| CTRI Number |
CTRI/2025/03/082545 [Registered on: 18/03/2025] Trial Registered Prospectively |
| Last Modified On: |
17/03/2025 |
| 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
|
Effect of Timing and Coordination Exercises on Walking and Movement in Older Adults with Risk of Falling. |
|
Scientific Title of Study
|
Effect of Timing and Coordination Training on Gait Kinematics and Interlimb and Intralimb Coordination in Older Adults with Mild Fall Risk: A Randomised Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Majumi M Noohu |
| Designation |
Professor |
| Affiliation |
Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia |
| Address |
Room No. 105, First Floor Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, New Delhi
New Delhi DELHI 110025 India |
| Phone |
09868023378 |
| Fax |
|
| Email |
mnoohu@jmi.ac.in |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Majumi M Noohu |
| Designation |
Professor |
| Affiliation |
Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia |
| Address |
Room No. 105, First Floor Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, New Delhi
New Delhi DELHI 110025 India |
| Phone |
09868023378 |
| Fax |
|
| Email |
mnoohu@jmi.ac.in |
|
Details of Contact Person Public Query
|
| Name |
Sofiya Hussain |
| Designation |
Student |
| Affiliation |
Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia |
| Address |
Room No. 208, Second Floor Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, New Delhi
New Delhi DELHI 110025 India |
| Phone |
9548334991 |
| Fax |
|
| Email |
Sofiyahus2001@gmail.com |
|
|
Source of Monetary or Material Support
|
| Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, Okhla, New Delhi- 110025 |
|
|
Primary Sponsor
|
| Name |
Jamia Millia Islamia |
| Address |
Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, New Delhi-110025 |
| Type of Sponsor |
Government funding agency |
|
|
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 Majumi M Noohu |
Jamia Millia Islamia |
Centre for Physiotherapy and Rehabilitation Sciences,Jamia Millia Islamia, Jamia Nagar, New Delhi 110025 New Delhi DELHI |
9868023378
mnoohu@jmi.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Jamia Millia Islamia New Delhi 110025 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Older Adults aged 65 years and above with mild fall risk |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control Group |
Subjects will Continue with their Day to Day Activities. |
| Intervention |
Timing and Coordination Training |
This program is based on principles of motor learning that enhance skill or smooth and automatic movement control. This include goal-oriented progressively difficult stepping and walking patterns.
8 weeks protocol
3 times per week alternatively
35-45 minutes per day |
|
|
Inclusion Criteria
|
| Age From |
65.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Older adults with mild fall risk, able to walk autonomously without aid of 2nd person, may utilise walking assistance device like cane, Short-FES cut off score 7-8 out of 28 |
|
| ExclusionCriteria |
| Details |
Subjects depending on walking aid other than cane, any condition or circumstances that may hinder the naturalness of walking during gait recording process such as neurological disorders, visual impairments etc, inability to participate in testing or exercise intervention. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Stance phase%- Swing phase%
Single support%- double support%
Joint angles ( Hip, Knee, Ankle)
Interlimb and Intralimb coordination
Stride length
Step length
Interlimb and Intralimb coordination |
Two points ( Day 1 and after 8 weeks) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
TUG (Timed Up and Go Test)
POMA (Tinetti Performance-Oriented Mobility Assessment) |
Two points ( Day 1 and after 8 weeks) |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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 3 |
|
Date of First Enrollment (India)
|
07/04/2025 |
| 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="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
According to the World Health Organization, the number of people aged 60 and above is expected to rise significantly, with falls being a leading cause of injury-related deaths in this age group. Falls in older adults are often caused by multiple factors, including physiological, musculoskeletal, and environmental influences. Gait abnormalities and impaired movement coordination are key risk factors for falls. Studies suggest that movement variability plays a crucial role in maintaining balance, but excessive or insufficient variability can lead to instability. Traditional exercise programs may not be as effective as task-oriented motor learning exercises, which focus on improving timing and coordination in walking movements. The study aims to analyze gait parameters and coordination in this population and explore whether specialized timing and coordination training can enhance mobility and reduce fall risk. Subjects fulfilling the inclusion and exclusion criteria will be recruited from Jamia Millia Islamia, and informed about the study. Subjects will be explained the purpose, methodology, and possible risks of the study. They will be given a written informed consent form explaining their rights as research subjects. Risk of falls screening will be done using Short-Falls Efficacy Scale-International (Short FES-I) to determine mild risk of falls elderly population. we will use a new 2D motion analysis system called GaitON (Auptimo Technologies LLP, India) to investigate the gait kinematic parameters during walking. Stance phase to Swing phase %, single support to double support %, joint angles (hip, knee & ankle), stride length, step length data will be collected pre- intervention. TUG & POMA test will also be performed during pre-intervention. A familiarization session will be conducted for the subjects prior to the intervention and no data will be collected in the familiarization session. Intervention group 1 will receive Timing and Coordination Training whereas; Control group 2 will not receive any intervention and will continue to do their day-to-day activities. Post-intervention data will be collected after 8 weeks. |