IpsiHand Device Use in Hemiparetic Stroke Population to Assess Home Based EEG System Candidacy for BCI Rehabilitation of the Upper Extremity and the Efficacy of a Full Remote Home Based BCI Therapy - A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 109
- 试验地点
- 2
- 主要终点
- Fugl-Meyer - Upper Extremity (UEFM) , Manual Long Form
研究概览
简要总结
BCI-REHAB was a randomized clinical trial comparing an at-home brain-computer interface therapy system versus an at-home exercise program for upper-extremity rehabilitation in the chronic phases of stroke. The purpose of the trial was to evaluate the efficacy of BCI-based therapy tested against standard exercise therapy and assess the potential for meaningful motor improvement in the home environment.
详细描述
After meeting the inclusion criteria, all participants underwent an EEG evaluation to ensure that EEG features sufficient for device control could be detected. Participants who met the inclusion/exclusion criteria and passed the EEG test were randomly assigned (1:1) to either home-based BCI rehabilitation (BCI) or a Home Exercise rehabilitation regimen Program (HEP).
Participants were instructed to use the device for home-based therapy sessions 1 hour per day, 5 days per week, for a continuous 12 weeks. During the therapy sessions, the system would guide the patient through a series of routines in which they would imagine opening and closing their affected hand. At the instant the BCI detected sensorimotor cortex EEG spectral features associated with imagined ipsilateral hand movements, the handpiece opened and closed the participant's hand in a three-finger pinch grip.
Participants did not receive occupational or physical therapy services while participating in the self-directed BCI Therapy.
Participants allocated to the HEP control group received a structured home exercise program designed to control for non-specific motor and sensory engagement associated with the intervention. They completed an in-person baseline assessment of function and an HEP training session with an OT. The program consisted of a customized set of range of motion and functional tasks targeting the hand, wrist, elbow, and shoulder. Participants were instructed to complete 1 hour of home exercise per day, 5 days per week, over the course of 12 weeks.
The Primary outcome assessment was the in-person Upper Extremity Fugl-Meyer (UEFM) completed on day 1 (baseline) and after 12 weeks of participation.
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
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults age (18-85)
- •Adults who sustained a CVA
- •Have upper extremity hemiparesis/hemiplegia
- •Participants who are not receiving Botox Injections for the upper extremity may be included. Should a participant be receiving Botox injections for the upper extremity, they may be included but Botox administration must be timed to coincide within a week of the beginning of training.
排除标准
- •Participants who are not receiving Botox Injections for the upper extremity may be included. Should a participant be receiving Botox injections for the upper extremity, they may be included but Botox administration must be timed to coincide within a week of the beginning of training.
- •Participants who are too cognitively impaired to understand the task or provide informed consent will be excluded. A Short-Blessed Test score of 8 or more will be excluded.
- •Participants who have contractures in the affected wrist and digits will be excluded, as the device will not comfortably fit.
- •Participants who have receptive aphasia and unable to follow written directions will be excluded. A score of 6 or less on the MS Aphasia Screening Test will be excluded.
- •Participants receiving any formal upper extremity therapy will be excluded.
- •Participants with ataxia apraxia or severe psychiatric illness (other than post stroke depression) will be excluded.
- •Participants who are pregnant or breast-feeding will be excluded.
- •Participants who have nerve or sensory impairment that may limit or interfere with their ability to sense pain will be excluded.
研究组 & 干预措施
Home Based BCI Rehabilitation (BCI)
Participants were instructed to use the device for home-based therapy sessions 1 hour per day, 5 days per week, for a continuous 12 weeks.
干预措施: Neurolutions IpsiHand Upper Extremity Rehabilitation System (Device)
Home Exercise rehabilitation regimen Program (HEP)
The program consisted of a customized set of range of motion and functional tasks targeting the hand, wrist, elbow, and shoulder. Participants were instructed to complete 1 hour of home exercise per day, 5 days per week, over the course of 12 weeks.
干预措施: Home Exercise rehabilitation regimen Program (HEP) (Other)
结局指标
主要结局
Fugl-Meyer - Upper Extremity (UEFM) , Manual Long Form
时间窗: Assessed at baseline visit and at completion of study
Valid assessment tool of upper extremity motor function in persons chronic stroke with moderate to severe deficits. Lowest score 0, highest score 66.
Upper Extremity Fugl-Meyer (UEFM)
时间窗: 12 weeks
Assessment tool of upper extremity motor function. Lowest score 0, highest score 66.
Fugl-Meyer - Upper Extremity (UEFM) , Manual Long Form
时间窗: Assessed at baseline visit and at completion of study
Valid assessment tool of upper extremity motor function in persons chronic stroke with moderate to severe deficits. Lowest score 0, highest score 66.
次要结局
- Neurolutions Upper Extremity Remote Assessment (Remote Digital Fugl Meyer)(Baseline, 2 week, 4 week, 6 week, 8 week, 10 week and 12 week completion assessment)
- Pinch force (Dynamometer)(Baseline and 12 week completion assessment)
- Gross Grasp (Dynamometer)(Baseline and 12 week completion assessment)
- Motricity Index (Shoulder, Elbow, Pinch)(Baseline and 12 week completion assessment)
- Western Aphasia Battery (Bedside Record Form)(Baseline and 12 week completion assessment)
- Timed Up and Go Test (TUG)(Baseline and 12 week completion assessment)
- 10 Meter Walking Test(Baseline and 12 week completion assessment)
- Arm Motor Ability Test (4 Subtests Only)(Baseline and 12 week completion assessment)
- Trail Making Test- Parts A and B(Baseline and 12 week completion assessment)
- Modified Rankin Scale(Baseline and 12 week completion assessment)
- PHQ-9(Baseline and 12 week completion assessment)
- Neurolutions Upper Extremity Remote Assessment (Remote Digital Fugl Meyer)(Baseline, 2 week, 4 week, 6 week, 8 week, 10 week and 12 week completion assessment)
- Pinch force (Dynamometer)(Baseline and 12 week completion assessment)
- Gross Grasp (Dynamometer)(Baseline and 12 week completion assessment)
- Motricity Index (Shoulder, Elbow, Pinch)(Baseline and 12 week completion assessment)
- Western Aphasia Battery (Bedside Record Form)(Baseline and 12 week completion assessment)
- Timed Up and Go Test (TUG)(Baseline and 12 week completion assessment)
- 10 Meter Walking Test(Baseline and 12 week completion assessment)
- Arm Motor Ability Test (4 Subtests Only)(Baseline and 12 week completion assessment)
- Trail Making Test- Parts A and B(Baseline and 12 week completion assessment)
- Modified Rankin Scale(Baseline and 12 week completion assessment)
- PHQ-9(Baseline and 12 week completion assessment)
- Zarit Burden Interview (ZBI)(Baseline and 12 week completion assessment)
- The Barthel Index(Baseline and 12 week completion assessment)