Neuromodulation-Enhanced Use of RObotic BALANCE Training to Improve Balance Function in Individuals With Stroke
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Berg Balance Scale (BBS)
研究概览
简要总结
Our proposed study, "NEUROBALANCE Stroke,"; aims to evaluate the effectiveness of a combined intervention involving robotic balance training and noninvasive brain stimulation in improving balance function and postural control in individuals with chronic stroke. The study will recruit 45 participants who have had a stroke at least 6 months before enrolment and experience persistent balance and gait deficits. Participants will be randomized into three groups: (1) robotic balance training with active brain stimulation, (2) robotic balance training with sham brain stimulation, and (3) standard-of-care rehabilitation.
The study will involve 15 training sessions over 5 weeks, with assessments conducted at baseline, post-training, and two months post-training to evaluate balance recovery and retention. The primary focus is understanding how this intervention affects brain and muscle activity during balance tasks and how these changes translate into functional improvements in clinical outcome measures of balance function. Additionally, participant feedback on brain stimulation and exercise engagement will be collected to inform future studies.
The findings may guide the development of personalized training protocols and contribute to broader rehabilitation strategies.
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, Investigator, Outcomes Assessor)
盲法说明
The mode of HD-tDCS (active/sham) will be masked for the participant, the study investigator, and the outcomes assessor.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 18-75 years
- •Diagnosed with a cortical/subcortical ischemic stroke at least 6 months before the screening, as confirmed by the neurological exam or an MRI.
- •Have complaints of impaired balance and poor postural control determined by a BBS score of ≤
- •Ability to stand upright with or without support for at least 20 seconds
- •Ability to walk with or without a walking aid for at least ten meters
- •Not planning to change medication in the next four months
- •Minimum Cognitive Ability to understand the verbal instructions and comply with the study procedures, as determined by the University of California, San Diego, Brief Assessment of Capacity to Consent Instrument (UBACC).
排除标准
- •Currently undergoing any regular physical therapy program or research studies focusing on balance functions.
- •Having a brainstem stroke.
- •Contraindication for MRI scan (presence of metal implants, claustrophobia)
- •Affected by the peripheral nerve injury, neuromuscular conditions, or orthopedic issues of lower limbs before stroke, or have any persistent pain or difficulty maintaining blood pressure while upright.
- •Have a scalp or skin condition (e.g., psoriasis or eczema) * on the scalp near the stimulation site
- •Having severe visual impairment (e.g., spatial neglect) or hearing problems that may affect study compliance
- •Any other neurological injury or psychiatric conditions (e.g., severe anxiety or schizophrenia etc.)
- •Contraindications to MRI, including the presence of non-titanium metallic implants, claustrophobia, etc.
- •Not be pregnant or thinking of becoming pregnant
- •Diagnosed with alcohol or substance abuse in the last 3 years
- •Contraindications to TMS, including the presence of metallic implants in the head and a history of seizures or medication-resistant epilepsy or ongoing use of anti-seizure/seizure threshold-lowering medications.
研究组 & 干预措施
RBT + Active HD-tDCS Group
Participants will engage in balance and postural control training on a robotic balance platform called Hunova (Movendo, Italy). Before balance training, the current intensity of 2 mA will be delivered to the leg motor area identified using individual MRI-guided neuronavigated transcranial magnetic stimulation (nTMS), and the stimulation will be turned ON for 20 minutes.
干预措施: Combined (Robotic balance training and high-definition transcranial direct current stimulation) (Device)
RBT + Sham HD-tDCS Group
Participants will engage in balance and postural control training on a robotic balance platform called Hunova (Movendo, Italy). Before balance training, the current intensity of 2 mA will be delivered to the leg motor area identified using individual MRI-guided neuronavigated transcranial magnetic stimulation (nTMS), and the stimulation will be turned ON transiently for 30 s to provide a sensation of stimulation.
干预措施: Combined (Robotic balance training and high-definition transcranial direct current stimulation) (Device)
SOC Control Group
The standard of care (SOC) control group participants will perform dose-matched conventional physical therapy exercises delivered by a trained PT.
干预措施: Standard of Care Balance Training (Other)
结局指标
主要结局
Berg Balance Scale (BBS)
时间窗: Baseline, post 5-week training, 2-month follow-up
A widely used outcome measure of static standing balance function (Newstead et al., 2005), categorized under the 'Activity' subsection of ICF domain. BBS scores range from 0 to 56 (the higher, the better). The change in BBS scores from baseline to 4 weeks post-training will be the primary endpoint.
次要结局
- Functional Gait Assessment (FGA)(Baseline, post 5-week training, and 2-month follow-up)
- EMG Muscle Coactivation(Baseline, post 5-week training, and 2-month follow-up.)
- Mini Balance Evaluation Systems Test (MBT)(Baseline, post 5-week training, and 2-month follow-up)
- Center of Pressure (COP) Displacement(Baseline, post 5-week training, and 2-month follow-up)
- Trunk Impairment Scale (TIS)(Baseline, post 5-week training, and 2-month follow-up)
- EEG Corticocortical Functional Connectivity(Baseline, post 5-week training, and 2-month follow-up)
- EEG-to-EMG Corticomuscular Connectivity(Baseline, post 5-week training, and 2-month follow-up.)
- Diffusion Tensor Imaging (DTI) Fractional Anisotropy(Baseline and post-5-week training)
- TMS-evoked EEG Potentials (TEP)(Baseline, post 5-week training, and 2-month follow-up)
研究者
Vikram Shenoy Handiru
Research Scientist
Kessler Foundation