The Role of Mechanical Diagnosis and Therapy in the Management of Concussion

The Role of Mechanical Diagnosis and Therapy in the Classification and Management of Concussion

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.

Study Overview

• Status: Terminated
• Conditions: Brain Concussion; Mild Traumatic Brain Injury
• Intervention / Treatment: Behavioral: Physical Therapy

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.

• Study Type: Observational
• Enrollment (Actual): 13

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Orland Park, Illinois, United States, 60467
      • Goodlife Physical Therapy
  • New York
    • Niagara Falls, New York, United States, 14304
      • Summit Healthplex Physcial Therapy/Niagara Falls Memorial Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Directional preference responder; This group is comprised of participants who responded to repeated movements in a direction (e.g., neck flexion) that significantly improved their symptoms and/or their ability to move their head/neck.	Behavioral: Physical Therapy; As part of their normal care, participants will receive any combination of the following interventions to address their specific needs identified during the initial evaluation: cervical spine repeated movements (active range of motion), cervical spine stabilization exercise, aerobic exercise, motor control training, oculomotor/vestibular rehabilitation, stretching, soft-tissue mobilization, joint mobilization, and postural re-education activities.
Directional preference non-responder; This group is comprised of participants who did not respond to repeated movements in any specific direction that significantly improved their symptoms and/or their ability to move their head/neck.	Behavioral: Physical Therapy; As part of their normal care, participants will receive any combination of the following interventions to address their specific needs identified during the initial evaluation: cervical spine repeated movements (active range of motion), cervical spine stabilization exercise, aerobic exercise, motor control training, oculomotor/vestibular rehabilitation, stretching, soft-tissue mobilization, joint mobilization, and postural re-education activities.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Directional preference classification	Outcome represents the patient's directional preference at the time of discharge from care. Patients will be classified as directional preference responders or non-responders.	Through study completion, up to 1 year.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-Concussion Symptom Scale	The PCSS is a patient self-reported outcome measure that measures the amount of interference associated with a concussion across four domains: physical, cognitive, emotion, and sleep. The measure consists of 22 questions that relate to post-concussive symptoms. The measure uses a 7-point Likert scale, where 0 = no symptoms and 6 = severe symptoms. The greatest possible score is 132 and the lowest score is 0. Higher scores indicate higher severity of post-concussive symptoms.	Through study completion, up to 1 year.
Neck Disability Index	The NDI is a patient self-reported outcome measure that measures the amounts of pain interference and self-reported disability related to neck pain. The measure consists of ten questions in the following domains: pain intensity, personal care, lifting, reading, sleeping, work, recreation, reading, concentration, and headaches. Each item is rated on a 0 to 5 scale, where 0 = no disability and 5 = complete disability. The highest possible raw score equals 50 points, the lowest possible score equals 0. The raw scores can also be converted to a percentage from 0 to 100%. Higher scores indicate higher levels of self-reported disability.	Through study completion, up to 1 year.
Dizziness Handicap Inventory	The DHI is a patient self-reported outcome measure that measures the impact of dizziness on daily life. The DHI consists of 25 items measuring the impact of dizziness across three domains: functional (9 questions,= 36 points), emotional (9 questions = 36 points), and physical (7 questions = 28 points). Each item is rated on a 3 point scale (yes = 4, sometimes = 2, no = 0). Item scores are summed, with a possible total of 100 points. The best possible score is a 0. Higher scores indicate greater perceived handicap due to dizziness.	Through study completion, up to 1 year.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Return to sport/activity	This outcome represents the number of days it takes a patient to return to their prior level of participation in sport/activity	Up to 1 year
Number of treatments	This outcome represents the number of physical therapy visits they completed before being discharged by the physician or physical therapist.	Up to 1 year

Collaborators and Investigators

• Sponsor: State University of New York at Buffalo
• Investigators: Principal Investigator: Michael R Brown, DPT, PhD, University at Buffalo

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2023
• Primary Completion (Actual): February 10, 2026
• Study Completion (Actual): February 10, 2026

Study Registration Dates

• First Submitted: March 22, 2023
• First Submitted That Met QC Criteria: May 5, 2023
• First Posted (Actual): May 16, 2023

Study Record Updates

• Last Update Posted (Actual): February 13, 2026
• Last Update Submitted That Met QC Criteria: February 11, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Mechanical Diagnosis and Therapy; Directional Preference; Repeated Movements
• Additional Relevant MeSH Terms: Brain Injuries, Traumatic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Injuries; Brain Concussion; Therapeutics; Rehabilitation; Physical Therapy Modalities
• Other Study ID Numbers: STUDY00006666

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No