| CTRI Number |
CTRI/2024/04/065026 [Registered on: 01/04/2024] Trial Registered Prospectively |
| Last Modified On: |
27/03/2024 |
| 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
|
Effectiveness of functional pattern training in improving trunk stability in elderly population
elderly population. |
|
Scientific Title of Study
|
“EFFECTIVENESS OF FUNCTIONAL PATTERN TRAINING IN
IMPROVING TRUNK STABILITY IN ELDERLY POPULATION†|
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Soniya K |
| Designation |
MPT student |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Sri Ramachandra Institute of Higher Education and Research (Deemed to be University)
faculty of physiotherapy [OPD]
No 1 Ramachandra Nagar Porur Chennai 600 116 Tamil Nadu
Sri Ramachandra Institute of Higher Education and Research (Deemed to be University)
faculty of physiotherapy [OPD] No 1 Ramachandra Nagar Porur Chennai 600 116 Tamil Nadu
Chennai
TAMIL NADU
600116
India |
| Phone |
7358567697 |
| Fax |
|
| Email |
t0322009@sriher.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
A Rajarajeswari |
| Designation |
Associate professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Sri Ramachandra Institute of Higher Education and Research (Deemed to be University) No 1
faculty of physiotherapy [OPD] Ramachandra Nagar Porur Chennai 600 116 Tamil Nadu
Sri Ramachandra Institute of Higher Education and Research (Deemed to be University)
faculty of physiotherapy [OPD] No 1 Ramachandra Nagar Porur Chennai 600 116 Tamil Nadu
Chennai
TAMIL NADU
600116
India |
| Phone |
9865802903 |
| Fax |
|
| Email |
rajarajeswari@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
A Rajarajeswari |
| Designation |
Associate professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Sri Ramachandra Institute of Higher Education and Research (Deemed to be University)
faculty of physiotherapy [OPD] No 1 Ramachandra Nagar Porur Chennai 600 116 Tamil Nadu
Sri Ramachandra Institute of Higher Education and Research (Deemed to be University) No 1
faculty of physiotherapy [OPD] Ramachandra Nagar Porur Chennai 600 116 Tamil Nadu
Chennai
TAMIL NADU
600116
India |
| Phone |
9865802903 |
| Fax |
|
| Email |
rajarajeswari@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra Institute of Higher Education and Research (Deemed to be University)
faculty of physiotherapy [OPD] No 1 Ramachandra Nagar Porur Chennai 600 116 Tamil Nadu |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [] |
|
|
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 Soniya K |
Sri Ramachandra Institute of Higher Education and Research(OPD) |
faculty of physiotherapy [OPD] No 1 Ramachandra Nagar Porur Chennai 600 116 Tamil Nadu
Chennai
TAMIL NADU |
7358567697
t0322009@sriher.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee For Students Projects |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Normal individual |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional balance training |
3 days/week for 2 weeks |
| Intervention |
Functional pattern training |
3 days/week for 2 weeks |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
BESTest score of around 60/100 score
Patient who are comprehending and oriented
Ability to maintain sitting posture
Vision within functional limits (deemed adequate for training) |
|
| ExclusionCriteria |
| Details |
Patients with neurological musculoskeletal and vestibular disorders |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Bestest |
2 weeks- pre and post |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not applicable |
Nil |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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)
|
08/04/2024 |
| 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="6"
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
|
Participants will be explained about the procedure of the study and informed consent will be obtained Later participants will be allotted to either interventional and control group by simple random sampling allocation Intervention group will undergo functional pattern training with conventional balance training Control group will undergo conventional balance training Participants will follow this treatment protocol for the 2 weeks The participants will be tested before and after study using BESTest outcome measures |