Spinal Stimulation to Improve Upper Extremity Recovery in the Home (SSTIM UE Recover [SURe])
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Capabilities of Upper Extremity Questionnaire (CUE-Q)
研究概览
简要总结
The purpose of this research is to evaluate the safety, feasibility, and tolerability of non-invasive spinal stimulation used in the home and/or community in combination with a functional home exercise program for the upper extremities (arm/hand function) as well as their combined impacts on changes in upper extremity function. The expected duration of participation in this study is about 31-33 hours over a 13-25-week period. Enrollees in this study will be randomly assigned to one of two groups: 1) upper extremity functional task-specific training combined with non-invasive transcutaneous spinal stimulation, or 2) waitlist control, which involves the same intervention, but with a 12-week delayed start. Participants complete initial testing (one time if in group one and three times [at weeks 0, 8, and 12] if in group two), 24 1-hour training sessions (2x/week in home with caregiver/companion support and 1x/week with research team in person or via video conference for 8 weeks), a post-treatment evaluation, and a final evaluation (4 weeks after post-treatment).
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
- Single (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 18 or older
- •History of traumatic SCI
- •Less than 12 months post SCI
- •SCI injury level C1-C8
- •SCI categorized as AIS B-D
- •Have passive range of motion (ROM) within functional limits at wrists, shoulders, and elbows
- •Have caregiver support to attend three in-person sessions and ongoing training at home
- •Have a caregiver who, in the judgment of the research team, is qualified to assist the participant in the safe use of TSS
- •Able to complete in-person training sessions and return to Craig Hospital for assessments
- •Experience no complicating physical or cognitive conditions as determined by their physician that would preclude the safe use of electrical stimulation
- •If using prescribed anti-spasticity medications, must be at a stable dose for at least four weeks prior to starting study procedures
- •Agrees to comply with investigational devices instructions for use, protocol visits, and return of the device
- •Able to provide informed consent
排除标准
- •Experience unstable chronic cardiac or respiratory complaints
- •Have a recent history of fracture, contractures, or skin pressure injuries that might interfere with the intervention
- •Received Botox injections to the UEs, neck, or hands within the last three months
- •Pregnant, planning to become pregnant, or currently breastfeeding
- •Have breakdown in skin area that will come into contact with electrodes
- •Prior nerve or tendon transfer procedure for the UEs
- •Concurrently are participating in another drug or device trial that may interfere with this study
- •Have an implanted pacemaker, spinal cord stimulator, ventriculoperitoneal shunt, deep brain stimulator, or intrathecal pump
- •In the opinion of the investigators, the study is not safe or appropriate for the participant
研究组 & 干预措施
Immediate Intervention
For the immediate intervention group, each participant will complete the following:
- Initial baseline evaluation
- 24 training sessions (3x/week for eight weeks) of UE Functional Task Practice (FTP)+TSS (two training sessions/week will be completed in the home with caregiver/companion support; the third weekly session will be conducted via videoconference with a research therapist)
- Post-treatment evaluation (after eight weeks of training) and follow-up evaluation (four weeks after post-treatment evaluation).
- Post-treatment and follow-up assessments will be conducted over two days: assessments completed without TSS on day one and with TSS on day two.
干预措施: Immediate Intervention (Behavioral)
Waitlist Control
The waitlist control group will participate in a protocol similar to the immediate intervention group, except:
- 12-week waiting period before starting the active intervention.
- Assessments will be completed at 0, 8, and 12 weeks before starting the active intervention to control for spontaneous recovery.
- Post-treatment evaluation (after eight weeks of training)
- Follow-up assessment (four weeks after the post-treatment evaluation).
干预措施: Waitlist control (Behavioral)
结局指标
主要结局
Capabilities of Upper Extremity Questionnaire (CUE-Q)
时间窗: Weeks 0, 8, 12, 21, and 25
The CUE-Q version 2.1 measures functional limitation and perceived difficulty of performing actions with upper extremities in individuals with tetraplegia. The CUE-Q has 32 items; each scored on a 1-to-7-point scale representing self-perceived difficulty with total scores ranging from 32 to 224 (higher scores demonstrating greater UE function) and right and left scores assessed separately
次要结局
- Graded Refined Assessment of Strength, Sensibility, and Prehension (GRASSP)(Weeks 0, 8, 12, 21, and 25)
- International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI)(Weeks 0, 8, 12, 21, and 25)
- Pinch and Grasp Force(Weeks 0, 8, 12, 21, and 25)
- Global Rating of Change (GRC)(Weeks 8, 12, 21, and 25)
- Satisfaction with Treatment Scale(Weeks 8, 12, 21, and 25)
- Qualitative Questions(Weeks 8 and 21)
- Canadian Occupational Performance Measure (COPM)(Weeks 0, 8, 12, 21, and 25)
- International Spinal Cord Injury Quality of Life Basic Data Set (QoL-BDS) Version 2.0(Weeks 0, 8, 12, 21, and 25)
- International Spinal Cord Injury Pain Basic Data Set (ISCIPBDS) Version 3.0(Weeks 0, 8, 12, 21, and 25)
研究者
Candace Tefertiller
Executive Director of Research and Evaluation
Craig Hospital