| CTRI Number |
CTRI/2024/05/067103 [Registered on: 09/05/2024] Trial Registered Prospectively |
| Last Modified On: |
11/05/2024 |
| 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
|
A clinical study evaluating the Star Excursion Balance Tests reference value and usefulness in treating and diagnosing balance and fall among older persons. |
|
Scientific Title of Study
|
Reference value of the Star Excursion Balance Test and its efficacy as a diagnostic and rehabilitative tool among older adults. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sharnpreet Kaur |
| Designation |
PhD Scholar |
| Affiliation |
MYAS-GNDU, Department of Sports Sciences and Medicine, Guru Nanak Dev University, Amritsar, Punjab |
| Address |
Department of Physiotherapy, GNDU, Amritsar, Punjab.
Amritsar
PUNJAB
143005
India |
| Phone |
9877781036 |
| Fax |
|
| Email |
sharnprt22@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Sarika |
| Designation |
Assistant Professor |
| Affiliation |
Guru Nanak Dev University, Amritsar, Punjab |
| Address |
MYAS-GNDU, Department of Sports Sciences and Medicine, GNDU, Amritsar, Punjab.
Amritsar
PUNJAB
143005
India |
| Phone |
9877781036 |
| Fax |
|
| Email |
sarika.myas@gndu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Sharnpreet Kaur |
| Designation |
PhD Scholar |
| Affiliation |
Guru Nanak Dev University, Amritsar, Punjab |
| Address |
Department of Physiotherapy, GNDU, Amritsar, Punjab.
Amritsar
PUNJAB
143005
India |
| Phone |
9877781036 |
| Fax |
|
| Email |
sharnprt22@gmail.com |
|
|
Source of Monetary or Material Support
|
| Health centre of Guru Nanak Dev University, Amritsar |
|
|
Primary Sponsor
|
| Name |
Guru Nanak Dev University |
| Address |
MYAS-GNDU, Department of Sports Sciences and Medicine, Guru Nanak Dev University, Amritsar |
| Type of Sponsor |
Other [Research and Educational Institute ] |
|
|
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 Sharnpreet Kaur |
Guru Nanak Dev University |
Physiotherapy Centre/ Physiotherapy Room of Health Centre of Guru Nanak Dev University
Amritsar
PUNJAB
Amritsar
PUNJAB |
9877781036
sharnprt22@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Guru Nanak Dev University, Amritsar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy population |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control Group |
In the control group, the participants will follow their routine for 6 weeks.
Total duration 6 weeks |
| Intervention |
Star Excursion balance test training |
SEBT training: 4 sessions per week, overall duration will be 6 weeks.
Total duration: 6 weeks |
|
|
Inclusion Criteria
|
| Age From |
55.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy older adults with an age between 55-65 years.
2. Participants must not have had any recent lower limb injuries.
3. Completely read and sign the consent form.
|
|
| ExclusionCriteria |
| Details |
1. Not satisfying the mentioned age group.
2. Subjects have undergone any surgery,
3. Subjects with history inner ear problems,
4. Subjects having any type of neurological/cognitive impairment/musculoskeletal disorder, or injury that can affect the outcome of the study.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Static balance, Dynamic balance, Fall efficacy scale, Activity-specific confidence scale, Berg balance scale, Limb length. |
At baseline and after 6 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Anthropometric detail of the participants. |
At baseline. |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
20/05/2024 |
| 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="1"
Days="15" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Balance is an important consideration for older populations. Balance disorders are the most common causes of falls in older adults and often lead to injury, disability, loss of independence, and limitations in quality of life. Falls are also associated with significant morbidity and mortality in the older population and are the most common cause of accidental death and nonfatal accidental injury. In clinical setting various test are available which can be used to assess the balance deficits, SEBT is one of them, which used to assess the balance deficits in young adults. It is reliable and valid measure of dynamic balance deficits, but its application in older population is not more available in literature and don’t have reference value. So, the current study will make an attempt to obtain reference value, it will identify the individual who are more susceptible to injury due to balance issues. Furthermore, the Star excursion balance test was designed for rehabilitation purposes; yet, to my knowledge, no research has used SEBT as a rehabilitation tool. Because of this, the current study uses it as rehabilitation among older adults to determine whether or not it lowers the chance of falling and enhances balance. |