- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07801482
Supplementary Neuromuscular Rehabilitation During Acute Concussion Recovery
September 2, 2026 updated by: Northern Illinois University
Approximately 1.6 to 3.8 million mild traumatic brain injuries, or concussions, occur yearly in the United States.
Although most individuals progress through return-to-activity (RTA) using symptom-guided aerobic and functional activity, current protocols do not directly target neuromuscular deficits linked to persistent movement alterations after concussion.
These deficits include altered gait, reduced movement efficiency, and biomechanical changes that persist beyond symptom resolution and increase subsequent risk of musculoskeletal injury.
This creates a critical clinical gap: patients are cleared using symptom-tolerance protocols, while concussion-related neuromuscular impairments remain untreated during the period when recovery behaviors are established.
The proposed project addresses this gap by testing a low-cost, equipment-free neuromuscular rehabilitation strategy added to standard RTA during acute concussion recovery.
The intervention applies the six principles of clinical Pilates, concentration, control, centering, precision, flow, and breathing, through ten therapeutic movements designed to improve posture, flexibility, balance, strength, muscle control, body awareness, and movement confidence.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
30
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Tyler A Wood, PhD, LAT, ATC
- Phone Number: 815-753-1418
- Email: twood1@niu.edu
Study Locations
-
-
Illinois
-
DeKalb, Illinois, United States, 60115
- Northern Illinois University
-
Contact:
- Tyler A Wood, PhD, LAT, ATC
- Phone Number: 815-753-1418
- Email: twood1@niu.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- aged 18 to 24 years old
- be a registered member of an intercollegiate sports team
- have received a medically confirmed concussion within 7 days of the initial study visit.
Exclusion Criteria:
- moderate or severe traumatic brain injury
- red-flag signs or symptoms requiring urgent medical evaluation
- current lower-extremity injury that prevents safe walking or therapeutic exercise
- a neurological or vestibular disorder unrelated to concussion that independently affects balance or gait
- an uncorrected visual impairment that prevents completion of testing
- any medical condition that prevents participation in symptom-guided physical activity
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Supplementary Neuromuscular Rehabilitation
|
The intervention will include 10 standardized exercises: pelvic tilts, bridging, seated spinal twists, bent-knee fallouts, supine toe taps, clamshells, side-lying leg lifts, supine side-to-sides, quadruped arm and leg reach, and standing roll downs.
Not every exercise will be performed during every session.
Exercise selection will follow a prespecified intervention framework designed to provide consistent exposure to the major movement domains of the protocol while permitting symptom-guided modification.
The standardized protocol will identify the exercises eligible for each stage of progression and the criteria required to advance to more demanding movements.
Research personnel will select exercises from the appropriate stage based on the participant's current tolerance, symptom response, movement quality, and prior session performance.
Other Names:
|
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Active Comparator: Standard Return to Activity
|
A research team member will attend each RTA session to collect symptom ratings immediately before and after the session.
Assessments will occur whenever the athlete completes an RTA session, up to five days per week, between days 7 and 35 after concussion.
These repeated observations will characterize symptom response to standard RTA throughout recovery.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Symptom Burden
Time Frame: Day 7 to 35
|
Symptom Burdent
|
Day 7 to 35
|
|
Tandem Gait Performance
Time Frame: Day 7 to 35
|
Tandem Gait time to complete
|
Day 7 to 35
|
|
Recovery Time
Time Frame: Day 7 to 35
|
Time to Recovery
|
Day 7 to 35
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Leddy JJ, Baker JG, Kozlowski K, Bisson L, Willer B. Reliability of a graded exercise test for assessing recovery from concussion. Clin J Sport Med. 2011 Mar;21(2):89-94. doi: 10.1097/JSM.0b013e3181fdc721.
- 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.
- Kardouni JR, Shing TL, McKinnon CJ, Scofield DE, Proctor SP. Risk for Lower Extremity Injury After Concussion: A Matched Cohort Study in Soldiers. J Orthop Sports Phys Ther. 2018 Jul;48(7):533-540. doi: 10.2519/jospt.2018.8053. Epub 2018 May 8.
- Howell DR, Hunt DL, Aaron SE, Meehan WP 3rd, Tan CO. Influence of Aerobic Exercise Volume on Postconcussion Symptoms. Am J Sports Med. 2021 Jun;49(7):1912-1920. doi: 10.1177/03635465211005761. Epub 2021 Apr 15.
- Lynall RC, Mauntel TC, Pohlig RT, Kerr ZY, Dompier TP, Hall EE, Buckley TA. Lower Extremity Musculoskeletal Injury Risk After Concussion Recovery in High School Athletes. J Athl Train. 2017 Nov;52(11):1028-1034. doi: 10.4085/1062-6050-52.11.22. Epub 2017 Nov 15.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
August 2, 2027
Primary Completion (Estimated)
January 31, 2030
Study Completion (Estimated)
July 31, 2030
Study Registration Dates
First Submitted
August 31, 2026
First Submitted That Met QC Criteria
September 2, 2026
First Posted (Actual)
September 3, 2026
Study Record Updates
Last Update Posted (Actual)
September 3, 2026
Last Update Submitted That Met QC Criteria
September 2, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Injuries, Traumatic
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Wounds and Injuries
- Pathologic Processes
- Craniocerebral Trauma
- Trauma, Nervous System
- Head Injuries, Closed
- Wounds, Nonpenetrating
- Brain Injuries
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Disease
- Brain Concussion
- Mobility Limitation
- Motor Activity
- Movement
- Musculoskeletal Physiological Phenomena
- Musculoskeletal and Neural Physiological Phenomena
- Exercise
Other Study ID Numbers
- HS27-0032
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
The following data will be available through the NICDH DASH Center: Age, sex at birth, standard height, measured weight, overall symptom score, tandem gait time value, and time to recovery.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.