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Completed

NCT Number: NCT02344446

Physical Therapy Intervention for Extended Physical Symptoms After a Sports-related Concussion

The purpose of this study is to investigate if skilled physical therapy treatment for dizziness after sports-related concussion, delivered after greater than 30 days post-concussion is effective to remediate physical symptoms. This will be the first study that explores differential PT treatment for dizziness in concussed athletes who have physical symptoms 30+ days after concussion. The findings of this important research have great potential to influence clinical practice and place increased emphasis on and acceptance of manual skills and neuromotor training in the treatment of concussed patients with dizziness.

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Key information

About this study

Patients will be recruited from the ongoing Randomized Clinical Trial (Walsh University HSR 14-20) that are not returned to play and/or are not asymptomatic at the completion of their involvement in this research protocol. Based on the timeframe for their participation in the aforementioned study, these athletes will be 30 - 50 days post-concussion. At their final visit for the RCT, patients with one of the following criteria will be invited to participate in this research study:

  • Lack of release for Return to Play
  • Continuation of physical symptoms (headache, nausea, vomiting, balance problems, dizziness, light or noise sensitivity, numbness and/or vision problems) as recorded on the Post-Concussion Symptom Scale.

Desired sample size: 15 participants.

Skilled treatment: patients will be scheduled for a physical therapy assessment. The PTs will use a prescriptive approach to the assessment of the central nervous system, the cervical spine, and the vestibular system to determine the relative involvement of each system and dysfunction contributing to the patient's physical complaints. This assessment will include the outcome measures that will be obtained pre and post-treatment (Vertigo Symptom Scale (VSS) and the Functional Gait Assessment (FGA). Once the assessment is completed, the PT will initiate treatment, with follow-up visits for PT treatment 1 - 2 times per week. They will pragmatically design an individualized and progressive treatment plan, including manual therapy (manipulation and/or mobilization), neuromotor control strategies, and vestibular rehabilitation techniques, depending on the findings at assessment and patient response. Therapists can also tailor education regarding mental and physical rest according to specific parameters provided by the treating physician. Patients may also be prescribed a home exercise program and exercise education. The precise treatment strategies will be recorded. At each PT visit, symptomatic recovery will be tracked using the PCS.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients will be recruited from the ongoing Randomized Clinical Trial (Walsh University HSR 14-20) that are not returned to play and/or are not asymptomatic at the completion of their involvement in this research protocol. Based on the timeframe for their participation in the aforementioned study, these athletes will be 30 - 50 days post-concussion. At their final visit for the RCT, patients with one of the following criteria will be invited to participate in this research study:
  • Lack of release for Return to Play
  • Continuation of physical symptoms (headache, nausea, vomiting, balance problems, dizziness, light or noise sensitivity, numbness and/or vision problems) as recorded on the Post-Concussion Symptom Scale

Exclusion criteria

  • Any one who is not enrolled in the aforementioned RCT

Treatment and study plan

Skilled Therapy

Other

Active physical therapy treatment

Primary outcomes

  1. Symptomatic Recovery

    Time frame: Within 6 months of enrollment

    Using the Post-Concussion Symptom Scale, self-reported symptomatic presentation will be tracked at each visit

  2. Return to Play

    Time frame: Within 6 months of enrollment

    The treating physician will determine when return to play should be initiated.

Sponsors and collaborators

Lead sponsor

Walsh University

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jan 26, 2015
Registry last updated
Feb 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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