Effectiveness of Sensorimotor Multi-axis Automated Rotational Therapy (SMART) for Post-Concussion Syndrome Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Headache Impact Test (HIT-6)
研究概览
简要总结
The goal of this study is to evaluate the efficacy of using sensorimotor multi-axis automated rotational therapy (SMART) to help treat post concussion syndrome (PCS) in adults.
The investigators hypothesize that patients who include SMART therapy as part of their treatment regimen will improve faster than patients who do not include SMART treatment.
The investigators hypothesize that patients whose treatment approach includes SMART will improve to a greater extent in their primary outcome measures than patients whose treatment approach did not include SMART.
The primary study endpoints are Post Concussion Symptom Scale (PCSS), Headache Impact Severity (HIT-6), Neck Disability Index (NDI), Dizziness Handicap Inventory (DHI), Functional Gait Assessment (FGA), Modified Clinical Test of Sensory Interaction in Balance (CTSIB-m), Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), and the Rivermeade Post-Concussion Symptom Questionnaire. These assessments will be performed before, midway, and after intervention.
Researchers will compare study endpoints to subjects that proceed with standard of care treatments in physical therapy (PT) and speech therapy/cognitive rehabilitation therapy (ST/CRT).
All participants will complete baseline testing in both PT and ST/CRT, and will continue with treatment in each therapy once a week. Intervention subjects will also complete 10 SMART session utilizing GyroStim, at a frequency of 2, 3 or 4 times a week. Follow up testing will happen in PT and ST/CRT after completion of 10 SMART sessions, or during their 6th PT and ST/CRT visit.
Statistical analysis will look compare groups to evaluate efficacy of SMART intervention, as well as evaluate efficacy of therapeutic frequency.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
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
- •A history of closed head injury and a current diagnosis of mTBI with persistent symptoms (≥ 4 weeks) consistent with persistent post-concussion syndrome (PPCS) or post-concussion syndrome (PCS) is the primary criteria for inclusion into the study. Subjects must also have a diagnosis of imbalance, dizziness or other relevant vestibular dysfunction. A diagnosis of relevant cognitive deficits or difficulties is required to qualify for ST/CRT. Any cognitive deficits or difficulties must be related to mTBI/concussion and must not be to the extent that would negate a subject's ability to consent themselves. Subjects must be at least 18 years of age and able to communicate verbally and be competent to consent.
- •Subjects may have received care for their concussion and related symptoms from other providers prior to seeking care at Neuroscience Group. Providing they meet the above criteria, they will not be excluded from participation, as long as they are not doing PT or ST/CRT concurrently or have previously done SMART elsewhere for the treatment of this head injury.
排除标准
- •include those patients under 18 years of age, those not competent to consent, those with a concussion that occurred less than 4 weeks prior to initial visit, weighing greater than 400lbs, greater than 7ft tall, those unable to communicate verbally, pregnant, less than 12 weeks post-partum, active benign paroxysmal positional vertigo (BPPV), severe claustrophobia, uncontrolled hypertension, uncontrolled seizures, ankylosing spondylitis, concern for postural cardiac issues, active cervical radiculopathy or active cauda equina symptoms, Chiari malformation Type II-IV, detached retina, or severe limitations with cervical range of motion. Other exclusions include those with neurological disorders including multiple sclerosis and Parkinson's, severe depression or anxiety, those with hearing impairments, and significant vision dysfunction, and recent upper extremity injury.
- •As pregnancy is an exclusion, medical staff will have potential female subjects fill out a pregnancy questionnaire (see Appendix K) to determine if pregnancy is a possibility. If it is possible, the subject will be given a form (see Appendix L) and provided with a home pregnancy test and package instructions (or they may use their own), which will need to be filled out and returned at the beginning of their first therapy visit. The home pregnancy test will need to be done within 3 days of their first visit. They will also be advised to continue with proper contraception or abstinence, and they will also be informed that should they become pregnant, they will need to notify a member of our medical staff at Neuroscience Group as soon as possible.
- •Exclusions with special consideration and approval from provider may include post-surgical patients (must be greater than 8-12 weeks post-op to participate and may request approval from surgeon). Patients that receive care prior to the 4 week date post-concussion, may potentially still participate, depending on the care received. This will be up to the discretion of our physician or nurse practitioner, if they feel it has significantly altered their expected prognosis or recovery timeline that could affect the study results.
- •Prescription anticoagulant medication use such as warfarin, heparin, lovenox and others will exclude a patient from participation. Over the counter aspirin use will not exclude a patient. Vitals including blood pressure, SpO2 and heart rate are taken prior to participating in GyroStim to help screen for potential issues. As always, the well-being of our patients is primary concern, and if the physician or nurse practitioners feel participation in this study due to medications is an unnecessary risk, the patient will be excluded from consideration.
研究组 & 干预措施
PT & ST/CRT
Standard of care treatment for post concussion syndrome. Includes physical therapy once a week and speech therapy/cognitive rehabilitation therapy once a week for 5 weeks or 6 total visits.
