Technology Development for Physical Rehabilitation of Patients With Upper Extremity Motor Deficits
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Evaluate the functionality of rehabilitation device as reported by subjects using a 10-point Likert scale
研究概览
简要总结
Injuries and disease processes that produce upper extremity deficits are devastating to patients and their families. One potential avenue to treat these neurological disorders is through the enhancement of neural plasticity, which is the ability of the brain to reorganize and recover following insult. After a minor injury, the brain undergoes beneficial neural plasticity, compensating for altered neural activity to restore normal function. However, in the cases of moderate to severe injury and disease, e.g. spinal cord injury (SCI), insufficient or improper plasticity limits recovery, leaving patients with long-term disability. Therefore, methods that can drive robust and specific plasticity have great potential to treat neurological injuries and disease.
The Texas Biomedical Device Center (TXBDC) at UT Dallas has developed a groundbreaking therapy, called Targeted Plasticity Therapy (TPT), which pairs traditional motor, sensory, and cognitive rehabilitation with precise stimulation of the vagus nerve, to guide such robust and specific plasticity to treat a wide range of neurological deficits.
详细描述
The groundbreaking therapy developed at Texas Biomedical Device Center (TXBDC) , called Targeted Plasticity Therapy (TPT) pairs traditional motor, sensory, and cognitive rehabilitation with precise stimulation of the vagus nerve, to guide such robust and specific plasticity to treat a wide range of neurological deficits. The success of this concomitant therapy will be furthered, in part, through the development and use of mechanical devices aimed at measuring the effects of rehabilitation in patients with an upper extremity neurological deficit, e.g. from SCI. These devices are small hand controllers used to play simple video games that can also measure force and movement. Additionally, this study will be used to inform the future development of the rehabilitation game software as well as an optional game chair (in patients that use wheelchairs, the games can also be played from the patient's own chair).
To optimize the evaluation of these RePlay devices and software, and to decrease the time requirement for patients, research will be divided into two phases. Patients can participate in either one or both phases. Participation in phase II is not contingent on participation in phase I.
Phase I will involve 80 participants using the RePlay devices and games on a single visit. These 80 participants will be a collection of participants with no neurological disorders, participants recovering from stroke, those with Multiple Sclerosis, Parkinson's Disease and Spinal Cord Injuries. This will allow us to determine the ability of these patient populations to enjoyably use these devices and games compared with their degree of impairment. Participants' degree of impairment will be quantified by standard rehabilitation measurements for each disease process, including the ASIA Spinal Cord Impairment Scale, GRASSP, Jebsen Taylor Hand Function, dynomometry strength readings
In Phase II, 20 participants will be randomized equally to one of two groups. Each group will receive the same amount of therapy, only in a different sequence.
Group 1 will receive:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Partial upper limb impairment in one or both arms as a result of a neurological injury or disease
- •Age 18-65
排除标准
- •Emotional disability that would interfere with participation as determined by Dr.
- •Inability to understand instructions in English
- •No upper limb movement
- •Incarcerated individuals
- •For Phase II, anticipated inability to complete study visits
研究组 & 干预措施
Group 1
Group 1 will receive:
- Medical History and Brief Physical Exam
- Diagnostic Assessments
- Patient Instruction and use of RePlay Device
- two weeks of RePlay device therapy twice per week at REACT (weeks 1-2), followed by re-assessment,
- then will rest for 2 weeks (weeks 3-4),
- then will take the RePlay devices and tablets home for two weeks (weeks 5-6) for daily RePlay device therapy, followed by re-assessment.
干预措施: Physical exam and medical history (Other)
Group 1
Group 1 will receive:
- Medical History and Brief Physical Exam
- Diagnostic Assessments
- Patient Instruction and use of RePlay Device
- two weeks of RePlay device therapy twice per week at REACT (weeks 1-2), followed by re-assessment,
- then will rest for 2 weeks (weeks 3-4),
- then will take the RePlay devices and tablets home for two weeks (weeks 5-6) for daily RePlay device therapy, followed by re-assessment.
干预措施: Assessments (Diagnostic Test)
Group 1
Group 1 will receive:
- Medical History and Brief Physical Exam
- Diagnostic Assessments
- Patient Instruction and use of RePlay Device
- two weeks of RePlay device therapy twice per week at REACT (weeks 1-2), followed by re-assessment,
- then will rest for 2 weeks (weeks 3-4),
- then will take the RePlay devices and tablets home for two weeks (weeks 5-6) for daily RePlay device therapy, followed by re-assessment.
干预措施: Patient Instruction and use of Device (RePlay) (Device)
Group 2
Group 2 will receive:
- Medical History and Brief Physical Exam
- Diagnostic Assessments
- Patient Instruction and use of RePlay Device
- two weeks of RePlay device therapy daily at home (they will take the RePlay devices and tablets home) (weeks 1-2), followed by re-assessment,
- then will rest for 2 weeks (weeks 3-4),
- then will receive two weeks of RePlay device therapy twice per week at REACT (weeks 5-6), and then will undergo re-assessment.
干预措施: Physical exam and medical history (Other)
Group 2
Group 2 will receive:
- Medical History and Brief Physical Exam
- Diagnostic Assessments
- Patient Instruction and use of RePlay Device
- two weeks of RePlay device therapy daily at home (they will take the RePlay devices and tablets home) (weeks 1-2), followed by re-assessment,
- then will rest for 2 weeks (weeks 3-4),
- then will receive two weeks of RePlay device therapy twice per week at REACT (weeks 5-6), and then will undergo re-assessment.
干预措施: Assessments (Diagnostic Test)
Group 2
Group 2 will receive:
- Medical History and Brief Physical Exam
- Diagnostic Assessments
- Patient Instruction and use of RePlay Device
- two weeks of RePlay device therapy daily at home (they will take the RePlay devices and tablets home) (weeks 1-2), followed by re-assessment,
- then will rest for 2 weeks (weeks 3-4),
- then will receive two weeks of RePlay device therapy twice per week at REACT (weeks 5-6), and then will undergo re-assessment.
干预措施: Patient Instruction and use of Device (RePlay) (Device)
结局指标
主要结局
Evaluate the functionality of rehabilitation device as reported by subjects using a 10-point Likert scale
时间窗: Through Study Completion approximately 8-9 weeks
Assess general fit, and functionality of these devices to further the device development. both in the home and in the rehabilitation setting. This will be measured by subject report. This will be measured by subject report. Subjects will verbally provide feedback as they use the software and hardware. Feedback will be recorded and changes will be made based on feedback received from participants. Subjects self-report their experienced fit and function of RePlay using a 10-point Likert scale (10 = extremely easy to fit, 1 = didn't fit at all). Higher scores represent a greater degree of experienced fit and function
Evaluate the rehabilitation device design as reported by subjects using a 10-point Likert scale
时间窗: Through Study Completion, approximately 8-9 weeks
Assess feasibility, ease of use and enjoyment for device in injured population. This will be measured by subject report. Subjects will verbally provide feedback as they use the software and hardware. Feedback will be recorded and changes will be made based on feedback received from participants. Subjects self-report their experienced enjoyment of RePlay using a 10-point Likert scale (10 = extreme enjoyment, 1 = no enjoyment). Higher scores represent a greater degree of experienced enjoyment.
次要结局
未报告次要终点
研究者
Robert Rennaker
Professor
The University of Texas at Dallas