Recruiting

SMART

Sponsor:

Neuroscience Group

Code:

NCT07527663

Conditions

Post Concussion Syndrome

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Sensorimotor Multi-axis Automated Rotational Therapy (SMART) utilizing GyroStim device

Physical therapy and speech therapy/cognitive rehabilitation therapy

Study Details

Brief summary:

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.

Conditions

Post Concussion Syndrome

Study ID

NCT07527663

Start date

Mar 16, 2026

Status verified date

Jun, 2026

Completion date

Sep 30, 2027

Anticipated

Primary completion date

Sep 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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, 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

Enrollment

128 participants

Anticipated

Allocation

Non randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

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.

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.

Interventions

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.

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.

Primary outcome measure

  • Headache Impact Test (HIT-6) [ Time Frame: First physical therapy visit and last physical therapy visit (following 10 SMART sessions for intervention groups). Between 3-6 weeks. ]
  • Post Concussion Symptom Scale (PCSS) [ Time Frame: First physical therapy visit and last physical therapy visit (following 10 SMART sessions for intervention groups). Between 3-6 weeks. ]
  • Dizziness Handicap Inventory (DHI) [ Time Frame: First physical therapy visit and last physical therapy visit (following 10 SMART sessions for intervention groups). Between 3-6 weeks. ]
  • Neck Disability Index (NDI) [ Time Frame: First physical therapy visit and last physical therapy visit (following 10 SMART sessions for intervention groups). Between 3-6 weeks. ]
  • Functional Gait Assessment (FGA) [ Time Frame: First physical therapy visit and last physical therapy visit (following 10 SMART sessions for intervention groups). Between 3-6 weeks. ]
  • Modified Clinical Test of Sensory Interaction in Balance (CTSIB-m) [ Time Frame: First physical therapy visit and last physical therapy visit (following 10 SMART sessions for intervention groups). Between 3-6 weeks. ]
  • Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) [ Time Frame: First speech therapy visit and last speech therapy visit (following 10 SMART sessions for intervention groups). Between 3-6 weeks. ]
  • Rivermeade Post-Concussion Symptom Questionnaire [ Time Frame: First speech therapy visit and last speech therapy visit (following 10 SMART sessions for intervention groups). Between 3-6 weeks. ]

Central Contacts and Locations

Central contacts

Nichole J Siebert, MS

920-725-9373nichole.siebert@neurosciencegroup.com

Taylor Weuve, MBA

920-725-9373taylor.weuve@neurosciencegroup.com

Locations

Neuroscience Group

Recruiting

Appleton, Wisconsin, United States, 54915

Contacts

Nichole J Siebert, MS

920-725-9373nichole.siebert@neurosciencegroup.com

Taylor Weuve, MBA

920-725-9373taylor.weuve@neurosciencegroup.com

Principal Investigator:

Nichole Siebert, MS

More Information

Sponsor

Neuroscience Group

Last update posted

Jun 10, 2026

Last verified

Jun, 2026

Keywords

  • Post Concussion Syndrome
  • Sensorimotor Multi-axis Automated Rotational Therapy (SMART)
  • GyroStim

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Neuroscience Group on 2026-06-10.