Clinical trial NCT05859815: The Role of Mechanical Diagnosis and Therapy in the Management of Concussion
Official title: The Role of Mechanical Diagnosis and Therapy in the Classification and Management of Concussion
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Brain Concussion
Mild Traumatic Brain Injury
Keywords: Mechanical Diagnosis and Therapy
Directional Preference
Repeated Movements
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
First posted: 2023-05-16
Enrollment: 100
Sex: ALL
Minimum age (years): 13
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of patients who have been diagnosed with a concussion and referred for outpatient physical therapy services.

Brief summary: The purpose of this study is to examine the role of a Mechanical Diagnosis and Therapy (MDT) examination in identifying participants diagnosed with concussion who display a directional preference compared to who don't display a directional preference.

Detailed description: Directional preference describes the clinical phenomenon where a specific direction of repeated movement and / or sustained position results in a clinically relevant improvement in symptoms. This improvement is usually accompanied by an improvement in function or mechanics or both. Its presence and relevance is determined over 2-3 visits. This study aims to identify the proportion of participants with concussion who present with a directional preference during the course of physical therapy. A secondary aim of this study is to investigate whether directional preference is associated with the eventual patient related outcomes following care.

Eligibility criteria: Inclusion Criteria:

* Age = 13 - 65
* Complaints of neck pain, headache, or dizziness associated with a diagnosis of concussion or mild TBI
* Ability to read/write English
* Referral from physician

Exclusion Criteria:

* Age less than 13 or greater than 65
* Cause of symptoms is result of a work-related accident or motor vehicle accident
* Receiving concurrent treatment from a chiropractor or massage therapist
* Glasgow Coma Scale less than 12
* Lesion on head CT/MRI
* Focal neurological deficits associated with serious spinal pathology (fracture, infection, tumor, vertebrobasilar insufficiency)
* Inability to or unwilling to exercise as part of usual PT care
* Unable to read/write English
* History of osteopenia/osteoporosis or cancer

Primary outcomes:
measure: Directional preference classification
timeFrame: Through study completion, up to 1 year.
Secondary outcomes:
measure: Post-Concussion Symptom Scale
timeFrame: Through study completion, up to 1 year.
measure: Neck Disability Index
timeFrame: Through study completion, up to 1 year.
measure: Dizziness Handicap Inventory
timeFrame: Through study completion, up to 1 year.
Other outcomes:
measure: Return to sport/activity
timeFrame: Up to 1 year
measure: Number of treatments
timeFrame: Up to 1 year
Locations:
city: Orland Park
country: United States
facility: Goodlife Physical Therapy
state: Illinois
city: Niagara Falls
country: United States
facility: Summit Healthplex Physcial Therapy/Niagara Falls Memorial Medical Center
state: New York
Study officials:
affiliation: University at Buffalo
name: Michael R Brown, DPT, PhD
role: PRINCIPAL_INVESTIGATOR
References: