Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000396426
Ethics application status
Approved
Date submitted
9/04/2025
Date registered
2/05/2025
Date last updated
2/05/2025
Date data sharing statement initially provided
2/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
SmartSTEP Stroke: Investigating the effect of a cognitive-motor step exergame program on balance and mobility in stroke survivors
Scientific title
SmartSTEP Stroke: Investigating the effect of a cognitive-motor step exergame program on balance and mobility in stroke survivors
Secondary ID [1] 314111 0
Nil known
Universal Trial Number (UTN)
Trial acronym
SmartSTEP Stroke
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic stroke 336913 0
Condition category
Condition code
Stroke 333377 333377 0 0
Haemorrhagic
Stroke 333378 333378 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Four-month cognitive-motor rehabilitation program involving step exergame training delivered through a home-based system (SmartSTEP). All intervention participants will receive the step exergame system (personal computer, software and instruction / safety booklet) and wireless step mat to interface with their television screen or provided computer monitor.

The intervention involves unsupervised cognitive-motor training using the step exergame system. The intervention incorporates both stepping/balance exercises and cognitive training. The exergames require participants to make appropriately timed and accurate steps from both legs on the step mat. The program of games is designed to train balance and fast stepping responses in addition to cognitive function (selective attention, response inhibition, working memory, visuo-spatial processing and task switching).

Trained research assistants with experience working with balance-impaired clinical groups and trained in exercise physiology, physiotherapy, nursing, neurosciences or biomedical sciences will set up the equipment in participants' homes during a 40-60 min initial home visit. They will then instruct participants on how to safely use the system.
Intervention participants will receive a follow-up phone call (or email if no reply) two weeks after installation of their systems and again at eight weeks to ensure safe use and progression of training and to discuss any issues relating to system use. Additional phone calls (or home visits) during the intervention will be offered as needed. At all points of contact with the study team, participants will be asked if they face any difficulties using the program and appropriate measures will be taken to resolve any issues.

Participants will be encouraged to undertake three to four 20–30-minute training sessions per week progressing to a target range of 80 to 120 minutes per week. We will initially encourage participants to undertake several short training sessions (e.g. 10 to 15min training sessions) per week to maximise confidence and long-term adherence. We will ask them to progress their training sessions duration (by 10% to 20% per week, considering both physical function and personal preferences / other commitments).

Participants’ intervention usage data (minutes of game play each week) will be recorded on the system computer and later transferred onto an online server at Neuroscience Research Australia.
Intervention code [1] 330686 0
Rehabilitation
Intervention code [2] 330687 0
Treatment: Devices
Comparator / control treatment
The no-training waitlist control group will receive usual care and encouraged to maintain their usual physical activities. In this study, usual care is defined as care usually received by patients in daily practice. They will be offered the four-month cognitive-motor exergame intervention following study completion (post 4-month re-assessment).
Control group
Active

Outcomes
Primary outcome [1] 340947 0
Choice Stepping Reaction Time (ms)
Timepoint [1] 340947 0
Baseline, 4-month post-baseline
Secondary outcome [1] 445563 0
Congruent Stroop Stepping Test total reaction time (ms)
Timepoint [1] 445563 0
Baseline, 4-month post-baseline
Secondary outcome [2] 445564 0
Incongruent Stroop Stepping Test total reaction time (ms)
Timepoint [2] 445564 0
Baseline, 4-month post-baseline
Secondary outcome [3] 445565 0
Functional mobility - Timed Up and Go test time (s)
Timepoint [3] 445565 0
Baseline, 4-month post-baseline
Secondary outcome [4] 445566 0
Coordinated Stability Test (error score)
Timepoint [4] 445566 0
Baseline, 4-month post-baseline
Secondary outcome [5] 445567 0
Gait Adaptability Test (stepping error rate)
Timepoint [5] 445567 0
Baseline, 4-month post-baseline
Secondary outcome [6] 445568 0
Stroke Specific Quality of Life Scale (score)
Timepoint [6] 445568 0
Baseline, 4-month post-baseline
Secondary outcome [7] 445569 0
Falls
Timepoint [7] 445569 0
Each week throughout the 4-month trial
Secondary outcome [8] 445570 0
Falls-Efficacy Scale-International (FES-I) scores
Timepoint [8] 445570 0
Baseline, 4-month post-baseline
Secondary outcome [9] 445571 0
Daily physical activity for a week
Timepoint [9] 445571 0
In the 7-days preceding baseline assessment
Secondary outcome [10] 445572 0
Trail Making Test part B – part A (s)
Timepoint [10] 445572 0
Baseline, 4-month post-baseline
Secondary outcome [11] 445573 0
Serious adverse events (e.g. a fall while doing the step training)
Timepoint [11] 445573 0
Weekly from randomisation until 4 months post-baseline
Secondary outcome [12] 445574 0
Adherence
Timepoint [12] 445574 0
Weekly from randomisation until 4 months post-baseline
Secondary outcome [13] 445575 0
Recruitment rate
Timepoint [13] 445575 0
Cumulative data will be assessed at the conclusion of the recruitment period.
Secondary outcome [14] 445576 0
Consent rate
Timepoint [14] 445576 0
Cumulative data will be assessed at the conclusion of the recruitment period.
Secondary outcome [15] 445577 0
Retention rate
Timepoint [15] 445577 0
Weekly from randomisation until 4 months post-baseline

