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Clinical Trials/NCT07801482
NCT07801482Not yet recruitingPhase 1

Supplementary Neuromuscular Rehabilitation During Acute Concussion Recovery

Northern Illinois University1 site in 1 country30 target enrollmentStarted: August 2, 2027Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 1
Status
Not yet recruiting
Enrollment
30
Locations
1
Primary Endpoint
Tandem Gait Performance

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 24 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Supplementary Neuromuscular Rehabilitation

Experimental

Intervention: Exercise (Behavioral)

Standard Return to Activity

Active Comparator

Standard Return to Activity

Intervention: Return to Activity Progression (Behavioral)

Outcomes

Primary Outcomes

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

Symptom Burden

Time Frame: Day 7 to 35

Symptom Burdent

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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