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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
Sponsor:
Collaborators:
Children's Hospital Medical Center of Akron
Kent State University
American Academy of Orthopaedic Manual Therapists
Ohio Physical Therapy Association
Information provided by (Responsible Party):
Jennifer Reneker, Walsh University

Brief Summary:

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.


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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Sham Comparator: Minimally Therapeutic Treatment
Non-differential, prescriptive protocol of physical therapy treatment with minimal to no therapeutic benefit.
Other: Physical Therapy Treatment
Other Names:
  • Vestibular rehabilitation
  • Manual Therapy
  • Neuromotor training

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
Other Names:
  • Vestibular rehabilitation
  • Manual Therapy
  • Neuromotor training




Primary Outcome Measures :
  1. 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.

  2. 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


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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



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Ages Eligible for Study:   10 Years to 23 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Locations
United States, Ohio
Walsh University
North Canton, Ohio, United States, 44720
Sponsors and Collaborators
Walsh University
Children's Hospital Medical Center of Akron
Kent State University
American Academy of Orthopaedic Manual Therapists
Ohio Physical Therapy Association
Investigators
Principal Investigator: Jennifer C Reneker, MSPT Walsh University

Responsible Party: Jennifer Reneker, Assistant Professor, Walsh University
ClinicalTrials.gov Identifier: NCT02299128     History of Changes
Other Study ID Numbers: 14-20
First Posted: November 24, 2014    Key Record Dates
Last Update Posted: February 25, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Vestibular Diseases
Dizziness
Vertigo
Brain Concussion
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Brain Injuries, Traumatic
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Head Injuries, Closed
Wounds and Injuries
Wounds, Nonpenetrating