Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001008314
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
3/05/2026
Date registered
Help: Date registered
17/08/2026
Date last updated
Help: Date last updated
17/08/2026
Date data sharing statement initially provided
Help: Data sharing statement date
17/08/2026
Type of registration
Help: Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy of cognitive dual task training on balance in patients with stroke
Scientific title
Efficacy of cognitive dual task training on balance in patients with stroke
Additional trial identifiers [1] 317179 0
Nil
Universal Trial Number (UTN)
Trial acronym
CDTT (Cognitive Dual-Task Training)
Related trial records

Health condition
Health condition(s) studied:
Stroke 341755 0
Condition category
Condition code
Stroke 337830 337830 0 0
Ischaemic
Stroke 337831 337831 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Participants allocated to the experimental group will receive cognitive dual-task training (CDTT) in combination with conventional balance exercises. The cognitive tasks include: addition/subtraction, forward and backward counting, category naming, word chain execution, poem recitation, backward sentence recitation, colour discrimination, backward spelling, and verbal analogical reasoning. All tasks will be performed concurrently with conventional balance exercises.

The intervention will be delivered by a qualified physiotherapist with experience in neurorehabilitation and stroke rehabilitation. Sessions will be conducted face-to-face on an individual basis under direct supervision.

The intervention will be provided 3 times per week for 4 weeks. Each session will last 30 minutes, consisting of 10 tasks performed for 3 minutes each alongside balance exercises. The intervention will be conducted in the outdoor neurology unit of the physiotherapy department of Centre for the Rehabilitation of the Paralysed (CRP), Savar, Dhaka, Bangladesh. Adherence will be monitored through supervised sessions and attendance records. Participants will receive reminders for scheduled sessions, and missed sessions will be followed up. The intervention will not be individualised. All participants allocated to the experimental group will receive the same standardized cognitive dual-task training (CDTT) protocol, combined with conventional balance exercises.
Intervention code [1] 333949 0
Treatment: Other
Description of the comparator or control
Participants allocated to the control group will receive only conventional physiotherapy. The control treatment will include sitting and standing practice, reaching tasks, ball-throwing activities, weight-shifting exercises, weight-bearing exercises, single-leg stance, squatting, balance training on a wobble board, stepping practice, walking (forward, backward, sideways), and gait training on even and uneven surfaces.

The intervention will be delivered by a qualified physiotherapist with experience in neurorehabilitation and stroke rehabilitation. Sessions will be conducted face-to-face on an individual basis under direct supervision.

The intervention will be provided 3 times per week for 4 weeks. Each session will last 45 minutes.

The intervention will be conducted in outdoor neurology unit of physiotherapy department of Centre for the Rehabilitation of the Paralysed (CRP), Savar, Dhaka, Bangladesh. Adherence will be monitored through supervised sessions and attendance records.
Control group
Active

Outcomes
Primary outcome [1] 345291 0
To evaluate the efficacy of cognitive dual-task training on balance in patients with stroke.
Timepoint [1] 345291 0
Baseline and after 4 weeks of intervention
Secondary outcome [1] 461186 0
Gait parameters will be assessed as a composite secondary outcome, comprising gait speed, cadence, step length, and stride length.
Timepoint [1] 461186 0
Baseline and after 4 weeks of intervention

