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Supplementary Neuromuscular Rehabilitation During Acute Concussion Recovery

NCT07801482 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-09-03

No results posted yet for this 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.

Conditions

  • Concussion (Diagnosis)
  • Gait Abnormality

Interventions

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.

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.

Sponsors & Collaborators

  • Northern Illinois University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
24 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2027-08-02
Primary Completion
2030-01-31
Completion
2030-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07801482 on ClinicalTrials.gov