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

NCT ID: NCT05859815

Last Updated: 2025-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-20

Study Completion Date

2026-06-30

Brief Summary

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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

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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.

Conditions

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Brain Concussion Mild Traumatic Brain Injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Physical Therapy

Intervention Type 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

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.

Physical Therapy

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

13 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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State University of New York at Buffalo

OTHER

Sponsor Role lead

Responsible Party

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Michael Brown

Clinical Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael R Brown, DPT, PhD

Role: PRINCIPAL_INVESTIGATOR

University at Buffalo

Locations

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Goodlife Physical Therapy

Orland Park, Illinois, United States

Site Status RECRUITING

Summit Healthplex Physcial Therapy/Niagara Falls Memorial Medical Center

Niagara Falls, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Michael R Brown, DPT, PhD

Role: CONTACT

716-829-6801

Facility Contacts

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Mickey Shah, DPT

Role: primary

708-966-4386

Margaux Lojacano, DPT

Role: primary

716-998-7947

Other Identifiers

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STUDY00006666

Identifier Type: -

Identifier Source: org_study_id

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