An interventional study of Step training and sham HD-tDCS in Dementia, tDCS and Physical Exercise, sponsored by The Hong Kong Polytechnic University. Not yet recruiting at 1 site in Hong Kong. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by The Hong Kong Polytechnic University · Not applicable, Interventional, and Treatment
Among 32 studies in Dementia by The Hong Kong Polytechnic University — 13 open to participants now, 13 under way, none of them phase 3. Dementia · The Hong Kong Polytechnic University.
Among the 32 studies in Dementia by The Hong Kong Polytechnic University, this one is the 18th largest by planned enrollment, is one of 3 that started in 2026, is one of 31 with no phase, reaches primary completion later than 11 of the 12 other live ones, and was the 32nd registered.
2,372 studies on the registry are indexed under Dementia; 574 are open to participants now.
This study's planned enrollment of 68 is below the median of 90 across 1,758 interventional studies indexed under Dementia.
Browse Dementia studies →13 of the 32 studies in Dementia by The Hong Kong Polytechnic University are open now, in 1 country. Each count lists the studies.
Of the 381 Dementia studies recruiting now, 242 (64%) set no upper age limit and 25 (7%) stop at 75 or younger; 16 take children under 18; 163 take healthy volunteers.
This study: 65 Years and older · all sexes · no healthy volunteers.
The full table on the hub →32 studies; the count open now beside each. This study's row is marked.
First in 2012; this study’s year is marked. 3 started in 2026.
Median enrollment 80 across the 32 interventional studies. Of the 13 that completed or were terminated, 1 (8%) have results posted.
The Hong Kong Polytechnic University is the lead sponsor of 679 studies on the registry; 257 are open to participants now.
3 of the studies in Dementia by The Hong Kong Polytechnic University that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07019441The Hong Kong Polytechnic UniversityA Daily-Activity-Focused, Strategy-Based Educational Programme for Informal Dementia Carers | 2026-12 |
| NCT07784946The Hong Kong Polytechnic UniversityA Behavioural Sleep Intervention for People With Mild Cognitive Impairment and Mild Dementia | 2027-07 |
| NCT06665243The Hong Kong Polytechnic UniversityHorticultural Activities Among the People with Dementia and Their Family Caregivers | 2027-11-01 |
Among the 32 studies in Dementia by The Hong Kong Polytechnic University, from their registry updates:
Falls and mobility decline are major health concerns among older adults with dementia, often linked to deterioration in executive function and cognitive-motor control. Step training interventions that challenge both cognitive and motor faculties have shown promise in enhancing balance and motor reaction to reduce fall risk. However, long-term retention of training gains remains limited, largely constrained by reduced neuroplasticity and underlying neurodegeneration in this population.
The primary objective of this study is to investigate the efficacy of high-definition transcranial direct current stimulation (HD-tDCS), a form of wearable non-invasive brain stimulation, combined with step training in community-dwelling older adults with mild dementia. Participants will be randomly allocated to either an active HD-tDCS plus step training group or a sham stimulation plus step training control group. Assessments will be conducted at baseline, immediately post-intervention, and at a 3-month follow-up to evaluate changes in cognitive and physical function (including choice stepping reaction time (CSRT), executive function, and dual-task ability) as well as cortical activity during stepping. In addition, a mid-point assessment will be conducted for the primary outcome (i.e., CSRT).
An embedded qualitative evaluation will be conducted with participant-caregiver dyads and healthcare professionals/staff to evaluate implementation outcomes and feasibility (including perceived acceptability, user experience, and practical facilitators and barriers to adoption). Findings from this trial will help optimize neuromodulation-augmented rehabilitation strategies and inform community-based fall prevention programs.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Behavioral: Step training · Device: active HD-tDCS
Behavioral: Step training · Device: sham HD-tDCS
A structured stepping exercise program will be delivered on a designated stepping mat. The intervention incorporates progressive cognitive tasks (including mental arithmetic, working memory, and executive function challenges) combined with directional volitional stepping. Training difficulty is progressively adapted based on individual performance, with physical and cognitive exertion monitored to maintain a moderate intensity level.
The sham HD-tDCS targets the prefrontal cortex via a 4×1 multi-electrode montage during training. The sham HD-tDCS delivers brief current stimulation to simulate scalp sensations without inducing neuroplastic effects to maintain blinding. All sessions are delivered by trained research personnel following standardized safety guidelines.
The active HD-tDCS targets the prefrontal cortex via a 4×1 multi-electrode montage during training. The active HD-tDCS delivers 2 mA current for 20 minutes with ramp-up and ramp-down phases. All sessions are delivered by trained research personnel following standardized safety guidelines.
