Brain Concussion Clinical Trial
Official title:
A Feasibility Study for a Randomized Controlled Trial on the Effectiveness of Early Physical Therapy Intervention for Patients With Dizziness After a Sports-Related Concussion
Verified date | February 2016 |
Source | Walsh University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
Therefore, the purpose of this pilot study is to determine the feasibility of conducting a
randomized clinical trial (RCT) on physical therapist treatment for dizziness after
sports-related concussion. The specific research question for this pilot RCT is: What is the
feasibility of conducting a RCT on athletes who have dizziness 10 or greater days after a
sports-related concussion to explore the effectiveness of directed vestibular
rehabilitation, neuromotor retraining, and/or manual physical therapy (PT) when compared to
sham treatment? The findings of this study (for both feasibility and effect size) will be
used to inform and direct revisions to the methods for a larger RCT on this population.
Primary Aims:
Specific Aim 1: Assess the feasibility of the following: recruitment and retention of
participants, required resources for project management, and assessment of patient safety.
Specific Aim 2: Estimate the size of the effect between skilled physical therapist
intervention and a sham treatment for the recovery rate for athletes with a concussion who
have dizziness 10 - 14 days post-concussion.
Status | Completed |
Enrollment | 41 |
Est. completion date | January 2016 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 10 Years to 23 Years |
Eligibility |
Inclusion Criteria: - Patients age 10 - 23 who have sustained a sports-related concussion. - Sports will include participation in any organized sporting activity (including club teams, recreational sports, or school teams). - Patients with a history of learning disorders, use of medication (including psychotropics or narcotics) will be included. Exclusion Criteria: - Patients younger than 10 years or older than 23 years of age. - If the patient has a concussion that was sustained during activities other than sports-related (bicycle accident, motor vehicle accident, or other non-sports related activities) they will not be enrolled in this study. - Athletes with concussion who have symptoms but none of their complaints include dizziness or indicate a postural/vestibular/ocular or perceptual abnormality will be excluded. - Finally, athletes who present to the sports-medicine physician for an initial assessment greater than 14 days after they sustained a concussion will be excluded. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Walsh University | North Canton | Ohio |
Lead Sponsor | Collaborator |
---|---|
Walsh University | American Academy of Orthopaedic Manual Therapists, Children's Hospital Medical Center of Akron, Kent State University, Ohio Physical Therapy Association |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Symptom recovery as measured by the Post Concussion Symptom (PCS) Score | 7 point Likert scale (0 - 6) rating the severity of 22 symptoms commonly associated with concussion. | Final visit (by the end of 4 weeks of treatment) | No |
Primary | Return to Play (RTP) | Five stage progressive increase in physical activity ranging from minimal exertion to full contact in a game | Final visit (by the end of 4 weeks of treatment) | No |
Secondary | Change Score of Functional Gait Assessment | Used to test balance with gait activities. | Initial assessment and final visit (by the end of 4 weeks of treatment) | No |
Secondary | Change score of Vertigo Symptom Scale - Short Form | Frequency of various types and durations of sensation of dizziness | Initial assessment and final visit (by the end of 4 weeks of treatment) | No |
Secondary | Global Response to Treatment | Global perception of change in physical symptoms from the beginning of treatment to the end | Final Visit (by the end of 4 weeks of treatment) | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Enrolling by invitation |
NCT04196933 -
Analysis of Vestibular Compensation Following Clinical Intervention for Vestibular Schwannoma
|
N/A | |
Completed |
NCT05427097 -
Thermal Energy in the Treatment of Cervicogenic Dizziness
|
N/A | |
Completed |
NCT02733549 -
Is The Sudden Onset of Dizziness A Symptom of Acute Liver Dysfunction?
|
N/A | |
Completed |
NCT05812209 -
Stellate Ganglion Block to Treat Long COVID 19 Case Series
|
||
Not yet recruiting |
NCT03973658 -
Dizziness Among First Time Users of Hearing Aids
|
||
Completed |
NCT03182868 -
Vestibular Testing: Consistency and Effects Over Time
|
N/A | |
Completed |
NCT02938221 -
Telemedical Examination of a Three-Component Oculomotor Testing Battery
|
N/A | |
Active, not recruiting |
NCT02655575 -
Assessment and Treatment of Patients With Long-term Dizziness in Primary Care
|
N/A | |
Completed |
NCT02772042 -
Traction Manipulation of Upper Cervical Spine on Cervicogenic Dizziness
|
N/A | |
Completed |
NCT00732797 -
A Trial of Booklet Based Self Management of Dizziness
|
N/A | |
Not yet recruiting |
NCT06010550 -
Validating a Clinical Decision Support Tool for Stratifying Stroke Risk for Dizziness/Vertigo
|
||
Recruiting |
NCT03618199 -
Efficacy of a Transcranial Vibrating System for Minimizing Dizziness During Caloric Testing
|
N/A | |
Completed |
NCT03330262 -
Head-Mounted Vibrotactile Prosthesis for Patients With Chronic Postural Instability
|
N/A | |
Completed |
NCT05157399 -
Quantification of the Effect of the OtoBand on Objective Measures of Vertigo and Dizziness
|
N/A | |
Completed |
NCT02344446 -
Physical Therapy Intervention for Extended Physical Symptoms After a Sports-related Concussion
|
N/A | |
Withdrawn |
NCT00732108 -
Is Topiramate Effective in Treating Dizziness in Patient's With Migraine-Associated Dizziness
|
N/A | |
Active, not recruiting |
NCT05122663 -
Emergency Department Vestibular Rehabilitation Therapy for Dizziness and Vertigo
|
||
Recruiting |
NCT05634902 -
Implementation of Evidence-Based Practice for Dizziness
|
N/A | |
Completed |
NCT02640599 -
Stationary Bike Study
|
N/A | |
Enrolling by invitation |
NCT05990023 -
The Effect of Computerized Vestibular Function Assessment and Training System Combined With Cognitive/Motor Dual-task
|
N/A |