Supplementary Neuromuscular Rehabilitation During Acute Concussion Recovery
1 other identifier
interventional
30
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for early_phase_1
Started Aug 2027
Typical duration for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 31, 2026
CompletedFirst Posted
Study publicly available on registry
September 3, 2026
CompletedStudy Start
First participant enrolled
August 2, 2027
ExpectedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2030
Study Completion
Last participant's last visit for all outcomes
July 31, 2030
September 3, 2026
August 1, 2026
2.5 years
August 31, 2026
September 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Symptom Burden
Symptom Burdent
Day 7 to 35
Tandem Gait Performance
Tandem Gait time to complete
Day 7 to 35
Recovery Time
Time to Recovery
Day 7 to 35
Study Arms (2)
Supplementary Neuromuscular Rehabilitation
EXPERIMENTALStandard Return to Activity
ACTIVE COMPARATORStandard Return to Activity
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Northern Illinois University
DeKalb, Illinois, 60115, United States
Related Publications (5)
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.
PMID: 33856860BACKGROUNDLeddy 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.
PMID: 21358497BACKGROUNDLynall 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.
PMID: 29140128BACKGROUNDKardouni 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.
PMID: 29739302BACKGROUNDPatricios 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.
PMID: 37316210BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 31, 2026
First Posted
September 3, 2026
Study Start (Estimated)
August 2, 2027
Primary Completion (Estimated)
January 31, 2030
Study Completion (Estimated)
July 31, 2030
Last Updated
September 3, 2026
Record last verified: 2026-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
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.