Eligibility
Key inclusion criteria
• 18 years or older;
• at least 6 months post stroke (ischemic or haemorrhagic);
• living in the community;
• experiencing balance or mobility impairment;
• no cognitive impairment as indicated by a Short Portable Mental Status Questionnaire (SPMSQ) greater than or equal to 8
• able to communicate in English or receive support by a carer who can;
• able to provide informed consent;
• willing and able to follow all the study rules, including the training, the timing and nature of required tests.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• unable to walk 20 metres without walking aid;
• unable to independently undertake the choice stepping reaction time test;
• severe visual impairment that prevents ability to undertake stepping and walking tests;
• neurological conditions in addition to stroke, or any medical condition that prevents safe exercise participation;

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)
Following completion of baseline assessment, participants will be randomised using a web-based central randomisation service: the group allocation will be concealed .
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation. Blocks of 2, 4 and 6 will be applied to form two groups of similar size (1:1 allocation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
An intention-to-treat approach will be employed to analyse the efficacy of the intervention. Generalised linear models will be used to assess the effect of group allocation on the primary outcome measure (Choice Stepping Reaction Time test) and on the continuously scored secondary outcome measures (quality of life, balance and mobility, executive function, fear of falling, physical activity) controlling for baseline performance. The probability threshold will be set at p<0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
7/05/2025
Actual
Date of last participant enrolment
Anticipated
30/04/2027
Actual
Date of last data collection
Anticipated
31/08/2027
Actual
Sample size
Target
86
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 318619 0
Charities/Societies/Foundations
Name [1] 318619 0
Stroke Foundation Grant 2025
Country [1] 318619 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Jasmine Menant - Neuroscience Research Australia (NeuRA)
Address
Country
Australia
Secondary sponsor category [1] 321024 0
Individual
Name [1] 321024 0
Associate Professor Daina Sturnieks - Neuroscience Research Australia (NeuRA)
Address [1] 321024 0
Country [1] 321024 0
Australia
Secondary sponsor category [2] 321028 0
Individual
Name [2] 321028 0
Professor Stephen R Lord - Neuroscience Research Australia (NeuRA)
Address [2] 321028 0
Country [2] 321028 0
Australia
Secondary sponsor category [3] 321029 0
Individual
Name [3] 321029 0
Ms Kulvara Lapanan - Neuroscience Research Australia (NeuRA)
Address [3] 321029 0
Country [3] 321029 0
Australia
Secondary sponsor category [4] 321030 0
Individual
Name [4] 321030 0
Dr Lloyd Chan - Neuroscience Research Australia (NeuRA)
Address [4] 321030 0
Country [4] 321030 0
Australia
Secondary sponsor category [5] 321031 0
Individual
Name [5] 321031 0
Professor Ken Butcher - Prince of Wales Clinical School at the University of New South Wales
Address [5] 321031 0
Country [5] 321031 0
Australia
Secondary sponsor category [6] 321032 0
Individual
Name [6] 321032 0
Ms Carly Chaplin - Neuroscience Research Australia (NeuRA)
Address [6] 321032 0
Country [6] 321032 0
Australia
Secondary sponsor category [7] 321033 0
Individual
Name [7] 321033 0
Mr Logan Lock - Neuroscience Research Australia (NeuRA)
Address [7] 321033 0
Country [7] 321033 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317222 0
The University of New South Wales Research Ethics Committee
Ethics committee address [1] 317222 0
Ethics committee country [1] 317222 0
Australia
Date submitted for ethics approval [1] 317222 0
20/11/2024
Approval date [1] 317222 0
23/01/2025
Ethics approval number [1] 317222 0
2025/ iRECS7307

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

Contacts
Principal investigator
Name 140394 0
A/Prof Jasmine Menant
Address 140394 0
Neuroscience Research Australia (NeuRA), 139 Barker St, Randwick NSW 2031
Country 140394 0
Australia
Phone 140394 0
+61 2 9399 1267
Fax 140394 0
Email 140394 0
[email protected]
Contact person for public queries
Name 140395 0
Associate Professor Jasmine Menant
Address 140395 0
Neuroscience Research Australia (NeuRA), 139 Barker St, Randwick NSW 2031
Country 140395 0
Australia
Phone 140395 0
+61 2 9399 1267
Fax 140395 0
Email 140395 0
[email protected]
Contact person for scientific queries
Name 140396 0
Associate Professor Jasmine Menant
Address 140396 0
Neuroscience Research Australia (NeuRA), 139 Barker St, Randwick NSW 2031
Country 140396 0
Australia
Phone 140396 0
+61 2 9399 1267
Fax 140396 0
Email 140396 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: No/undecided IPD sharing reason/comment
Approval will be sought from the ethics committee before it can be confirmed that IPD will be available.




What supporting documents are/will be available?

No Supporting Document Provided



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.