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Not yet recruitingNCT07801482Updated Oct 27, 2026

Supplementary Neuromuscular Rehabilitation During Acute Concussion Recovery

An interventional study of Exercise and Return to Activity Progression in Concussion (Diagnosis) and Gait Abnormality, sponsored by Northern Illinois University. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 24 Years. Per ClinicalTrials.gov, last updated 2026-10-27.

Sponsored by Northern Illinois University · Not applicable, Interventional, and Treatment

Updated Oct 27, 2026Design changedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 24 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Concussion (Diagnosis)
  • Gait Abnormality

Keywords

  • brain concussion
  • gait
  • symptom burden
03

In context

Brain Concussion

637 studies on the registry are indexed under Brain Concussion; 163 are open to participants now.

This study's planned enrollment of 30 is below the median of 63 across 446 interventional studies indexed under Brain Concussion.

Browse Brain Concussion studies →

Lead sponsor

Northern Illinois University is the lead sponsor of 8 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 24 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Supplementary Neuromuscular Rehabilitation

    Behavioral: Exercise

  • Active comparator
    Standard Return to Activity

    Standard Return to Activity

    Behavioral: Return to Activity Progression

Interventions

  • BehavioralExercise

    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.

    Also known as: Supplementary Neuromuscular Rehabilitation

  • BehavioralReturn to Activity Progression

    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.

06

What researchers measure

Primary outcomes

  1. Symptom Burden

    Symptom Burdent

    Time frame: Day 7 to 35

  2. Tandem Gait Performance

    Tandem Gait time to complete

    Time frame: Day 7 to 35

  3. Recovery Time

    Time to Recovery

    Time frame: Day 7 to 35

07

Study locations

1 site
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References and documents

Publications

  • 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. PubMed 33856860 ↗
  • 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. PubMed 21358497 ↗
  • 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. PubMed 29140128 ↗
  • 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. PubMed 29739302 ↗
  • 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. PubMed 37316210 ↗

Individual participant data

Plan to share: Yes — 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.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Aug 2027; primary completion for Jan 2030, 29 months later.

Of 248 non-industry interventional studies with no phase under Brain Concussion, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 47. This study's planned 29 months is close to that.

Counting every sponsor, half of 264 studies reached it within 28 months; a quarter within 19 and three quarters within 47.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 31, 2026
First posted
Sep 3, 2026
StartEst.
Aug 2, 2027
Primary completionEst.
Jan 31, 2030
CompletionEst.
Jul 31, 2030
Last update
Oct 27, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Design
Early Phase 1→Not applicable
Oct 27, 2026
Show all 1 update
  1. Oct 27, 2026
    Design Early Phase 1→Not applicable

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

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Registry details

Key details

Study ID
NCT07801482
Lead sponsor
Northern Illinois University
Responsible party
Sponsor
First posted
Sep 3, 2026
Start date
Aug 2, 2027 (estimated)
Primary completion
Jan 31, 2030 (estimated)
Completion
Jul 31, 2030 (estimated)
Last update
Oct 27, 2026

Study contacts

Tyler A Wood, PhD, LAT, ATC
Contact
twood1@niu.edu
815-753-1418

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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