ConcussionNCT02344446
Physical Therapy Intervention for Extended Physical Symptoms After a Sports-related Concussion
A study testing Skilled Therapy in people with Concussion and Dizziness, run by Walsh University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 23 years
- Conditions the study is for
- Concussion, Dizziness
- What is being tested?
- Skilled Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 23 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Any one who is not enrolled in the aforementioned RCT
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Concussion, Dizziness
- Being tested
- Skilled Therapy
- Keywords
- physical therapy intervention
- Medical subject headings
- Brain Concussion, Dizziness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skilled TherapyOther
Active physical therapy treatment
| Study group | Role | What they receive |
|---|---|---|
| Skilled Therapy | Experimental | 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. Receives: Other: Skilled Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptomatic Recovery
Using the Post-Concussion Symptom Scale, self-reported symptomatic presentation will be tracked at each visit
Measured: Within 6 months of enrollment
Return to Play
The treating physician will determine when return to play should be initiated.
Measured: Within 6 months of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2015 (estimated)
- Study startNov 2014
- Primary completionNov 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConcussionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Walsh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Reneker, Walsh University
- Investigators
- Jennifer C Reneker, MSPT, Principal investigator, Walsh Unviersity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02344446
- Sponsor's protocol ID
- WalshU
- Status last verified
- Feb 2016
- First submitted
- 13 Jan 2015
- Last updated
- 25 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Therapy Intervention for Extended Physical Symptoms After a Sports-related Concussion
- ClinicalTrials.gov ID
- NCT02344446
- Acronym / sponsor ID
- WalshU
- Conditions
- Concussion, Dizziness
- Keywords
- physical therapy intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Walsh UniversityUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 26 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Skilled Therapy | Experimental | Other: Skilled TherapyDifferential 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. |
Who may qualify
- Ages
- 10 to 23 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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:
Key exclusion criteria (1 listed)
- Any one who is not enrolled in the aforementioned RCT
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skilled TherapyActive physical therapy treatment | Other | Skilled Therapy |
Primary outcome
Symptomatic Recovery
Time frame: Within 6 months of enrollment
Using the Post-Concussion Symptom Scale, self-reported symptomatic presentation will be tracked at each visit
Return to Play
Time frame: Within 6 months of enrollment
The treating physician will determine when return to play should be initiated.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer C Reneker, MSPT principal investigator
Walsh Unviersity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skilled Therapy in people with Concussion and Dizziness, run by Walsh University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptomatic Recovery (time frame: Within 6 months of enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2016.