Mild Traumatic Brain Injury Clinical Trial
Official title:
Sub-Symptom Aerobic Exercise Therapy to Improve Recovery From Acute Sport-Related Concussion: A Randomized Controlled Trial
NCT number | NCT02959216 |
Other study ID # | 15-012491 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 23, 2018 |
Est. completion date | July 7, 2020 |
Verified date | November 2020 |
Source | Children's Hospital of Philadelphia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The use of aerobic exercise treatment in the chronic phase of concussion recovery is well-described in the literature but there are limited existing data on the effect of exercise treatment in the acute phase after sport-related concussion (SRC). This study will compare the outcomes of adolescents with a recent SRC who are randomized to sub-threshold aerobic exercise versus those randomized to placebo stretching to evaluate the effect of aerobic exercise in the acute recovery phase.
Status | Completed |
Enrollment | 125 |
Est. completion date | July 7, 2020 |
Est. primary completion date | April 1, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 13 Years to 18 Years |
Eligibility | Inclusion Criteria (Case Subjects): - Sports-related concussion (organized or recreational). - Physician-diagnosed concussion within the last 10 days. - Symptom score difference =3 on the Post-Concussion Symptom Inventory (PCSI) Current versus PCSI Pre-Injury. - Parental/guardian permission (informed consent) and child assent. Inclusion Criteria (Control Subjects): - No known recent concussion within the past year or still causing active symptoms. - Parental/guardian permission (informed consent) and child assent. Exclusion Criteria (Case and Control Subjects): - Subjects with moderate or severe traumatic brain injury as indicated by a score <13 on Glasgow Coma Scale (GCS), presence of lesion on CT/MRI, and/or focal neurologic deficit consistent with an intracerebral lesion. - History of more than 3 diagnosed concussions. - Subjects that sustained an injury involving loss of consciousness for 30+ minutes or post-traumatic amnesia for 24+ hours. - Inability to exercise because of lower-extremity orthopedic injury, significant vestibular or visual dysfunction, or increased cardiac risk. - Pre-existing comorbidities, such as chronic pain, cardiac, neurological, or autoimmune conditions, that prevent participation in active testing and/or rehabilitation. - Currently taking medications that can affect autonomic function. - Active substance abuse/dependence. - Unwillingness to exercise or unable to access place to safely exercise. - Parental/guardian permission (informed consent) not obtainable or not provided - Cannot understand English. Exclusion Criteria (Case Subjects Only): - Additional head injury during the intervention. - Parents/ guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures. |
Country | Name | City | State |
---|---|---|---|
United States | Boston Children's Hospital | Boston | Massachusetts |
United States | University at Buffalo | Buffalo | New York |
United States | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital of Philadelphia | Boston Children's Hospital, University at Buffalo |
United States,
Leddy J, Hinds A, Sirica D, Willer B. The Role of Controlled Exercise in Concussion Management. PM R. 2016 Mar;8(3 Suppl):S91-S100. doi: 10.1016/j.pmrj.2015.10.017. Review. — View Citation
Leddy JJ, Hinds AL, Miecznikowski J, Darling S, Matuszak J, Baker JG, Picano J, Willer B. Safety and Prognostic Utility of Provocative Exercise Testing in Acutely Concussed Adolescents: A Randomized Trial. Clin J Sport Med. 2018 Jan;28(1):13-20. doi: 10.1097/JSM.0000000000000431. — View Citation
Leddy JJ, Kozlowski K, Donnelly JP, Pendergast DR, Epstein LH, Willer B. A preliminary study of subsymptom threshold exercise training for refractory post-concussion syndrome. Clin J Sport Med. 2010 Jan;20(1):21-7. doi: 10.1097/JSM.0b013e3181c6c22c. — View Citation
Leddy JJ, Willer B. Use of graded exercise testing in concussion and return-to-activity management. Curr Sports Med Rep. 2013 Nov-Dec;12(6):370-6. doi: 10.1249/JSR.0000000000000008. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to recovery | Recovery is defined as symptom resolution, exercise tolerance, and normal clinical examination. | 3 to 28 days | |
Secondary | Persistence of post-concussive symptoms | 29 to 112 days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04372797 -
Standardized Instruments to Provide Diagnostic and Prognostic Information in Mild Traumatic Brain Injury (mTBI)
|
N/A | |
Completed |
NCT01903525 -
DHA For The Treatment of Pediatric Concussion Related to Sports Injury
|
Phase 1 | |
Completed |
NCT01847040 -
Deployment Related Mild Traumatic Brain Injury (mTBI)
|
||
Completed |
NCT03678077 -
Trends in Cohabitation Status, Academic Achievement and Socio-economic Indicators After Mild Traumatic Brain Injury
|
||
Recruiting |
NCT05682677 -
Combined Neuromodulation and Cognitive Training for Post-mTBI Depression
|
N/A | |
Terminated |
NCT03345550 -
OPTIMA-TBI Pilot Study
|
Phase 2 | |
Completed |
NCT05095012 -
RECOVER Clinical Pathway for Pediatric Concussion
|
N/A | |
Recruiting |
NCT05886400 -
The Effects of Environmental Distractions on SCAT6 Outcomes
|
N/A | |
Recruiting |
NCT05262361 -
Persistent Post-Concussion Symptoms With Convergence Insufficiency
|
N/A | |
Active, not recruiting |
NCT03892291 -
Objective Dual-task Turning Measures for Return-to-duty Assessments
|
||
Completed |
NCT03688984 -
Treatment of Insomnia for Adolescents With Mild Traumatic Brain Injury
|
N/A | |
Completed |
NCT02057081 -
Multifamily Group to Reduce Marital Conflict and Disability in Veterans With mTBI
|
N/A | |
Recruiting |
NCT06233851 -
t-BIOMAP : Prospective Paediatric Cohort Study of Blood Biomarkers in mTBI
|
||
Completed |
NCT02844946 -
One-Day Life Skills Workshop for Veterans With TBI, Pain and Psychopathology
|
N/A | |
Completed |
NCT04641767 -
BIOmarkers of TRAumatic Brain Injury Spain (BIOTRABIS)
|
||
Recruiting |
NCT06112093 -
Repetitive Transcranial Magnetic Stimulation for Post-concussion Headaches
|
N/A | |
Recruiting |
NCT03819608 -
Neuromodulation and Neurorehabilitation for mTBI Plus PTSD
|
N/A | |
Withdrawn |
NCT00580918 -
Functional MRI Study of Attention in Normal Controls and Traumatic Brain Injured Patients
|
||
Completed |
NCT03319966 -
Eyetracking and Neurovision Rehabilitation of Oculomotor Dysfunction in Mild Traumatic Brain Injury
|
||
Recruiting |
NCT03846830 -
Incremental Velocity Error as a New Treatment in Vestibular Rehabilitation
|
N/A |