Concussion (Diagnosis)NCT07801482
Supplementary Neuromuscular Rehabilitation During Acute Concussion Recovery
A study testing Exercise and Return to Activity Progression in people with Concussion (Diagnosis) and Gait Abnormality, run by Northern Illinois University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 24 years
- Conditions the study is for
- Concussion (Diagnosis), Gait Abnormality
- What is being tested?
- Exercise and Return to Activity Progression
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Aug 2027to 31 Jul 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 24 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Northern Illinois University
DeKalb, Illinois, 60115
Tyler A Wood, PhD, LAT, ATC, 815-753-1418, twood1@niu.edu
About this study
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.
- Conditions
- Concussion (Diagnosis), Gait Abnormality
- Being tested
- Exercise, Return to Activity Progression
- Keywords
- brain concussion, gait, symptom burden
- Medical subject headings
- Brain Concussion, Disease, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Also called 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.
Return to Activity ProgressionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Supplementary Neuromuscular Rehabilitation | Experimental | Not described Receives: Behavioral: Exercise |
| Standard Return to Activity | Active comparator | Standard Return to Activity Receives: Behavioral: Return to Activity Progression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom Burden
Symptom Burdent
Measured: Day 7 to 35
Tandem Gait Performance
Tandem Gait time to complete
Measured: Day 7 to 35
Recovery Time
Time to Recovery
Measured: Day 7 to 35
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study start2 Aug 2027 (estimated)
- Primary completion31 Jan 2030 (estimated)
- Study completion31 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Concussion (Diagnosis)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northern Illinois University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07801482
- Sponsor's protocol ID
- HS27-0032
- Status last verified
- Aug 2026
- First submitted
- 31 Aug 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
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 33856860Leddy 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 21358497Lynall 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 29140128Kardouni 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 29739302Patricios 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
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supplementary Neuromuscular Rehabilitation During Acute Concussion Recovery
- ClinicalTrials.gov ID
- NCT07801482
- Acronym / sponsor ID
- HS27-0032
- Conditions
- Concussion (Diagnosis), Gait Abnormality
- Keywords
- brain concussion, gait, symptom burden
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Northern Illinois UniversityUniversity, hospital or other
- Study start
- 2 Aug 2027 (estimated)
- Primary completion
- 31 Jan 2030 (estimated)
- Study completion
- 31 Jul 2030 (estimated)
- First posted
- 3 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supplementary Neuromuscular Rehabilitation | Experimental | Behavioral: Exercise |
| Standard Return to Activity | Active comparator | Behavioral: Return to Activity ProgressionStandard Return to Activity |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseAlso: Supplementary Neuromuscular RehabilitationThe 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. | Behavioural | Supplementary Neuromuscular Rehabilitation |
| Return to Activity ProgressionA 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. | Behavioural | Standard Return to Activity |
Primary outcome
Symptom Burden
Time frame: Day 7 to 35
Symptom Burdent
Tandem Gait Performance
Time frame: Day 7 to 35
Tandem Gait time to complete
Recovery Time
Time frame: Day 7 to 35
Time to Recovery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Background: PubMed 33856860Howell 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.
- Background: PubMed 21358497Leddy 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.
- Background: PubMed 29140128Lynall 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.
- Background: PubMed 29739302Kardouni 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.
- Background: PubMed 37316210Patricios 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and Return to Activity Progression in people with Concussion (Diagnosis) and Gait Abnormality, run by Northern Illinois University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tyler A Wood, PhD, LAT, ATC (815-753-1418, twood1@niu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom Burden (time frame: Day 7 to 35). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07801482, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.