inertial sensors and prokin 252 will be assessed in MATLAB and SPSS windows version will be used in the study. |