Effectiveness of Early Physical Therapy Intervention for Patients With Dizziness After a Sports-Related Concussion
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|ClinicalTrials.gov Identifier: NCT02299128|
Recruitment Status : Completed
First Posted : November 24, 2014
Last Update Posted : February 25, 2016
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.
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.
|Condition or disease||Intervention/treatment||Phase|
|Brain Concussion Dizziness||Other: Physical Therapy Treatment||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||41 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|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|
|Study Start Date :||September 2014|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||January 2016|
Sham Comparator: Minimally Therapeutic Treatment
Non-differential, prescriptive protocol of physical therapy treatment with minimal to no therapeutic benefit.
Other: Physical Therapy Treatment
Experimental: Skilled Treatment
Differential treatment based on the results from the assessment. Physical Therapy treatment in this arm will be pragmatically designed and modified by the treating therapist. Treatments will include manual therapy to the cervical spine, neuromotor retraining (position sense and movement sense), habituation and adaptation exercises.
Other: Physical Therapy Treatment
- Symptom recovery as measured by the Post Concussion Symptom (PCS) Score [ Time Frame: Final visit (by the end of 4 weeks of treatment) ]7 point Likert scale (0 - 6) rating the severity of 22 symptoms commonly associated with concussion.
- Return to Play (RTP) [ Time Frame: Final visit (by the end of 4 weeks of treatment) ]Five stage progressive increase in physical activity ranging from minimal exertion to full contact in a game
- Change Score of Functional Gait Assessment [ Time Frame: Initial assessment and final visit (by the end of 4 weeks of treatment) ]Used to test balance with gait activities.
- Change score of Vertigo Symptom Scale - Short Form [ Time Frame: Initial assessment and final visit (by the end of 4 weeks of treatment) ]Frequency of various types and durations of sensation of dizziness
- Global Response to Treatment [ Time Frame: Final Visit (by the end of 4 weeks of treatment) ]Global perception of change in physical symptoms from the beginning of treatment to the end
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02299128
|United States, Ohio|
|North Canton, Ohio, United States, 44720|
|Principal Investigator:||Jennifer C Reneker, MSPT||Walsh University|