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

NCT02344446 | Completed

• 1 other identifier: WalshU
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Concussion; Dizziness

Keywords

physical therapy intervention

Outcome Measures

Primary Outcomes (2)

• Symptomatic Recovery

  Using the Post-Concussion Symptom Scale, self-reported symptomatic presentation will be tracked at each visit

  Within 6 months of enrollment

• Return to Play

  The treating physician will determine when return to play should be initiated.

  Within 6 months of enrollment

Study Arms (1)

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.

Other: Skilled Therapy

Interventions

Skilled Therapy OTHER

Active physical therapy treatment

Skilled Therapy

Eligibility Criteria

• Age: 10 Years - 23 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Any one who is not enrolled in the aforementioned RCT

Sponsors & Collaborators

• Walsh University: lead

Study Sites (1)

Walsh University

North Canton, Ohio, 44720, United States

Location

MeSH Terms

Conditions

Brain Concussion; Dizziness

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating; Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jennifer C Reneker, MSPT

  Walsh Unviersity

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 13, 2015
• First Posted: January 26, 2015
• Study Start: November 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: December 1, 2015
• Last Updated: February 25, 2016

Record last verified: 2016-02

Locations

US (1)