| CTRI Number |
CTRI/2026/01/101681 [Registered on: 20/01/2026] Trial Registered Prospectively |
| Last Modified On: |
04/09/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Task-Based Exercise Training on Walking Ability and Quality of Life in Stroke Patients. |
|
Scientific Title of Study
|
Effectiveness of task-oriented circuit training (TOCT) for locomotor performance and quality of life among stroke survivors: A Randomized 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 |
Tuhin Ahammed |
| Designation |
Lecturer |
| Affiliation |
Bangladesh Health Professions Institute (BHPI) |
| Address |
Department of Physiotherapy, BHPI, CRP, Chapain, Savar, Dhaka
1343 Other |
| Phone |
8801741788825 |
| Fax |
|
| Email |
ahammedtuhin94@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Professor Md Obaidul Haque |
| Designation |
Vice Principal |
| Affiliation |
Bangladesh Health Professions Institute (BHPI) |
| Address |
BHPI, CRP, Chapain, Savar, Dhaka
1343 Other |
| Phone |
8801712054026 |
| Fax |
|
| Email |
obaidul.haque@crp-bangladesh.org |
|
Details of Contact Person Public Query
|
| Name |
Professor Md Obaidul Haque |
| Designation |
Vice Principal |
| Affiliation |
Bangladesh Health Professions Institute (BHPI) |
| Address |
CRP, Chapain, Savar, Dhaka
1343 Other |
| Phone |
8801712054026 |
| Fax |
|
| Email |
obaidul.haque@crp-bangladesh.org |
|
|
Source of Monetary or Material Support
|
| Self-funded by the investigator. No external monetary or material support. |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Bangladesh |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Professor Dr Mohammad Anwar Hossain Senior Consultant and Head Department of Physiotherapy CRP |
Neurology Unit, Department of Physiotherapy, CRP, Bangladesh |
Centre for the Rehabilitation of the Paralysed (CRP), Savar, Dhaka 1343, Bangladesh
|
8801730059633
anwar.hossain@crp-bangladesh.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board (IRB), BHPI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I678||Other specified cerebrovascular diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Physiotherapy |
Participants will receive conventional physiotherapy 3 times per week for 6 weeks (total 18 sessions). Each session (45–50 min) will include: positioning, reaching, bridging, leg raising, trunk rotation, core strengthening (plank), squatting, thoracic expansion, static and dynamic sitting balance (with gym ball), weight-bearing, sit-to-stand, step-ups/downs, weight shifting, and pelvic tilting exercises. Exercises will be progressed according to tolerance. |
| Intervention |
Task Oriented Circuit Training |
Participants in the experimental group will receive task-oriented circuit training in addition to conventional physiotherapy on alternate days. The TOCT program consists of 8 task-specific workstations performed sequentially.
Each workstation will be performed for 2 minutes, with a 1-minute rest period between stations. A 2-minute warm-up will be provided prior to the circuit. Total session duration will be approximately 25 minutes.
The tasks include:
1.Standing and reaching for objects
2.Sit-to-stand, walking, turning, and sitting
3.Walking and picking up objects from the floor
4.Walking with obstacles
5.Backward walking
6.Ball kicking in standing
7.Swiss ball squats
8.Tandem walking.
Task difficulty will be progressively increased by modifying distance, speed, resistance, complexity, or support as tolerated.
Frequency and Duration:
3 sessions per week for 6 weeks
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
•Hemiplegia due to stroke 6 months after onset.
•Ability to walk a minimum of 10 m without physical assistance from a therapist. (i.e., patient may require verbal supervision or stand-by help from a person, and using an aid or orthotics is allowed).
•Sufficient to follow instructions (MMSE score more than 23).
•Giving informed consent and being motivated to participate in intervention or usual care for 6 weeks.
|
|
| ExclusionCriteria |
| Details |
•Progressive neurological disease or medical condition affecting walking.
•Significant limitation of hip or knee joint range of motion.
•Pregnancy (excluded for safety and ethical reasons related to balance and exercise tolerance).
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in locomotor performance as measured by the Timed Up and Go Test (TUG), 10-Meter Walk Test (10MWT), 2 Minute Walk Test (2MWT) and Functional Ambulatory Classification (FAC). |
Baseline, 2 weeks, 4 weeks, and 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in quality of life as measured by the Stroke-Specific Quality of Life Scale–17 (SSQOL-17) |
Baseline, 2 weeks, 4 weeks, and 6 weeks. |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="0"
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)
|
14/02/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
14/02/2026 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0" Months="3" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Not Applicable |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [obaidul.haque@crp-bangladesh.org].
- For how long will this data be available start date provided 15-07-2026 and end date provided 13-07-2031?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
Brief Summary
Modification(s)
|
This randomized controlled trial will evaluate the effectiveness of task-oriented circuit training (TOCT) combined with conventional physiotherapy on locomotor performance and quality of life in stroke survivors. Participants will be allocated to either TOCT plus conventional physiotherapy or conventional physiotherapy alone. The intervention will be provided 3 times per week for 6 weeks. Outcomes will be assessed at baseline, 2 weeks, 4 weeks, and 6 weeks using TUG,10MWT, 2MWT, and FAC as primary outcomes and SSQOL-17 as a secondary outcome. |