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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PT & ST/CRT | Other | 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. |
|
| PT & ST/CRT plus SMART twice a week | Experimental | 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. |
|
| PT & ST/CRT plus SMART up to three times a week | Experimental | 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. |
|
| PT & ST/CRT plus SMART up to four times a week | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sensorimotor Multi-axis Automated Rotational Therapy (SMART) utilizing GyroStim device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Headache Impact Test (HIT-6) | Subjective physical therapy questionnaire to evaluate extent of patient's headaches. Scores range from 36-78, with a higher score being more severe. | 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) | Subjective patient questionnaire evaluating symptoms related to concussion. Scores range from 0-132, with higher scores indicating greater symptom severity. | First physical therapy visit and last physical therapy visit (following 10 SMART sessions for intervention groups). Between 3-6 weeks. |
| Dizziness Handicap Inventory (DHI) | 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. | First physical therapy visit and last physical therapy visit (following 10 SMART sessions for intervention groups). Between 3-6 weeks. |
| Neck Disability Index (NDI) | 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. | First physical therapy visit and last physical therapy visit (following 10 SMART sessions for intervention groups). Between 3-6 weeks. |
| Functional Gait Assessment (FGA) | 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. | First physical therapy visit and last physical therapy visit (following 10 SMART sessions for intervention groups). Between 3-6 weeks. |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nichole J Siebert, MS | Contact | 920-725-9373 | nichole.siebert@neurosciencegroup.com | |
| Taylor Weuve, MBA | Contact | 920-725-9373 | taylor.weuve@neurosciencegroup.com |
| Name | Affiliation | Role |
|---|---|---|
| Benjamin Siebert, MD | Neuroscience Group | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neuroscience Group | Recruiting | Appleton | Wisconsin | 54915 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17414343 | Background | Yang CC, Tu YK, Hua MS, Huang SJ. The association between the postconcussion symptoms and clinical outcomes for patients with mild traumatic brain injury. J Trauma. 2007 Mar;62(3):657-63. doi: 10.1097/01.ta.0000203577.68764.b8. | |
| Background | Maher, K., & Hall, C. (2026). Comparative Clinical Outcomes of Physical Therapy Versus Physical Therapy Combined With GyroStim for Treatment of Post-Concussion Syndrome: A Retrospective Case Series [Unpublished manuscript]. ANOVA Healthcare, North Carolina. | ||
| Background | Heyser, B. (2023). Unpublished data collection from retrospective study utilizing GyroStim patients with concussion [Unpublished raw data]. Heyser Chiropractic Neurology @ The Brain Center, Tallahassee, FL. | ||
| 34864777 |
| Label | URL |
|---|---|
| Concussion. American Association of Neurological Surgeons | View source |
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Sharing will likely be dependent on results and findings.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 26, 2026 | Jun 5, 2026 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 4, 2026 | Apr 9, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D038223 | Post-Concussion Syndrome |
| ID | Term |
|---|---|
| D001924 | Brain Concussion |
| D016489 | Head Injuries, Closed |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
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| ID | Term |
|---|---|
| D026741 | Physical Therapy Modalities |
| D013070 | Speech Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
| D012049 | Rehabilitation of Speech and Language Disorders |
| D000359 | Aftercare |
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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.
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|
|
| Physical therapy and speech therapy/cognitive rehabilitation therapy | Other | 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. |
|
| Modified Clinical Test of Sensory Interaction in Balance (CTSIB-m) | 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. | 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) | 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. | 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 | 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. | First speech therapy visit and last speech therapy visit (following 10 SMART sessions for intervention groups). Between 3-6 weeks. |
| Background |
