| CTRI Number |
CTRI/2025/09/095355 [Registered on: 24/09/2025] Trial Registered Prospectively |
| Last Modified On: |
24/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Testing of RetroDas Protocol for Older Adults |
|
Scientific Title of Study
|
Development, Content Validation, and Clinical Feasibility Testing of RetroDas: A Novel Rehab Protocol for 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 |
Dr Sidharth Bansal |
| Designation |
Assistant Professor |
| Affiliation |
Lovely Professional University |
| Address |
Department of physiotherapy, School of Allied Medical Science, Lovely Professional University
Kapurthala PUNJAB 144411 India |
| Phone |
8930129001 |
| Fax |
|
| Email |
sidharthphysio27@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Antar Das |
| Designation |
PG Scholar |
| Affiliation |
Lovely Professional University |
| Address |
Department of physiotherapy, School of Allied Medical Science, Lovely Professional University
Kapurthala PUNJAB 144411 India |
| Phone |
6280307381 |
| Fax |
|
| Email |
antards808@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Sidharth Bansal |
| Designation |
Assistant Professor |
| Affiliation |
Lovely Professional University |
| Address |
Department of physiotherapy, School of Allied Medical Science, Lovely Professional University
Kapurthala PUNJAB 144411 India |
| Phone |
8930129001 |
| Fax |
|
| Email |
sidharthphysio27@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy OPD block 3 room no 105, School of Allied Medical Sciences, Lovely Professional University, Phagwara, jalandhar, Punjab, 144411 |
|
|
Primary Sponsor
|
| Name |
Antar Das |
| Address |
Lovely Professional University, Jalandhar-Delhi G.T. Road, Phagwara, Punjab 144411 |
| Type of Sponsor |
Other [Self-funded] |
|
|
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 Sidharth Bansal |
Lovely Professional University |
Physiotherapy OPD Room No. 105, Department of physiotherapy, School of Allied Medical Science, Lovely Professional University Kapurthala PUNJAB |
8930129001
sidharthphysio27@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE (IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Older Adults |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
RetroDas |
Backward static cycling with ball throwing 3 sets of 3 minutes. Backward Walking with Opposite Number Counting 3 repetitions. Backward Heel and Toe Walk with Immediate Memory Recall 3 sets of 1 minute each. Backward Tandem Walk 3 sets of 1 minute each. Backward Stair Up & Down 3 sets of 7 steps each. Backward Zig-Zag Walking with eye-hand coordination 3 sets of 1 minute each. Backward Cross-Leg Walk 3 sets of 10 repetitions. Backward alternating arm and leg movement 3 sets of 20 repetitions each. Backward One-Leg Raise with interval counting 3 sets of 10 repetitions each. Backward multidirectional towel sliding 3 sets of 10 repetitions per leg. Backward Walk with Rotatory Ankle Sliding 3 sets of 1 minute each. Backward Low Squat Walk 3 sets of 10 steps each.
|
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Medically stable
2. Age 60 TO 80 years
3. Able to ambulate independently or with minimal assistive support
4. Both male and female
5. Patient must be able to follow instructions
|
|
| ExclusionCriteria |
| Details |
1. Severe cognitive impairment
2. Recent orthopedic or neurological surgeries involving the lower limb
3. Uncontrolled comorbidities
4. Severe balance impairment
5. Psychological impairment
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Timed Up and Go (TUG)
Berg Balance Scale (BBS)
|
3 time points (1st day, 14th day, and 28th day) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
10-Meter Walk Test (10MWT)
Montreal Cognitive Assessment (MoCA)
|
3 time points (1st day, 14th day, and 28th day) |
|
|
Target Sample Size
|
Total Sample Size="24" Sample Size from India="24"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
05/10/2025 |
| 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="10" 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
|
Aging is often accompanied by declines in balance, mobility, and cognitive-motor coordination, increasing the risk of falls and functional limitations in older adults. Backward movement-based exercises have shown promise in enhancing neuromuscular control and dynamic stability, but a structured and validated protocol specifically for the geriatric population remains unexplored. Aim is to develop and validate the RetroDas rehab protocol—a backward movement-based rehabilitation approach—and to assess its feasibility, safety, and preliminary effects on static and dynamic balance, walking speed, and motor-cognitive integration in older adults through a pilot study. |