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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Tyler A Wood, PhD, LAT, ATC
  • Phone Number: 815-753-1418
  • Email: twood1@niu.edu

Study Locations

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Supplementary Neuromuscular Rehabilitation
Behavioral: Exercise
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:
  • Supplementary Neuromuscular Rehabilitation
Active Comparator: Standard Return to Activity
Behavioral: Return 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Northern Illinois University

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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 2, 2027

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 31, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 2, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 3, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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