Assessing the Effects of a Clinical Exercise Protocol on Children With Post-concussion Syndrome
Withdrawn before enrolling · Not applicable
Conditions studied: Post Concussion Syndrome
In brief
The general consensus in sports medicine demonstrates a graduated return to activity protocol for individuals with post-concussion syndrome. This is commonly practiced but there is insufficient literature to indicate evidence-based practice. This study will provide evidence of the effectiveness of the clinical gradual return to exercise protocols beginning after diagnosis of post-concussion syndrome through standardization and measurement of outcomes.
Key facts
- Study ID
- NCT02459145
- Run by
- University of Arizona
- People needed
- 0
- Starts
- 2015-06-01
- Expected to finish
- 2017-05-01
- Last updated by the study team
- 2016-01-26
Who can join
Age: 13 and older, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Between the ages of 13 and 18 (freshman - senior)
- Subject must be able to understand and sign assent form and parent/guardian must be able to understand and sign consent form
- Initial injury meets the definition of mTBI as follows:
- a. Traumatically induced physiological disruption of brain function by at least one of the following: i. Any period of loss of consciousness of 30 minutes or less ii. Any loss of memory for events immediately before or after accident and post-traumatic amnesia not greater than 24 hours iii. Any alteration in mental state at time of accident b. No structural lesions in the head or brain
- Diagnosed with post concussive syndrome as follows:
- a. Clinical SCAT-3 revised score of >22 at 3+ weeks or plateaued score for 2 weeks or more of >15 at 4+ weeks
- Continues to experience symptoms post injury and at time of enrollment
- Has had a normal MRI
- Can commit to participating for 12 weeks
You may not qualify if…
- Subjects who meet any of the following criteria will be excluded from study participation:
- Any documented structural lesions in the skull or brain
- Borderline TBI or concern that TBI is moderate rather than mild
- Any medication or condition that elevates heart rate
Where it is running
- University of Arizona — Tucson, Arizona, United States
Full record on ClinicalTrials.gov
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