| CTRI Number |
CTRI/2025/04/084838 [Registered on: 15/04/2025] Trial Registered Prospectively |
| Last Modified On: |
15/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effectiveness of Balance Training with a Special Device to Improve Stability in Older Adults |
|
Scientific Title of Study
|
Efficacy of Perturbation Training using Balance Perturbator on Postural Sway among Geriatric 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 |
Rizwana Begum |
| Designation |
PG student |
| Affiliation |
SRM Institute of Science and Technology |
| Address |
SRM College of Physiotherapy,
4th floor, SRM Medical College building, SRM Institute of Science and Technology, Kattankulathur
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9004807912 |
| Fax |
|
| Email |
rb4579@srmist.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suresh J |
| Designation |
Associate Professor |
| Affiliation |
SRM Institute of Science and Technology |
| Address |
SRM College of Physiotherapy, 5th floor, SRM Medical College building, SRM Institute of Science and Technology, Kattankulathur
Kancheepuram
TAMIL NADU
603 203
India |
| Phone |
919698642928 |
| Fax |
|
| Email |
sureshj@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suresh J |
| Designation |
Associate Professor |
| Affiliation |
SRM Institute of Science and Technology |
| Address |
SRM College of Physiotherapy, 5th floor, SRM Medical College building, SRM Institute of Science and Technology, Kattankulathur
Kancheepuram
TAMIL NADU
603 203
India |
| Phone |
919698642928 |
| Fax |
|
| Email |
sureshj@srmist.edu.in |
|
|
Source of Monetary or Material Support
|
| SRM College of Physiotherapy,
4th floor, SRM Medical College building, SRMIST, Kattankulathur, Kancheepuram, Tamilnadu, India-603 203 |
|
|
Primary Sponsor
|
| Name |
Rizwana Begum |
| Address |
SRM College of Physiotherapy,
PT 22, 4th floor, SRM Medical College building, SRM Institute of Science and Technology, Kattankulathur, Kancheepuram, Tamilnadu, India- 603 203 |
| 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 |
| Rizwana Begum |
SRM Medical College Hospital and Research Centre |
Room no. 20, 1st floor, C block, Physiotherapy Department, SRM Institute of Science and Technology, Kattankulathur
Kancheepuram
TAMIL NADU |
9004807912
rb4579@srmist.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM Medical College Hospital and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Geriatric Population |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Perturbation Training |
Perturbation Training using a Balance Perturbator for 6 weeks with 2 sessions per week. Each session comprising of 8 random perturbations in linear and diagonal directions. |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Geriatric individuals with osteoarthritis of the knee joint will be included. Community dwelling older adults with scores more than or equal to 13.5 seconds on Timed up and Go(TUG) test |
|
| ExclusionCriteria |
| Details |
Diagnosed with Vertigo
Recent fractures
Cardiorespiratory Diseases Neurological/Neuromuscular disorders
Any Musculoskeletal condition/disease
Any cognitive impairment/Psychological disorder
Any communication impairment |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Postural Sway measures like Sway path and Sway velocity of the Centre of Pressure(COP) |
Week 1 and Week 6 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Timed Up and Go (TUG) test |
Week 1 and Week 6 |
| Falls Efficacy Scale-International |
Week 1 and Week 6 |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 1 |
|
Date of First Enrollment (India)
|
06/05/2025 |
| 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="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
|
Participants will be selected based on inclusion and exclusion criteria, with informed consent obtained in their regional language. They will wear a safety harness to prevent falls during perturbation training. The Balance Perturbator device will use a perturbation intensity of 3 m/s² and an 18 cm displacement, based on existing safety and efficacy research. The intervention will last six weeks, with two sessions per week involving random perturbations in multiple directions. Postural sway will be measured using force plates and pressure sensors in the device.
|