Cortical Priming to Optimize Gait Rehabilitation: Renewal
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Walking speed with 10 meter walk test
研究概览
简要总结
Achieving functional ambulation post stroke continues to be a challenge for stroke survivors, clinicians, and researchers. In the effort to enhance outcomes of motor training, cortical priming using brain stimulation has emerged as a promising adjuvant to conventional rehabilitation. This project focuses on the development of a long term gait rehabilitation protocol using brain stimulation to improve walking outcomes in people with stroke. The project will also aim to understand the neural mechanisms that are associated with response to the intervention.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than 18 years
- •First ever monohemispheric stroke > 3 months since onset
- •Residual hemiparetic gait deficits (e.g. abnormal gait pattern)
- •Able to walk for 5 minutes at self-paced speed. Handheld assistive device is acceptable.
- •Walking speed lesser than 1.2 m/s
- •Lower limb Fugl-Meyer Motor score between 15-30
- •At least 5 deg of ankle dorsiflexion necessary to perform the ankle-tracking task
排除标准
- •General exclusion criteria
- •Severe osteoporosis
- •Contracture-limiting range of motion of lower limb
- •Score of more than 2 on the Modified Ashworth Scale (indicating increased muscle tone through ankle range of motion)
- •Uncontrolled anti-spasticity medications during the study period
- •Score less than 6 on the Fugl-Meyer Sensory Assessment Scale for the Lower Limb
- •Cardiorespiratory or metabolic diseases (e.g. cardiac arrhythmia, uncontrolled hypertension or diabetes, chronic emphysema)
- •Unhealed decubiti, persistent infection
- •Significant cognitive or communication impairment (Mini-Mental State Examination (MMSE)<21), which could impede the understanding of the purpose of procedures of the study or prevent the patient from performing the ankle-tracking task.
- •Lesions involving the brainstem and cerebellum
- •Failure to pass the graded exercise stress test
- •TMS exclusion criteria
- •Implanted cardiac pacemaker
- •Metal implants in the head or face
- •Unexplained, recurring headaches
- •History of seizures or epilepsy
- •Currently under medication that could increase motor excitability and lower seizure threshold
- •Skull abnormalities or fractures
- •Concussion within the last 6 months
- •Currently pregnant
- •tDCS exclusion criteria
- •Skin hypersensitivity
- •History of contact dermatitits
- •History of allodynia and/or hyperalgesia
- •Any other skin or scalp condition that could be aggravated by tDCS
研究组 & 干预措施
Priming+HIISTT
Facilitatory transcranial direct current stimulation (tDCS) and ankle motor training before high intensity interval speed based treadmill training
干预措施: Transcranial direct current stimulation (tDCS) (Other)
Priming+HIISTT
Facilitatory transcranial direct current stimulation (tDCS) and ankle motor training before high intensity interval speed based treadmill training
干预措施: Ankle motor training (Other)
Priming+HIISTT
Facilitatory transcranial direct current stimulation (tDCS) and ankle motor training before high intensity interval speed based treadmill training
干预措施: High intensity interval speed based treadmill training (HIISTT) (Behavioral)
Sham+HIISTT
Sham tDCS before high intensity interval speed based treadmill training
干预措施: High intensity interval speed based treadmill training (HIISTT) (Behavioral)
结局指标
主要结局
Walking speed with 10 meter walk test
时间窗: Change from baseline to immediately after training and baseline to 3 months follow up
Self-selected and fastest gait speed will be measured as the average of 3 trials of the 10-m walk test (10MWT).
次要结局
- Walking endurance with 6-minute walk test(Change from baseline to immediately after training and baseline to 3 months follow up)
- Balance with mini Balance Evaluations Systems Test (miniBESTest)(Change from baseline to immediately after training and baseline to 3 months follow up.)
- Community ambulation with wearable sensors(Change from baseline to immediately after training.)
- Walking spatiotemporal characteristics with GAITRite walkway(Change from baseline to immediately after training and baseline to 3 months follow up)
- Motor impairment with Fugl Meyer Lower Extremity Scale(Change from baseline to immediately after training and baseline to 3 months follow up)
- Ankle range of motion(Change from baseline to immediately after training and baseline to 3 months follow up)
- Ankle motor control(Change from baseline to immediately after training and baseline to 3 months follow up)
- Aerobic capacity(Change from baseline to immediately after training.)
- Quality of Life with EuroQol-5D (EQ-5D)(Change from baseline to immediately after training.)
- Depression using Patient Health Questionnaire-9 (PHQ-9)(Change from baseline to immediately after training and baseline to 3 months follow up.)
- Disability with Modified Rankin Scale(Change from baseline to immediately after training and baseline to 3 months follow up.)
- Serum brain derived neurotrophic growth factor (BDNF)(Change from baseline to immediately after training.)
- Corticomotor excitability using transcranial magnetic stimulation(Change from baseline to immediately after training and baseline to 3 months follow up.)
- Cognitive function using Mini Mental Screening Examination(Change from baseline to immediately after training and baseline to 3 months follow up.)
- Modified Ashworth Scale(Change from baseline to immediately after training and baseline to 3 months follow up.)
研究者
Sangeetha Madhavan
Professor
University of Illinois at Chicago