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Purpose

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. We hypothesize that patients who include SMART therapy as part of their treatment regimen will improve faster than patients who do not include SMART treatment. We 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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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, increased risk of depression or anxiety, as determined by a score of 3 or more on either subset of the Patient Health Questionnaire-4 [(PHQ-4) see Appendix J], 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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Factorial Assignment
Intervention Model Description
Two primary groups: one being standard of care that would include physical therapy (PT) and speech therapy/cognitive rehabilitation therapy (ST/CRT); two being standard of care (PT and ST/CRT) plus SMART sessions at different frequencies.
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Other
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.
  • Other: Physical therapy and speech therapy/cognitive rehabilitation therapy
    Standard of care for all participants will include physical therapy and speech therapy once a week to address many symptom-based issues that are often associated with post concussion syndrome. Physical therapy will address vestibular, oculomotor, headache, and other muscoloskeletal concerns. Sessions will include patient history, evaluation, assessment, manual therapy, exercises, patient education and home exercise program. Speech therapy will address cognitive concerns which may include communication, memory, and various executive functioning aspects of the brain. Sessions will include patient history, assessment, cognitive tasks and challenges, education and home exercise program.
Experimental
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.
  • Device: Sensorimotor Multi-axis Automated Rotational Therapy (SMART) utilizing GyroStim device
    GyroStim is a sensorimotor multi-axis automated rotational therapy (SMART) and used to stimulate, challenge, and improve the functional performance of the human sensorimotor system. GyroStim software allows the clinician to select and run specific, individual programs in a series of runs that present incrementally increasing intensity, duration, and cognitive challenge to help promote functional gains and achieve patient rehabilitation. GyroStim consists of a chair that is mounted to two rotational frames that are run by individual electric motors. Each axis can spin up to 360 degrees separately or simultaneously. The chair, rotational frames and pod are enclosed within a circular steel and polycarbonate frame. There are numerous safety features and an integrated targeting system subjects hit with a laser pointer to help integrate visual, vestibular and sensorimotor coordination.
  • Other: Physical therapy and speech therapy/cognitive rehabilitation therapy
    Standard of care for all participants will include physical therapy and speech therapy once a week to address many symptom-based issues that are often associated with post concussion syndrome. Physical therapy will address vestibular, oculomotor, headache, and other muscoloskeletal concerns. Sessions will include patient history, evaluation, assessment, manual therapy, exercises, patient education and home exercise program. Speech therapy will address cognitive concerns which may include communication, memory, and various executive functioning aspects of the brain. Sessions will include patient history, assessment, cognitive tasks and challenges, education and home exercise program.
Experimental
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.
  • Device: Sensorimotor Multi-axis Automated Rotational Therapy (SMART) utilizing GyroStim device
    GyroStim is a sensorimotor multi-axis automated rotational therapy (SMART) and used to stimulate, challenge, and improve the functional performance of the human sensorimotor system. GyroStim software allows the clinician to select and run specific, individual programs in a series of runs that present incrementally increasing intensity, duration, and cognitive challenge to help promote functional gains and achieve patient rehabilitation. GyroStim consists of a chair that is mounted to two rotational frames that are run by individual electric motors. Each axis can spin up to 360 degrees separately or simultaneously. The chair, rotational frames and pod are enclosed within a circular steel and polycarbonate frame. There are numerous safety features and an integrated targeting system subjects hit with a laser pointer to help integrate visual, vestibular and sensorimotor coordination.
  • Other: Physical therapy and speech therapy/cognitive rehabilitation therapy
    Standard of care for all participants will include physical therapy and speech therapy once a week to address many symptom-based issues that are often associated with post concussion syndrome. Physical therapy will address vestibular, oculomotor, headache, and other muscoloskeletal concerns. Sessions will include patient history, evaluation, assessment, manual therapy, exercises, patient education and home exercise program. Speech therapy will address cognitive concerns which may include communication, memory, and various executive functioning aspects of the brain. Sessions will include patient history, assessment, cognitive tasks and challenges, education and home exercise program.
Experimental
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.
  • Device: Sensorimotor Multi-axis Automated Rotational Therapy (SMART) utilizing GyroStim device
    GyroStim is a sensorimotor multi-axis automated rotational therapy (SMART) and used to stimulate, challenge, and improve the functional performance of the human sensorimotor system. GyroStim software allows the clinician to select and run specific, individual programs in a series of runs that present incrementally increasing intensity, duration, and cognitive challenge to help promote functional gains and achieve patient rehabilitation. GyroStim consists of a chair that is mounted to two rotational frames that are run by individual electric motors. Each axis can spin up to 360 degrees separately or simultaneously. The chair, rotational frames and pod are enclosed within a circular steel and polycarbonate frame. There are numerous safety features and an integrated targeting system subjects hit with a laser pointer to help integrate visual, vestibular and sensorimotor coordination.
  • Other: Physical therapy and speech therapy/cognitive rehabilitation therapy
    Standard of care for all participants will include physical therapy and speech therapy once a week to address many symptom-based issues that are often associated with post concussion syndrome. Physical therapy will address vestibular, oculomotor, headache, and other muscoloskeletal concerns. Sessions will include patient history, evaluation, assessment, manual therapy, exercises, patient education and home exercise program. Speech therapy will address cognitive concerns which may include communication, memory, and various executive functioning aspects of the brain. Sessions will include patient history, assessment, cognitive tasks and challenges, education and home exercise program.

Recruiting Locations

Neuroscience Group
Appleton, Wisconsin 54915
Contact:
Nichole J Siebert, MS
920-725-9373
nichole.siebert@neurosciencegroup.com

More Details

Status
Recruiting
Sponsor
Neuroscience Group

Study Contact

Nichole J Siebert, MS
920-725-9373
nichole.siebert@neurosciencegroup.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.