干预措施: Physical therapy and speech therapy/cognitive rehabilitation therapy (Other)
PT & ST/CRT plus SMART up to three times a week
Includes physical therapy once a week and speech therapy/cognitive rehabilitation therapy once a week plus SMART up to three times a week for 10 sessions. Last PT & ST/CRT occur once SMART sessions are completed.
干预措施: Sensorimotor Multi-axis Automated Rotational Therapy (SMART) utilizing GyroStim device (Device)
PT & ST/CRT plus SMART up to four times a week
Includes physical therapy once a week and speech therapy/cognitive rehabilitation therapy once a week plus SMART sessions up to four times a week for 10 sessions. Last PT & ST/CRT occur once SMART sessions are completed.
干预措施: Sensorimotor Multi-axis Automated Rotational Therapy (SMART) utilizing GyroStim device (Device)
PT & ST/CRT plus SMART twice a week
Includes physical therapy once a week and speech therapy/cognitive rehabilitation therapy once a week plus SMART twice a week for 10 sessions. Last PT & ST/CRT occur once SMART sessions are completed.
干预措施: Sensorimotor Multi-axis Automated Rotational Therapy (SMART) utilizing GyroStim device (Device)
PT & ST/CRT plus SMART twice a week
Includes physical therapy once a week and speech therapy/cognitive rehabilitation therapy once a week plus SMART twice a week for 10 sessions. Last PT & ST/CRT occur once SMART sessions are completed.
干预措施: Physical therapy and speech therapy/cognitive rehabilitation therapy (Other)
PT & ST/CRT plus SMART up to three times a week
Includes physical therapy once a week and speech therapy/cognitive rehabilitation therapy once a week plus SMART up to three times a week for 10 sessions. Last PT & ST/CRT occur once SMART sessions are completed.
干预措施: Physical therapy and speech therapy/cognitive rehabilitation therapy (Other)
PT & ST/CRT plus SMART up to four times a week
Includes physical therapy once a week and speech therapy/cognitive rehabilitation therapy once a week plus SMART sessions up to four times a week for 10 sessions. Last PT & ST/CRT occur once SMART sessions are completed.
干预措施: Physical therapy and speech therapy/cognitive rehabilitation therapy (Other)
结局指标
主要结局
Headache Impact Test (HIT-6)
时间窗: First physical therapy visit and last physical therapy visit (following 10 SMART sessions for intervention groups). Between 3-6 weeks.
Subjective physical therapy questionnaire to evaluate extent of patient's headaches. Scores range from 36-78, with a higher score being more severe.
Post Concussion Symptom Scale (PCSS)
时间窗: First physical therapy visit and last physical therapy visit (following 10 SMART sessions for intervention groups). Between 3-6 weeks.
Subjective patient questionnaire evaluating symptoms related to concussion. Scores range from 0-132, with higher scores indicating greater symptom severity.
Dizziness Handicap Inventory (DHI)
时间窗: First physical therapy visit and last physical therapy visit (following 10 SMART sessions for intervention groups). Between 3-6 weeks.
Subjective physical therapy questionnaire to evaluate extent and impact of patient's complaints and symptoms of dizziness. Scores range from 0-100, with higher scores indicating greater symptom severity.
Neck Disability Index (NDI)
时间窗: First physical therapy visit and last physical therapy visit (following 10 SMART sessions for intervention groups). Between 3-6 weeks.
Subjective physical therapy questionnaire to evaluate the extent and impact of a patient's complaints with neck pain and motion deficits. Scores range from 0-100%, with a higher percentage indicating more severe disability due to neck pain.
Functional Gait Assessment (FGA)
时间窗: First physical therapy visit and last physical therapy visit (following 10 SMART sessions for intervention groups). Between 3-6 weeks.
Objective physical therapy assessment to evaluate patient's balance while ambulating. Scores range from 0-30, with high scores indicating a more normal gait, and lower scores indicating abnormality.
Modified Clinical Test of Sensory Interaction in Balance (CTSIB-m)
时间窗: First physical therapy visit and last physical therapy visit (following 10 SMART sessions for intervention groups). Between 3-6 weeks.
Objective physical therapy assessment to evaluate a patient's balance while standing. Scoring is based off of time, from 0-120 seconds. The higher the score, the more normal a person's balance.
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
时间窗: First speech therapy visit and last speech therapy visit (following 10 SMART sessions for intervention groups). Between 3-6 weeks.
Objective speech therapy test administered to evaluate patient's extent of cognitive deficits. Scores range from 200-800, and can be interpreted into percentiles. The higher the score, the better the individual's cognitive function.
Rivermeade Post-Concussion Symptom Questionnaire
时间窗: First speech therapy visit and last speech therapy visit (following 10 SMART sessions for intervention groups). Between 3-6 weeks.
Subjective speech therapy questionnaire to evaluate extent of patient's symptoms related to concussion. Scores range from 0-72, with a higher score indicating more severe symptoms.
次要结局
未报告次要终点