Postural Motor Activation Deficits After mTBI; Translating Laboratory Findings to Clinical Care
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Instrumented, Modified Push & Release Test (I-mP&R) - Time to Stability
研究概览
简要总结
This work will address an important gap in physical therapy rehabilitation after concussion. Physical therapy usually focuses on how the brain processes sensory information such as inner ear and vision for balance rehabilitation, but our recent research shows that people with imbalance more often have a problem with how they can respond to imbalance (i.e., motor activation). While there are complex laboratory tools to test motor activation for balance, these tests are not practical for the clinic. The goal of this study is to create both an exercise intervention focused on motor activation after concussion and simple, but objective and instrumented (wearable sensors), clinical measures of motor activation. Objectives: This research study has three aims. 1) The investigators and study team will develop an exercise program to improve the problems with how one's body responds to imbalance (i.e., improve motor activation) after a concussion. The study team will use a Community Based Participatory Research (CBPR) approach by collaborating with a team of people with a broad range of experience related to concussion. The study team will form a Community Advisory Board (CAB) that will include patients who have had a concussion, healthcare professionals with expertise in concussion, and healthcare administrators. The CAB will contain people working in the military and civilians. 2) The investigators will compare our new motor-focused physical therapy intervention to the standard sensory focused balance intervention. The goal is to determine which intervention program is more effective in treating balance problems after a concussion. The investigators hypothesize that the motor-focused program will help patients more compared to the sensory program. 3) The investigators and study team will create and test several balance tests that can be used in the clinical without expensive research equipment to our standard research-based motor activation tests. This aim will allow the study team to determine if the clinical tests perform as well as the research-grade tests. To make the test useful to clinicians, the study team will use simpler technology like smart-phone applications, wearable sensors, and virtual reality goggles that are both affordable and practical for healthcare providers.
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)
盲法说明
The person performing the statistical analysis will be blinded.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed mTBI (concussion)
- •18-60 years of age
- •More than 2 weeks from the date of the most recent mTBI
- •Less than 6 months from the most recent mTBI
- •Persisting symptoms from the mTBI
排除标准
- •Injury, medical, or neurological illness that could explain balance issues
- •Moderate to severe substance abuse in the past month
- •Display behavior that would interfere with safety during data collection
- •Significant pain during the study period (> 7/10)
- •Pregnancy
- •Persistent use of medications that cause balance impairment during the study
- •Active in physical therapy services for mTBI symptoms
研究组 & 干预措施
Participants with motor physical therapy for mTBI
Participants in this arm of the study will receive physical therapy focused on reactive and dynamic balance exercises to improve motor activation for stability.
干预措施: Motor Activation Physical Therapy for mTBI (Other)
Standard of care physical therapy treatment for mTBI
This arm of the study will receive physical therapy in accordance with current clinical practice guidelines for mTBI treatment.
干预措施: Standard of Care Physical Therapy for mTBI (Other)
结局指标
主要结局
Instrumented, Modified Push & Release Test (I-mP&R) - Time to Stability
时间窗: Weeks 0 and 7 of study
The Instrumented, Modified Push \& Release (I-mP\&R) test quantifies reactive balance and motor activation by measuring the time required to regain stability following a controlled loss of balance. Participants are leaned just beyond their limit of stability, instructed to close their eyes, and then released unexpectedly. Wearable inertial sensors placed on the lumbar spine and bilateral feet are used to determine the instant of release and the first instant of stability, defined as lumbar acceleration magnitude less than 1.07 times gravity and angular velocity magnitude less than 14 degrees per second. The test is performed in four directions (forward, backward, left, right), and the median Time to Stability across all directions is retained as the primary outcome.
次要结局
- Patient Global Impression of Change (PGIC)(Week 7 only)
- Dizziness Handicap Inventory (DHI)(Weeks 0 and 7)
- Neurobehavioral Symptom Inventory (NSI)(Weeks 0 and 7)
- Quality of Life after Brain Injury (QOLIBRI)(Weeks 0 and 7)
- Activities-specific Balance Confidence Scale (ABC)(Weeks 0 and 7)
- PROMIS - Satisfaction with Participation in Social Roles(Weeks 0 and 7)
- Generalized Anxiety Disorder-7 (GAD-7)(Weeks 0 and 7)
- Modified Clinical Test of Sensory Integration on Balance (mCTSIB)(Weeks 0 and 7)
- Complex Turning Course (CTC)(Weeks 0 and 7)
- Complex Uneven Turning Course (CUTC)(Weeks 0 and 7)
- 10-Meter Walk Test (10MWT)(Weeks 0 and 7)
- Timed Tandem Gait(Weeks 0 and 7)
- Dynamic Visual Acuity (DVA)(Weeks 0 and 7)
- Vestibular Ocular Motor Screening (VOMS)(Weeks 0 and 7)
- Hybrid Assessment of Mobility (HAM-4)(Weeks 0 and 7)
- Automated Neuropsychological Assessment Metric (ANAM)(Weeks 0 and 7)
- Gold-Standard Laboratory Assessments: Central Sensorimotor Integration Test (CSMI)(Weeks 0 and 7)
- Patient Health Questionnaire-2 (PHQ-2)(Weeks 0 and 7)
- Brief Resilience Scale (BRS)(Weeks 0 and 7)
- Neck Disability Index (NDI)(Weeks 0 and 7)
- Convergence Insufficiency Symptom Survey (CISS)(Weeks 0 and 7)
- Fear Avoidance after Concussion Tool (FACT)(Weeks 0 and 7)
- Modified Fatigue Impact Scale (MFIS)(Weeks 0 and 7)
- Lower Extremity Functional Scale (LEFS)(Weeks 0 and 7)
- Dual-Task Questionnaire (DTQ)(Weeks 0 and 7)
- Balance Recovery Confidence (BRC) Scale(Weeks 0 and 7)
- Uneven 10-Meter Walk Test (U10MWT)(Weeks 0 and 7)
- 1-Minute Walk Test (1MWT)(Weeks 0 and 7)
- 1-Minute Walk Dual-Task (Serial 3s)(Weeks 0 and 7)
- The Visual Vertigo Analogue Scale-6 (VVAS-6)(Week 0 and Week 7)
研究者
Laurie King
Professor
Oregon Health and Science University