| Hall CD, Herdman SJ, Whitney SL, Anson ER, Carender WJ, Hoppes CW, Cass SP, Christy JB, Cohen HS, Fife TD, Furman JM, Shepard NT, Clendaniel RA, Dishman JD, Goebel JA, Meldrum D, Ryan C, Wallace RL, Woodward NJ. Vestibular Rehabilitation for Peripheral Vestibular Hypofunction: An Updated Clinical Practice Guideline From the Academy of Neurologic Physical Therapy of the American Physical Therapy Association. J Neurol Phys Ther. 2022 Apr 1;46(2):118-177. doi: 10.1097/NPT.0000000000000382. |
| 17320539 | Background | Denson K, Morgan D, Cunningham R, Nigliazzo A, Brackett D, Lane M, Smith B, Albrecht R. Incidence of venous thromboembolism in patients with traumatic brain injury. Am J Surg. 2007 Mar;193(3):380-3; discussion 383-4. doi: 10.1016/j.amjsurg.2006.12.004. |
| 32395167 | Background | Suleiman A, Lithgow BJ, Anssari N, Ashiri M, Moussavi Z, Mansouri B. Correlation between Ocular and Vestibular Abnormalities and Convergence Insufficiency in Post-Concussion Syndrome. Neuroophthalmology. 2019 Oct 9;44(3):157-167. doi: 10.1080/01658107.2019.1653325. eCollection 2020 Jun. |
| 37211140 | Background | Silverberg ND, Iverson GL; ACRM Brain Injury Special Interest Group Mild TBI Task Force members:; Cogan A, Dams-O-Connor K, Delmonico R, Graf MJP, Iaccarino MA, Kajankova M, Kamins J, McCulloch KL, McKinney G, Nagele D, Panenka WJ, Rabinowitz AR, Reed N, Wethe JV, Whitehair V; ACRM Mild TBI Diagnostic Criteria Expert Consensus Group:; Anderson V, Arciniegas DB, Bayley MT, Bazarian JJ, Bell KR, Broglio SP, Cifu D, Davis GA, Dvorak J, Echemendia RJ, Gioia GA, Giza CC, Hinds SR 2nd, Katz DI, Kurowski BG, Leddy JJ, Sage NL, Lumba-Brown A, Maas AI, Manley GT, McCrea M, Menon DK, Ponsford J, Putukian M, Suskauer SJ, van der Naalt J, Walker WC, Yeates KO, Zafonte R, Zasler ND, Zemek R. The American Congress of Rehabilitation Medicine Diagnostic Criteria for Mild Traumatic Brain Injury. Arch Phys Med Rehabil. 2023 Aug;104(8):1343-1355. doi: 10.1016/j.apmr.2023.03.036. Epub 2023 May 19. |
| 34751759 | Background | Rytter HM, Graff HJ, Henriksen HK, Aaen N, Hartvigsen J, Hoegh M, Nisted I, Naess-Schmidt ET, Pedersen LL, Schytz HW, Thastum MM, Zerlang B, Callesen HE. Nonpharmacological Treatment of Persistent Postconcussion Symptoms in Adults: A Systematic Review and Meta-analysis and Guideline Recommendation. JAMA Netw Open. 2021 Nov 1;4(11):e2132221. doi: 10.1001/jamanetworkopen.2021.32221. |
| 37316210 | Background | Patricios JS, Schneider KJ, Dvorak J, Ahmed OH, Blauwet C, Cantu RC, Davis GA, Echemendia RJ, Makdissi M, McNamee M, Broglio S, Emery CA, Feddermann-Demont N, Fuller GW, Giza CC, Guskiewicz KM, Hainline B, Iverson GL, Kutcher JS, Leddy JJ, Maddocks D, Manley G, McCrea M, Purcell LK, Putukian M, Sato H, Tuominen MP, Turner M, Yeates KO, Herring SA, Meeuwisse W. Consensus statement on concussion in sport: the 6th International Conference on Concussion in Sport-Amsterdam, October 2022. Br J Sports Med. 2023 Jun;57(11):695-711. doi: 10.1136/bjsports-2023-106898. |
| 27655831 | Background | Murray DA, Meldrum D, Lennon O. Can vestibular rehabilitation exercises help patients with concussion? A systematic review of efficacy, prescription and progression patterns. Br J Sports Med. 2017 Mar;51(5):442-451. doi: 10.1136/bjsports-2016-096081. Epub 2016 Sep 21. |
| 23474878 | Background | Laborey M, Masson F, Ribereau-Gayon R, Zongo D, Salmi LR, Lagarde E. Specificity of postconcussion symptoms at 3 months after mild traumatic brain injury: results from a comparative cohort study. J Head Trauma Rehabil. 2014 Jan-Feb;29(1):E28-36. doi: 10.1097/HTR.0b013e318280f896. |
| 19996233 | Background | Kroenke K, Spitzer RL, Williams JB, Lowe B. An ultra-brief screening scale for anxiety and depression: the PHQ-4. Psychosomatics. 2009 Nov-Dec;50(6):613-21. doi: 10.1176/appi.psy.50.6.613. |
| 20009782 | Background | Hoffer ME, Balaban C, Gottshall K, Balough BJ, Maddox MR, Penta JR. Blast exposure: vestibular consequences and associated characteristics. Otol Neurotol. 2010 Feb;31(2):232-6. doi: 10.1097/MAO.0b013e3181c993c3. |
| 12937489 | Background | Giza CC, Hovda DA. The Neurometabolic Cascade of Concussion. J Athl Train. 2001 Sep;36(3):228-235. |
| 27605923 | Background | Ellis MJ, Leddy J, Willer B. Multi-Disciplinary Management of Athletes with Post-Concussion Syndrome: An Evolving Pathophysiological Approach. Front Neurol. 2016 Aug 24;7:136. doi: 10.3389/fneur.2016.00136. eCollection 2016. |
| Concussion | View source |
| Management and Rehabilitation of Post-Acute Mild Traumatic Brain Injury Work Group | View source |
| Post Concussive Syndrome | View source |
| Shirley Ryan Lab: Functional Gate Assessment | View source |
| Shirley Ryan Lab: m-CTSIB | View source |
| D009422 |
| Nervous System Diseases |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |
| D003266 |
| Continuity of Patient Care |
| D005791 | Patient Care |