The Efficacy of Combined High-definition Transcranial Direct Current Stimulation (HD-tDCS) and Step Training in Older Adults With Mild Dementia: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Choice Stepping Reaction Time (CSRT) Test Completion Time
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Interested persons will be included if they are (1) aged 65 years or older; (2) able to walk 10 m without assistance; (3) can communicate in Chinese; and (4) clinically diagnosed with dementia, with mild-stage severity evidenced by a total score of 10 to 18 (inclusive) on the Hong Kong version of the Montreal Cognitive Assessment (HK-MoCA) [21].
排除标准
- •Individuals will be excluded if they, or their caregivers, report: (1) severe cardiopulmonary diseases, severe musculoskeletal disorders, or severe visual or hearing impairments; (2) any neurological conditions other than dementia; (3) contraindications to tDCS, including metallic head implants (excluding dental fillings), cardiac pacemakers, skull defects, a history of unprovoked seizures, or skin/scalp lesions at electrode sites; or (4) concurrent or recent physical therapy or non-invasive brain stimulation within the past 3 months.
研究组 & 干预措施
active HD-tDCS plus step training
干预措施: Step training (Behavioral)
active HD-tDCS plus step training
干预措施: active HD-tDCS (Device)
sham HD-tDCS plus step training
干预措施: Step training (Behavioral)
sham HD-tDCS plus step training
干预措施: sham HD-tDCS (Device)
结局指标
主要结局
Choice Stepping Reaction Time (CSRT) Test Completion Time
时间窗: Baseline, mid-point of intervention (Week 6), immediate post-intervention (Week 12), and 3-month follow-up (Week 24)
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.
次要结局
- Dorsolateral Prefrontal Cortex (DLPFC) Hemodynamic Response During Choice Stepping(Baseline, immediate post-intervention, and 3-month follow-up)
- Berg Balance Scale (BBS) Score(Baseline, immediate post-intervention, and 3-month follow-up)
- Maximum Step Length(Baseline, immediate post-intervention, and 3-month follow-up)
- Single- and Dual-Task TUG Speed(Baseline, immediate post-intervention, and 3-month follow-up)
- Trail Making Test (TMT) Score(Baseline, immediate post-intervention, and 3-month follow-up)
研究者
Marco Yiu-Chung Pang
Chair Professor
The Hong Kong Polytechnic University