Effectiveness of Early Physical Therapy Intervention for Patients With Dizziness After a Sports-Related Concussion

NCT02299128 | Completed

• 1 other identifier: 14-20
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Concussion; Dizziness

Outcome Measures

Primary Outcomes (2)

• Symptom recovery as measured by the Post Concussion Symptom (PCS) Score

  7 point Likert scale (0 - 6) rating the severity of 22 symptoms commonly associated with concussion.

  Final visit (by the end of 4 weeks of treatment)

• Return to Play (RTP)

  Five stage progressive increase in physical activity ranging from minimal exertion to full contact in a game

  Final visit (by the end of 4 weeks of treatment)

Secondary Outcomes (3)

• Change Score of Functional Gait Assessment

  Initial assessment and final visit (by the end of 4 weeks of treatment)

• Change score of Vertigo Symptom Scale - Short Form

  Initial assessment and final visit (by the end of 4 weeks of treatment)

• Global Response to Treatment

  Final Visit (by the end of 4 weeks of treatment)

Study Arms (2)

Minimally Therapeutic Treatment

SHAM COMPARATOR

Non-differential, prescriptive protocol of physical therapy treatment with minimal to no therapeutic benefit.

Other: Physical Therapy Treatment

Skilled Treatment

EXPERIMENTAL

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

Interventions

Physical Therapy Treatment OTHER

Also known as: Vestibular rehabilitation, Manual Therapy, Neuromotor training

Minimally Therapeutic Treatment; Skilled Treatment

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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Walsh University: lead
• Children's Hospital Medical Center of Akron: collaborator
• Kent State University: collaborator
• American Academy of Orthopaedic Manual Physical Therapists: collaborator
• Ohio Physical Therapy Association: collaborator

Study Sites (1)

Walsh University

North Canton, Ohio, 44720, United States

Location

MeSH Terms

Conditions

Brain Concussion; Dizziness

Interventions

Physical Therapy Modalities; Musculoskeletal Manipulations

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

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation; Complementary Therapies

Study Officials

• Jennifer C Reneker, MSPT

  Walsh University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 17, 2014
• First Posted: November 24, 2014
• Study Start: September 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: January 1, 2016
• Last Updated: February 25, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)