Sub-Threshold Exercise Treatment for Adolescents With Sports Related Concussion
| Status: | Completed |
|---|---|
| Conditions: | Neurology, Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 10 - 18 |
| Updated: | 8/30/2018 |
| Start Date: | September 2015 |
| End Date: | June 1, 2018 |
Adolescents with concussion will be randomly assigned to a treatment group where they will
receive sub-threshold exercise, or assigned to a placebo group where they will receive
structured stretching exercises. Both groups will receive standard medical coverage with
regular clinic visits. All participants will record symptoms daily on a dedicated web site.
All participants will be evaluated at time 1 with (1) structured physical exam, and (2)
structured exercise stress test which is terminated when there is symptom exacerbation. The
primary outcome measure is time to recovery where recovery is defined as (1) asymptomatic for
two consecutive days, and (2) ability to exercise to exhaustion without exacerbation of
symptoms, and (3) confirmed by a physician based on a structured physical exam.
receive sub-threshold exercise, or assigned to a placebo group where they will receive
structured stretching exercises. Both groups will receive standard medical coverage with
regular clinic visits. All participants will record symptoms daily on a dedicated web site.
All participants will be evaluated at time 1 with (1) structured physical exam, and (2)
structured exercise stress test which is terminated when there is symptom exacerbation. The
primary outcome measure is time to recovery where recovery is defined as (1) asymptomatic for
two consecutive days, and (2) ability to exercise to exhaustion without exacerbation of
symptoms, and (3) confirmed by a physician based on a structured physical exam.
Adolescents with concussion will be randomly assigned to a treatment group where they will
receive sub-threshold exercise, or assigned to a placebo group where they will receive
structured stretching exercises. Both groups will receive standard medical coverage with
regular clinic visits. All participants will record symptoms daily on a dedicated web site.
All participants will be evaluated at time 1 with (1) structured physical exam, and (2)
structured exercise stress test which is terminated when there is symptom exacerbation. The
primary outcome measure is time to recovery where recovery is defined as (1) asymptomatic for
two consecutive days, and (2) ability to exercise to exhaustion without exacerbation of
symptoms, and (3) confirmed by a physician based on a structured physical exam.
receive sub-threshold exercise, or assigned to a placebo group where they will receive
structured stretching exercises. Both groups will receive standard medical coverage with
regular clinic visits. All participants will record symptoms daily on a dedicated web site.
All participants will be evaluated at time 1 with (1) structured physical exam, and (2)
structured exercise stress test which is terminated when there is symptom exacerbation. The
primary outcome measure is time to recovery where recovery is defined as (1) asymptomatic for
two consecutive days, and (2) ability to exercise to exhaustion without exacerbation of
symptoms, and (3) confirmed by a physician based on a structured physical exam.
Inclusion Criteria:
- Adolescent with concussion injury from sports within first 10 days
Exclusion Criteria:
- Evidence of focal neurologic deficit; ADHD; history of moderate or severe TBI; greater
than 3 prior concussions (or having history of long recovery from concussion, >3
mths); inability to understand English
We found this trial at
1
site
Buffalo, New York 14215
Principal Investigator: John Leddy, MD
Phone: 917-385-7787
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