Recovering Arm Function in Chronic Post-stroke Patients Using Combined HD-tDCS and Virtual Reality Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Change in Functional Motor capacity of the upper extremity
研究概览
简要总结
The study aims to determine the added value of combining high-definition transcranial direct current stimulation (HD-tDCS) in a rehabilitation program based on virtual reality therapy (VRT) to potentiate the effects on neuroplasticity and further improve functional recovery of the arm in chronic stroke patients.
详细描述
Stroke remains the leading cause of acquired disability in France. Moreover, even after the first 3 months of intense arm rehabilitation, 80% of chronic stroke patients don't use their paretic arm in activities of daily living.
To this day, despite notable developments, techniques of rehabilitation of the arm for chronic stroke patients are still insufficient. In this context, two promising stroke rehabilitation techniques are to be considered:
- Virtual reality-based systems provide specific, intensive, repetitive and motivational therapy with real-time feedback of movement and performance which can promote activity-dependent brain neuroplasticity, and therefore functional arm recovery. Thus, virtual reality therapy (VRT), in addition to usual rehabilitation, would improve the function of the arm more effectively as well as daily activities.
- Non-invasive transcranial direct current stimulation (tDCS) uses constant low intensity (2 mA) continuous electrical currents to modulate the excitability of cortical neurons. Because of its greater focality of neuromodulatory effect that promotes brain neuroplasticity, anodal HD-tDCS to the lesioned hemisphere can improve functional arm recovery after a stroke. In addition, the combined use of the HD-tDCS with a rehabilitation modality, such as constraint induced movement therapy, would potentiate the combined effects of both techniques.
Therefore, the investigators hypothesize that the combination of HD-tDCS in a rehabilitation program based on VRT would potentiate the effects on neuroplasticity and would further improve functional recovery of the paretic arm in chronic stroke patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient aged 18 to 90
- •Patient with more than 3 months of a first cerebrovascular accident whatever the aetiology
- •Patient with paresis of the upper extremity (FM-UE ≥ 15)
排除标准
- •Failure to collect written informed consent after a period of reflection
- •Not be affiliated with a French social security scheme or beneficiary of such a scheme
- •Major deficit of the upper extremity (FM-UE <15)
- •History of epilepsy
- •Presence of a pacemaker or a metallic object implanted in the head
- •Pregnant or lactating
- •Severe neglect or attention deficit disorder (omission of more than 15 bells in the Bell's test)
- •Severe cognitive impairment (Mini Mental Score <24)
- •Aphasia with impairment of understanding (Boston Aphasia Quotient <4/5)
- •Under guardianship or curatorship
- •Protected by law
研究组 & 干预措施
HD-tDCS and Virtual Reality Therapy
Patients will receive their usual rehabilitation program each day, which includes a conventional session (30min) and virtual reality therapy session (Armeo Spring) combined with real stimulation (30min) over 13 consecutive training days (3 weeks)
干预措施: HD-tDCS (Device)
Sham stimulation and Virtual Reality Therapy
Patients will receive their usual rehabilitation program each day, which includes a conventional session (30min) and virtual reality therapy session (Armeo Spring) combined with Sham stimulation (30min) over 13 consecutive training days (3 weeks)
干预措施: Sham HD-tDCS (Device)
结局指标
主要结局
Change in Functional Motor capacity of the upper extremity
时间窗: Change from Day 21 at 3 months (retention)
Arm functional capacity assessed by the Wolf Motor Function Test (WMFT) (0-75, where higher scores mean better arm functional capacity)
Change in Hand dexterity
时间窗: Change in Day21 at 3 months (retention)
Measured by the Box and Block Test (BBT) score (greater number of blocks moved in 1minute means better hand dexterity)
Change in Motor deficit of the upper extremity
时间窗: Change from Day 21 at 3 months (retention)
Measured by the Fugl-Meyer Upper Extremity (FMUE) score (0-66, where higher scores mean a better recovery)
次要结局
- Change in Non-use of the paretic upper extremity(Change from Day 21 at 3 months (retention))
- The use of the paretic upper extremity in activities of daily living(Change from Baseline at Post (10 days after the intervention), and Post 3 months (10 days at 3 months post intervention))
- The use of each upper extremity in activities of daily living(Change from Post at Post 3 months (retention))
- Change in Activities of daily living(Change from Day 21 at 3 months (retention))