| CTRI Number |
CTRI/2025/11/098108 [Registered on: 26/11/2025] Trial Registered Prospectively |
| Last Modified On: |
20/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Recovering from Stroke at Home: Can Virtual Dual-Task Training Improve Balance, Mobility, and Brain Power |
|
Scientific Title of Study
|
Feasibility of tele rehabilitation approach in dual task training on balance, mobility and cognitive function in patients with sub acute stroke |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Amal k Saji |
| Designation |
Postgraduate student |
| Affiliation |
Yenepoya physiotherapy college |
| Address |
Yenepoya Physiotherapy College, Ayush campus, 6th floor,Naringana, Deralakatte Mangalore - 575018. Karnataka State, India
Dakshina Kannada KARNATAKA 575018 India |
| Phone |
7356465317 |
| Fax |
|
| Email |
34320@yenepoya.edu.in |
|
Details of Contact Person Scientific Query
|
| Name |
Prof Dr.Smitha D |
| Designation |
Additional professor |
| Affiliation |
Yenepoya physiotherapy college |
| Address |
Yenepoya Physiotherapy College. Ayush campus,6th floor, Naringana, Deralakatte, Mangalore - 575018. Karnataka State, India
Dakshina Kannada KARNATAKA 575018 India |
| Phone |
9886318394 |
| Fax |
|
| Email |
smithad@yenepoya.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Prof Dr.Smitha D |
| Designation |
Additional professor |
| Affiliation |
Yenepoya physiotherapy college |
| Address |
Yenepoya Physiotherapy College, Ayush campus, 6th floor,Naringana, Deralakatte Mangalore - 575018, Karnataka State, India
Dakshina Kannada KARNATAKA 575018 India |
| Phone |
9886318394 |
| Fax |
|
| Email |
smithad@yenepoya.edu.in |
|
|
Source of Monetary or Material Support
|
| Yenepoya Physiotherapy College, Ayush campus, 6th floor,Naringana, Deralakatte Mangalore - 575018. Karnataka State, India |
|
|
Primary Sponsor
|
| Name |
Dr Amal K Saji PT |
| Address |
Yenepoya Physiotherapy College, Ayush campus,6th floor, Naringana, Deralakatte Mangalore - 575018. Karnataka State, India E |
| 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 |
| DrAmal K Saji PT |
Yenepoya Ayurveda medical college hospital |
Yenepoya Physiotherapy College, Ayush campus,6th floor,Naringana, Deralakatte Mangalore - 575018, Karnataka State, India Dakshina Kannada KARNATAKA |
7356465317
34320@yenepoya.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| yenepoya Ethics committee 3 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I679||Cerebrovascular disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dual task training |
Dual-task training helps subacute stroke patients by targeting both motor and cognitive recovery simultaneously, which reflects real-life challenges where multitasking is common. In my study, the intervention is delivered over a period of 6 weeks, with one supervised telerehabilitation session per week, ensuring consistent, structured, and progressive dual-task practice, with each session lasting 45 minutes, comprising a 5-minute warm-up, 15 minutes of conventional therapy, 20 minutes of dual-task training, and a 5-minute cool-down.
The total duration of the intervention is 6 weeks (6 supervised telerehabilitation sessions).” |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
• Participants diagnosed clinically at first onset of unilateral stroke with duration of 3 to 9 months.
• Participants with Brunnstorm stage of 2 and
above.
• MoCA score between 18 to 25 (indicating mild cognitive impairment)
• Participants of 18 to 60 years of age.
• Participants who can walk with or without the
use of assistive devices at least 10m distance.
• Participants with normal or corrected vision and
hearing are included
|
|
| ExclusionCriteria |
| Details |
• Participants with any musculoskeletal disorders
such as recent fractures or dislocations,
congenital or acquired disorders or deformities,
acute or chronic arthritis.
• Participants with any Cardio-vascular disorders
such as Triple vessel disease, angina pectoris,
congenital or acquired heart diseases.
• Other neurological problems such as pre-existing
neurological disorders and progressive diseases
(like Dementia, Alzheimer’s disease,
Parkinsonism, Brain tumours, Cerebral palsy)
• participants with any visual or auditory
problems (Blindness, colour vision, diplopia,
total or partial blindness).
• Participants with active cancer
• Participants with multiple stroke
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) The Berg Balance Scale
(BBS)
2) Montreal cognitive
assessment (MOCA)
3) The Timed UP and Go test
(TUG)
|
Baseline (Week 0) – BBS, TUG,
MOCA
Post-intervention (Week 6) – BBS, TUG, MoCA
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="32" Sample Size from India="32"
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)
|
01/12/2025 |
| 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="1" Months="0" 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
|
Stroke patients frequently experience gait abnormalities and cognitive deterioration, which have a major negative influence on their day to day life and quality of life. Sub acute stroke patients, in particular, require targeted interventions to optimize their recovery. Traditional rehabilitation approaches often focus on single-task training, which may not adequately prepare patients for the complexities of everyday life. Dual-task training (DTT), which involves performing two tasks simultaneously, has shown promise in improving gait and cognitive function in individuals with stroke. However, the effectiveness of DTT in sub acute stroke patients, particularly when delivered via tele rehabilitation, remains largely unexplored. Through tele rehabilitation approach focus is mainly patient centered, in which Patients in remote areas can receive rehabilitation services without the need to travel long distances. It reduces the need for frequent hospital visits, saving on transportation and accommodation costs. It allows for tailored rehabilitation programs that can be adjusted based on patient progress and needs. The COVID-19 pandemic has accelerated the need for remote rehabilitation solutions, making tele rehabilitation an attractive option for stroke rehabilitation. Thus study aims to investigate the effects of dual-task training on balance, gait and cognitive function in patients with sub acute stroke, using a tele rehabilitation approach. By exploring the feasibility and effectiveness of this intervention, this study will contribute to the development of innovative, accessible, and evidence-based rehabilitation strategies for sub acute stroke patient. |