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

NCT05859815 | Terminated

• 1 other identifier: STUDY00006666
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 2

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.

Conditions

Brain Concussion; Mild Traumatic Brain Injury

Keywords

Mechanical Diagnosis and Therapy; Directional Preference; Repeated Movements

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Post-Concussion Symptom Scale

  Through study completion, up to 1 year.

• Neck Disability Index

  Through study completion, up to 1 year.

• Dizziness Handicap Inventory

  Through study completion, up to 1 year.

Other Outcomes (2)

• Return to sport/activity

  Up to 1 year

• Number of treatments

  Up to 1 year

Study Arms (2)

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

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

Interventions

Physical Therapy BEHAVIORAL

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; Directional preference responder

Eligibility Criteria

• Age: 13 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• State University of New York at Buffalo: lead

Study Sites (2)

Goodlife Physical Therapy

Orland Park, Illinois, 60467, United States

Location

Summit Healthplex Physcial Therapy/Niagara Falls Memorial Medical Center

Niagara Falls, New York, 14304, United States

Location

MeSH Terms

Conditions

Brain Concussion

Interventions

Physical Therapy Modalities

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

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Michael R Brown, DPT, PhD

  University at Buffalo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: March 22, 2023
• First Posted: May 16, 2023
• Study Start: July 20, 2023
• Primary Completion: February 10, 2026
• Study Completion: February 10, 2026
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)