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CTRI Number  CTRI/2025/11/098060 [Registered on: 25/11/2025] Trial Registered Prospectively
Last Modified On: 24/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Single Arm Study 
Public Title of Study   Training people living at home after stroke to walk while doing another task so they can improve balance and reduce falls 
Scientific Title of Study   Implementation of Dual-Task Gait Training for Fall Risk Reduction in Community-Dwelling Post-Stroke Survivors: A Feasibility Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  vijayakumar palaniswamy 
Designation  Professor 
Affiliation  Srinivas University 
Address  Institute of Physiotherapy (Department of Physiotherapy), Srinivas University, Ground Floor, City Campus, Pandeshwar, Mangaluru – 575001, Karnataka

Dakshina Kannada
KARNATAKA
575001
India 
Phone  8148745409  
Fax    
Email  vijayakumarpalaniswamy.ipt@srinivasuniversity.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Mansi Chauhan 
Designation  Post Graduate Student 
Affiliation  Institute of Physiotherapy Srinivas University 
Address  Institute of Physiotherapy (Department of Physiotherapy), Srinivas University, Ground Floor, City Campus, Pandeshwar, Mangaluru – 575001, Karnataka

Dakshina Kannada
KARNATAKA
575001
India 
Phone  98055 80883  
Fax    
Email  cmansi169@gmail.com  
 
Details of Contact Person
Public Query  
Name  vijayakumar palaniswamy 
Designation  Professor 
Affiliation  Srinivas University 
Address  Institute of Physiotherapy (Department of Physiotherapy), Srinivas University, Ground Floor, City Campus, Pandeshwar, Mangaluru – 575001, Karnataka

Dakshina Kannada
KARNATAKA
575001
India 
Phone  8148745409  
Fax    
Email  vijayakumarpalaniswamy.ipt@srinivasuniversity.edu.in  
 
Source of Monetary or Material Support  
Society of Indian Physiotherapists (SIP), c/o Amar Jyoti Institute of Physiotherapy, Karkardooma, Vikas Marg, Delhi – 110092, India 
 
Primary Sponsor  
Name  Srinivas University 
Address  Instiute of Physiotherapy, Srinivas University, City Campus, Pandeshwar, Mangalore-575001, Karnataka 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vijayakumar Palaniswamy Principal Investigator  Srinivas University, City Campus, Mangaluru  Institute of Physiotherapy (Department of Physiotherapy), Ground Floor, City Campus Building, Room No. G06, Pandeshwar, Mangaluru – 575001, Karnataka, India.
Dakshina Kannada
KARNATAKA 		 8148745409

vijayakumarpalaniswamy.ipt@srinivasuniversity.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Review Board, Srinivas University  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I699||Sequelae of unspecified cerebrovascular diseases,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dual-task gait training programme  Participants will receive an intensive, progressive dual task gait training programme supervised by a physiotherapist. Sessions will be conducted three times per week for 45 to 60 minutes over 6 to 8 weeks, giving approximately 18 to 24 sessions. Each session will start with warm up balance and gait exercises, followed by core dual task walking blocks and a brief cool down. Dual task blocks will combine overground walking on marked paths with simultaneous cognitive tasks such as serial subtraction, word generation, verbal recall and simple Stroop type tasks performed aloud. Motor tasks will include walking while carrying light household objects and negotiating simple obstacle layouts using cones, step targets and floor markings. Task difficulty will be progressed using a predefined plan by increasing walking distance, speed, path complexity and cognitive load according to individual tolerance. Training will initially be delivered with close supervision and safety measures such as gait belts and will usually be provided in small groups of about three to five participants in an outpatient or community rehabilitation setting. A simple home based dual task practice programme with illustrated handouts will support practice between sessions and promote adherence. 
Comparator Agent  Not applicable  Not applicable. This is a single arm pre post feasibility study with no comparator group.  
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Adults aged 40 years or older, at least 6 months after ischaemic or haemorrhagic stroke.
2. Living in the community (own home or with family) and attending outpatient or community rehabilitation services.
3. Able to walk a minimum distance of 10 metres independently or with a single walking aid such as a stick or quad cane, without hands-on physical assistance from another person.
4. Mini Mental State Examination score 24 or above, indicating sufficient cognition to follow instructions and participate in dual task training.
5. Medically stable and cleared for physiotherapy by the treating physician.
6. Willing to attend the training sessions and able to provide written informed consent. 
 
ExclusionCriteria 
Details  Severe visual, auditory or musculoskeletal impairments that significantly affect gait or balance.
2. Other neurological disorders that affect gait or cognition, such as Parkinson disease or multiple sclerosis.
3. Unstable cardiovascular status, uncontrolled hypertension or any acute medical illness that makes exercise training unsafe.
4. Severe lower limb spasticity (Modified Ashworth Scale score greater than three) or fixed contractures that preclude safe walking.
5. Cognitive or behavioural problems that prevent following simple instructions.
6. Any condition judged by the treating physician or physiotherapist to make participation unsafe or interfere with completion of training. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate feasibility of implementing a 6-week culturally adapted dual-task gait training protocol based on recruitment rate, retention/attrition, session attendance, home-exercise adherence, participant acceptability, and safety (adverse events, near-falls).  Baseline and post-intervention (after completion of the 6-week training program). 
 
Secondary Outcome  
Outcome  TimePoints 
Balance – Berg Balance Scale (BBS).  Baseline and post-intervention. 
Gait speed – 10-Metre Walk Test (10MWT).  Baseline and post-intervention. 
Fall self-efficacy – Falls Efficacy Scale–International (FES-I).  Baseline and post-intervention. 
Feasibility and acceptability metrics: recruitment yield, attendance, adherence to home programme, satisfaction, perceived usefulness, difficulty, willingness to continue, and participant-reported barriers/facilitators.  Monitored continuously during the 6-week study; summarised post-intervention. 
 
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   N/A 
Date of First Enrollment (India)   02/02/2026 
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="8"
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   This study aims to evaluate the feasibility, safety, and preliminary effects of a culturally adapted dual task gait training programme for community dwelling post stroke survivors in an Indian rehabilitation setting. A single group pre post feasibility design will be used. Twenty four adults who are at least six months after stroke and able to walk ten metres with or without a walking aid will receive a six week supervised dual task gait training programme delivered twice weekly in a community rehabilitation centre. Training will combine functional walking tasks with simple culturally relevant cognitive tasks. A home based component will support practice and adherence. Feasibility outcomes will include recruitment rate, retention, session attendance, home exercise adherence, acceptability, and safety. Clinical outcomes will include balance using the Berg Balance Scale, gait speed using the Ten Metre Walk Test, and fall self efficacy using the Falls Efficacy Scale International. Assessments will be conducted at baseline and after completion of the six week intervention. Findings will inform the design of a future multicentre randomised trial and support implementation of dual task gait training in Indian physiotherapy practice. 
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