Independent Use of Brain Measurement-Based Rehabilitation System by Stroke Survivors: A Randomized Open Label Phase 1 Clinical Trial With Blinded Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Participation
研究概览
简要总结
The Axem Home study is a randomized open label trial analyzing the safety and feasibility of coupling the Axem Home prototype device with exercise to improve motor recovery following a stroke.
详细描述
The Axem Home study is a randomized, open label, phase I clinical trial evaluating the safety and feasibility of coupling feedback to participants on their levels of sensorimotor brain activity (via the Axem Home prototype device) with exercise rehabilitation. 15 participants will be enrolled in each arm of the study. Both groups will participate in an exercise program, but only one group (the intervention group) will receive the Axem Home prototype device.
Study participants will be evaluated at baseline, after 3 weeks, and after 6 weeks (upon the completion of their time in the Early Supported Discharge program). Evaluators will be blinded as to which group participants are in. The study is constructed with randomization to remove selection and allocation biases.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Accepted into the Calgary Stroke Program's Early Supported Discharge program for stroke survivors
- •Aged 18 or older
- •Visual acuity better than 20/50 in both eyes
- •Able to give consent
- •Clinician reported upper-extremity movement deficit
排除标准
- •Score ≥15 on the PHQ-9
- •Score <10 on the MoCA or <20 on the CASP
- •Inclusion in another interventional trial
- •Have open wounds on their scalp
结局指标
主要结局
Participation
时间窗: Intervention group only: through study completion, an average of 6 weeks
The number of participants in the intervention group that choose to discontinue participation in the study without experiencing an adverse event.
Usability Interview
时间窗: Intervention group only: once per week for an average of 6 weeks and post-intervention (after study completion, an average of week 6)
A short, semi-structured interview asking participants in the intervention group for qualitative assessments of various aspects of the Axem Home prototype device software and headband, in order to ascertain any potential areas where either might need to be improved.
Incidence of Adverse Events Related to the Axem Home Prototype Device (Safety and Tolerability)
时间窗: Intervention group only: through study completion, an average of 6 weeks
The ability of participants in the intervention group to complete the study using the Axem Home prototype device without experiencing an adverse event.
Usability Questionnaire
时间窗: Intervention group only: post-intervention (after study completion, an average of week 6)
A short questionnaire asking participants in the intervention group to rate various aspects of the Axem Home prototype device with respect to its usability and perceived usefulness.
次要结局
- Stroke Impact Scale (SIS)(Baseline, week 3, and post-intervention (after study completion, an average of week 6))
- Cognitive Assessment for Stroke Patients (CASP)(Baseline)
- Patient Health Questionnaire (PHQ-9)(Baseline)
- Montreal Cognitive Assessment (MoCA)(Baseline)
- Snellen Eye Chart Assessment of Visual Acuity(Baseline)
- Clinician Assessment of Vision(Baseline)
- Functional Independence Measure (FIM)(Baseline and post-intervention (after study completion, an average of week 6))
- Thumb Localizing Test(Baseline and post-intervention (after study completion, an average of week 6))
- Modified Rankin Scale (mRS)(Baseline and post-intervention (after study completion, an average of week 6))
- Magnetic Resonance Imaging (MRI)(Images taken from within the first week after stroke; collected during the baseline assessment)
- Modified Ashworth Scale (MAS)(Baseline and post-intervention (after study completion, an average of week 6))
- Computed Tomography Scan Imaging (CT)(Images taken from within the first week after stroke; collected during the baseline assessment)
- Change in Fugl-Meyer Assessment (FMA) of Motor Recovery(Baseline, week 3, and post-intervention (after study completion, an average of week 6))
- National Institutes of Health Stroke Scale (NIHSS)(Baseline)
- Change in Action Research Arm Test (ARAT) score(Baseline, week 3, and post-intervention (after study completion, an average of week 6))
- Strength(Baseline and post-intervention (after study completion, an average of week 6))
- Functional Near-Infrared Spectroscopy (fNIRS) Measures(Intervention group: baseline, once per week for an average of 6 weeks, and post-intervention (after study completion, an average of week 6). Control group: baseline and post-intervention (after study completion, an average of week 6))
- Recording of Assigned Home Exercises(Weekly (for an average of 6 weeks))
- Home Exercise Compliance(Weekly (for an average of 6 weeks))
- Video Capture(Intervention group only: rehabilitation sessions (for an average of 6 weeks))