Choice Stepping Reaction Time (CSRT) Test Completion Time
The clinical Choice Stepping Reaction Time (CSRT) test evaluates goal-directed volitional stepping speed and accuracy. Participants stand on a designated mat and step onto indicated target panels as quickly and accurately as possible in response to standardized verbal cues across 12 test trials. Performance is recorded as the total time (in seconds) required to successfully complete all 12 correct steps using a stopwatch. Shorter completion times indicate faster reaction and better stepping performance.
Time frame: Baseline, mid-point of intervention (Week 6), immediate post-intervention (Week 12), and 3-month follow-up (Week 24)
Dorsolateral Prefrontal Cortex (DLPFC) Hemodynamic Response During Choice Stepping
Cortical activity in the bilateral dorsolateral prefrontal cortex (DLPFC) is assessed during the choice stepping task using functional near-infrared spectroscopy (fNIRS). Performance is quantified by task-evoked changes in oxygenated hemoglobin concentration (ΔHbO) relative to baseline. Greater increases in ΔHbO reflect higher cortical activation and neural recruitment during task execution.
Time frame: Baseline, immediate post-intervention, and 3-month follow-up
Berg Balance Scale (BBS) Score
Balance will be measured using the Berg Balance Scale (BBS). Participants' ability to maintain an upright posture during 14 functional activities (e.g., sitting, rising from a seated position, transfer between two chairs, reaching while standing) will be rated on a scale ranging from 0 to 4, with higher scores reflecting greater balance.
Time frame: Baseline, immediate post-intervention, and 3-month follow-up
Maximum Step Length
The Maximum Step Length test (MSLT) assesses an individual's ability to step as far as possible in a given direction (forward, backward, or sideways) and then return to the starting position without losing balance. An average of three attempts for each direction will be recorded.
Time frame: Baseline, immediate post-intervention, and 3-month follow-up
Single- and Dual-Task TUG Speed
Cognitive-motor dual-tasking ability will be assessed using the single-task and dual-task of the Timed Up and Go (TUG) test. This dual-task TUG combines the standard mobility assessment with a simultaneous verbal fluency task. Under the instruction of a trained assessor, participants will be asked to rise from a standard chair, walk 3 meters, turn around, return to the chair, and sit down as quickly and safely as possible, while simultaneously naming items randomly chosen from a pool of topics (e.g., animals, fruits, or modes of transportation). The total time to complete the task will be recorded. Verbal responses will be monitored to ensure task engagement.
Time frame: Baseline, immediate post-intervention, and 3-month follow-up
Trail Making Test (TMT) Score
Executive function including attention shift and processing speed will be measured using the Trail Making Test (TMT), an education-fair alternative to the traditional Trail Making Test validated in older adults. The TMT consists of two parts: TMT-A (evaluates visuospatial scanning and perceptual tracking) and TMT-B (evaluates executive divided attention and mental set-shifting). TMT-A requires participants to connect numbers in an ascending sequence (i.e., numbers 1-25) enclosed in uniform circles. TMT-B requires participants to connect numbers in an ascending sequence while alternating between two distinct geometric shapes (circles and squares, e.g., 1-circle to 2-square to 3-circle). Shorter completion times indicated better performance.
Time frame: Baseline, immediate post-intervention, and 3-month follow-up
The Iconographic Falls Efficacy Scale (Icon-FES) Score
The Iconographic Falls Efficacy Scale (Icon-FES) will be used to assess participants' fear of falling during daily activities. The Icon-FES includes 10 items, each illustrated with a pictogram to facilitate comprehension, especially for individuals with cognitive impairment.
Time frame: Baseline, immediate post-intervention, and 3-month follow-up
Geriatric Depression Scale (GDS) Score
Depressive symptoms are assessed using the Geriatric Depression Scale (GDS-15). The scale consists of 15 dichotomous (yes/no) questions evaluating affective status over the past week. Total scores range from 0 to 15, with higher scores indicating more severe depressive symptoms.
Time frame: Baseline, immediate post-intervention, and 3-month follow-up
Participant and Caregiver Blinding Integrity Assessment
The success of participant and caregiver blinding is evaluated at the end of the intervention period using a standardized end-of-study guess questionnaire. Participants and their caregivers independently indicate whether they believe the received stimulation was "active", "sham", or if they are "unsure".
Time frame: Immediately post-intervention
Perceived Acceptability, Feasibility, and Implementation Determinants Assessed via Qualitative Interviews
Qualitative semi-structured interviews are conducted with participant-caregiver dyads and healthcare professionals/staff to explore intervention feasibility, perceived acceptability, user experiences, and contextual barriers and facilitators to implementation. Audio-recorded transcripts are analyzed to identify key determinants of intervention adoption and translation into community settings.
Time frame: Immediately post-intervention (Week 12)
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Mar 2028, 17 months later.
Of 855 non-industry interventional studies with no phase under Dementia, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 44. This study's planned 17 months is below that.
Counting every sponsor, half of 901 studies reached it within 25 months; a quarter within 11 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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The Hong Kong Polytechnic University →