Brain ConcussionNCT05859815
The Role of Mechanical Diagnosis and Therapy in the Management of Concussion
An observational study of Brain Concussion and Mild Traumatic Brain Injury, run by State University of New York at Buffalo at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 65 years
- Conditions the study is for
- Brain Concussion, Mild Traumatic Brain Injury
- What is being tested?
- Physical Therapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 13 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Jul 2023to 10 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population will consist of patients who have been diagnosed with a concussion and referred for outpatient physical therapy services.
Who may be able to join
- 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
Who cannot join
- 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)
Show all 9Show fewer
- Inability to or unwilling to exercise as part of usual PT care
- Unable to read/write English
- History of osteopenia/osteoporosis or cancer
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Summit Healthplex Physcial Therapy/Niagara Falls Memorial Medical Center
Niagara Falls, New York, 14304
Goodlife Physical Therapy
Orland Park, Illinois, 60467
About this study
Official title: 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.
Read the 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.
- Conditions
- Brain Concussion, Mild Traumatic Brain Injury
- Being tested
- Physical Therapy
- Keywords
- Mechanical Diagnosis and Therapy, Directional Preference, Repeated Movements
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, up to 1 year.
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Through study completion, up to 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study start20 Jul 2023
- Primary completion10 Feb 2026
- Study completion10 Feb 2026
Why it stopped: Study was terminated due to lack of referral sources and limited participant enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain ConcussionStudies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Brown, State University of New York at Buffalo
- Investigators
- Michael R Brown, DPT, PhD, Principal investigator, University at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05859815
- Sponsor's protocol ID
- STUDY00006666
- Status last verified
- Feb 2026
- First submitted
- 22 Mar 2023
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Mechanical Diagnosis and Therapy in the Classification and Management of Concussion
- ClinicalTrials.gov ID
- NCT05859815
- Acronym / sponsor ID
- STUDY00006666
- Conditions
- Brain Concussion, Mild Traumatic Brain Injury
- Keywords
- Mechanical Diagnosis and Therapy, Directional Preference, Repeated Movements
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study was terminated due to lack of referral sources and limited participant enrollment.
- Enrolment
- 13 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- 20 Jul 2023 (actual)
- Primary completion
- 10 Feb 2026 (actual)
- Study completion
- 10 Feb 2026 (actual)
- First posted
- 16 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Directional preference responder | – | Behavioral: Physical TherapyThis 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. |
| Directional preference non-responder | – | Behavioral: Physical TherapyThis 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. |
Who may qualify
- Ages
- 13 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will consist of patients who have been diagnosed with a concussion and referred for outpatient physical therapy services.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical TherapyAs 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. | Behavioural | Directional preference non-responder, Directional preference responder |
Primary outcome
Directional preference classification
Time frame: Through study completion, up to 1 year.
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.
3 secondary outcomes
Post-Concussion Symptom Scale
Time frame: Through study completion, up to 1 year.
Neck Disability Index
Time frame: Through study completion, up to 1 year.
Dizziness Handicap Inventory
Time frame: Through study completion, up to 1 year.
Results and safety
The study was stopped early (reason given: Study was terminated due to lack of referral sources and limited participant enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael R Brown, DPT, PhD principal investigator
University at Buffalo
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Concussion and Mild Traumatic Brain Injury, run by State University of New York at Buffalo at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study was terminated due to lack of referral sources and limited participant enrollment.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Directional preference classification (time frame: Through study completion, up to 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.