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Physical Therapy Intervention for Extended Physical Symptoms After a Sports-related Concussion

Primary Purpose

Concussion, Dizziness

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Skilled Therapy
Sponsored by
Walsh University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Concussion focused on measuring physical therapy intervention

Eligibility Criteria

10 Years - 23 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients will be recruited from the ongoing Randomized Clinical Trial (Walsh University HSR 14-20) that are not returned to play and/or are not asymptomatic at the completion of their involvement in this research protocol. Based on the timeframe for their participation in the aforementioned study, these athletes will be 30 - 50 days post-concussion. At their final visit for the RCT, patients with one of the following criteria will be invited to participate in this research study:

    1. Lack of release for Return to Play
    2. Continuation of physical symptoms (headache, nausea, vomiting, balance problems, dizziness, light or noise sensitivity, numbness and/or vision problems) as recorded on the Post-Concussion Symptom Scale

Exclusion Criteria:

  • Any one who is not enrolled in the aforementioned RCT

Sites / Locations

  • Walsh University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Skilled Therapy

Arm Description

Differential physical therapy treatment, based on assessment results, with follow-up visits for PT treatment 1 - 2 times per week until patient achieves at least 1 primary outcome. They will pragmatically design an individualized and progressive treatment plan, including manual therapy (manipulation and/or mobilization), neuromotor control strategies, and vestibular rehabilitation techniques, depending on the findings at assessment and patient response. Therapists can also tailor education regarding mental and physical rest according to specific parameters provided by the treating physician. Patients may also be prescribed a home exercise program and exercise education. The precise treatment strategies will be recorded.

Outcomes

Primary Outcome Measures

Symptomatic Recovery
Using the Post-Concussion Symptom Scale, self-reported symptomatic presentation will be tracked at each visit
Return to Play
The treating physician will determine when return to play should be initiated.

Secondary Outcome Measures

Full Information

First Posted
January 13, 2015
Last Updated
February 24, 2016
Sponsor
Walsh University
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1. Study Identification

Unique Protocol Identification Number
NCT02344446
Brief Title
Physical Therapy Intervention for Extended Physical Symptoms After a Sports-related Concussion
Official Title
Physical Therapy Intervention for Extended Physical Symptoms After a Sports-related Concussion
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Walsh University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to investigate if skilled physical therapy treatment for dizziness after sports-related concussion, delivered after greater than 30 days post-concussion is effective to remediate physical symptoms. This will be the first study that explores differential PT treatment for dizziness in concussed athletes who have physical symptoms 30+ days after concussion. The findings of this important research have great potential to influence clinical practice and place increased emphasis on and acceptance of manual skills and neuromotor training in the treatment of concussed patients with dizziness.
Detailed Description
Patients will be recruited from the ongoing Randomized Clinical Trial (Walsh University HSR 14-20) that are not returned to play and/or are not asymptomatic at the completion of their involvement in this research protocol. Based on the timeframe for their participation in the aforementioned study, these athletes will be 30 - 50 days post-concussion. At their final visit for the RCT, patients with one of the following criteria will be invited to participate in this research study: Lack of release for Return to Play Continuation of physical symptoms (headache, nausea, vomiting, balance problems, dizziness, light or noise sensitivity, numbness and/or vision problems) as recorded on the Post-Concussion Symptom Scale. Desired sample size: 15 participants. Skilled treatment: patients will be scheduled for a physical therapy assessment. The PTs will use a prescriptive approach to the assessment of the central nervous system, the cervical spine, and the vestibular system to determine the relative involvement of each system and dysfunction contributing to the patient's physical complaints. This assessment will include the outcome measures that will be obtained pre and post-treatment (Vertigo Symptom Scale (VSS) and the Functional Gait Assessment (FGA). Once the assessment is completed, the PT will initiate treatment, with follow-up visits for PT treatment 1 - 2 times per week. They will pragmatically design an individualized and progressive treatment plan, including manual therapy (manipulation and/or mobilization), neuromotor control strategies, and vestibular rehabilitation techniques, depending on the findings at assessment and patient response. Therapists can also tailor education regarding mental and physical rest according to specific parameters provided by the treating physician. Patients may also be prescribed a home exercise program and exercise education. The precise treatment strategies will be recorded. At each PT visit, symptomatic recovery will be tracked using the PCS.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Concussion, Dizziness
Keywords
physical therapy intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Skilled Therapy
Arm Type
Experimental
Arm Description
Differential physical therapy treatment, based on assessment results, with follow-up visits for PT treatment 1 - 2 times per week until patient achieves at least 1 primary outcome. They will pragmatically design an individualized and progressive treatment plan, including manual therapy (manipulation and/or mobilization), neuromotor control strategies, and vestibular rehabilitation techniques, depending on the findings at assessment and patient response. Therapists can also tailor education regarding mental and physical rest according to specific parameters provided by the treating physician. Patients may also be prescribed a home exercise program and exercise education. The precise treatment strategies will be recorded.
Intervention Type
Other
Intervention Name(s)
Skilled Therapy
Intervention Description
Active physical therapy treatment
Primary Outcome Measure Information:
Title
Symptomatic Recovery
Description
Using the Post-Concussion Symptom Scale, self-reported symptomatic presentation will be tracked at each visit
Time Frame
Within 6 months of enrollment
Title
Return to Play
Description
The treating physician will determine when return to play should be initiated.
Time Frame
Within 6 months of enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
23 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients will be recruited from the ongoing Randomized Clinical Trial (Walsh University HSR 14-20) that are not returned to play and/or are not asymptomatic at the completion of their involvement in this research protocol. Based on the timeframe for their participation in the aforementioned study, these athletes will be 30 - 50 days post-concussion. At their final visit for the RCT, patients with one of the following criteria will be invited to participate in this research study: Lack of release for Return to Play Continuation of physical symptoms (headache, nausea, vomiting, balance problems, dizziness, light or noise sensitivity, numbness and/or vision problems) as recorded on the Post-Concussion Symptom Scale Exclusion Criteria: Any one who is not enrolled in the aforementioned RCT
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer C Reneker, MSPT
Organizational Affiliation
Walsh Unviersity
Official's Role
Principal Investigator
Facility Information:
Facility Name
Walsh University
City
North Canton
State/Province
Ohio
ZIP/Postal Code
44720
Country
United States

12. IPD Sharing Statement

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Physical Therapy Intervention for Extended Physical Symptoms After a Sports-related Concussion

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