Eligibility
Key inclusion criteria
1. Patients with stroke who are taking rehabilitation service at CRP
2. Age between 20 to 80 (Liu et al., 2017)
3. Both male and female (Rai and Ganvir, 2020)
4. A score of greater than 24 on the mini-mental state examination (MMSE) (Liu et al., 2017)
5. Ability to take one or more steps with or without assistance (Zheng Jiejiao et al., 2012)
6. Stable medical condition to allow participation in testing protocol and intervention (Zheng Jiejiao et al., 2012)
Minimum age
20 Years
Maximum age
80 Years
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
1. Any uncontrolled health condition for which exercise was contraindicated (Liu et al., 2017)
2. Non-stroke-related sensory or motor impairments (Zheng Jiejiao et al., 2012)
3. Aphasia (Rai and Ganvir, 2020)
4. Hearing impairment or visual impairment (Rai and Ganvir, 2020)
5. Seizures disorder (Rai and Ganvir, 2020)
6. Any other significant neurological or orthopedic disorder of gait including amputation (Rai and Ganvir, 2020)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Computer generated randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size was calculated using G*Power (version 3.1.9.4). The calculation was based on detecting a moderate effect size (0.56), derived from previous literature (Sengar et al., 2019), with a significance level (a) of 0.05 and statistical power of 95% (1–ß = 0.95). Based on these assumptions, a minimum total sample size of 36 participants was estimated. Sample size was calculated using G*Power (version 3.1.9.4). The calculation was based on detecting a moderate effect size (0.56), derived from previous literature (Sengar et al., 2019), with a significance level (a) of 0.05 and statistical power of 95% (1–ß = 0.95). Based on these assumptions, a minimum total sample size of 36 participants was estimated. To account for potential attrition, 40 participants with stroke will be recruited (20 participants each group).

Data will be analyzed using IBM SPSS Statistics 25. Descriptive statistics will summarize baseline characteristics. Normality will be assessed using the Shapiro–Wilk test. Within-group comparisons will use paired t-tests (or Wilcoxon signed-rank tests), and between-group comparisons will use independent t-tests (or Mann–Whitney U tests). A p-value <0.05 will be considered statistically significant. Effect sizes will be reported, and intention-to-treat analysis will be applied for missing data.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/06/2026
Date of last participant enrolment
Anticipated
3/09/2026
Actual
Date of last data collection
Anticipated
3/10/2026
Actual
Sample size
Target
40
Accrual to date
27
Final
Recruitment outside Australia
Country [1] 28074 0
Bangladesh
State/province [1] 28074 0
Savar, Dhaka

Funding & Sponsors
Funding source category [1] 321760 0
Self funded/Unfunded
Name [1] 321760 0
Country [1] 321760 0
Primary sponsor type
Individual
Name
Sabrina Tina – Bangladesh Health Professions Institute (BHPI), Centre for the Rehabilitation of the Paralysed (CRP), Savar, Dhaka-1343, Bangladesh
Address
Country
Bangladesh
Secondary sponsor category [1] 324601 0
Individual
Name [1] 324601 0
Saiba Muhammad Sabrin – Bangladesh Health Professions Institute (BHPI), Centre for the Rehabilitation of the Paralysed (CRP), Savar, Dhaka-1343, Bangladesh
Address [1] 324601 0
Country [1] 324601 0
Bangladesh

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 320306 0
Institutional Review Board (IRB) of BHPI
Ethics committee address [1] 320306 0
Ethics committee country [1] 320306 0
Bangladesh
Date submitted for ethics approval [1] 320306 0
03/10/2024
Approval date [1] 320306 0
15/12/2024
Ethics approval number [1] 320306 0
CRP-BHPI/IRB/12/2024/1008

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 150030 0
Dr Sabrina Tina
Address 150030 0
Centre for the Rehabilitation of the Paralysed (CRP), Savar, Dhaka-1343, Bangladesh
Country 150030 0
Bangladesh
Phone 150030 0
+8801819059951
Fax 150030 0
Email 150030 0
[email protected]
Contact person for public queries
Name 150031 0
Faruq Ahmed
Address 150031 0
Centre for the Rehabilitation of the Paralysed (CRP), Savar, Dhaka-1343, Bangladesh
Country 150031 0
Bangladesh
Phone 150031 0
+8801676761630
Fax 150031 0
Email 150031 0
[email protected]
Contact person for scientific queries
Name 150032 0
Saiba Muhammad Sabrin
Address 150032 0
Centre for the Rehabilitation of the Paralysed (CRP), Savar, Dhaka-1343, Bangladesh
Country 150032 0
Bangladesh
Phone 150032 0
+8801791767919
Fax 150032 0
Email 150032 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Ethical approval    ApprovalLetter.pdf
Study protocol    study protocol.pdf


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.