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Brain injury survivors walk more with simple nudges, study finds

NCT ID NCT06222502

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether planning, reminders, and small rewards can help older adults who had a mild or moderate traumatic brain injury (TBI) walk more. 57 participants wore a Fitbit and received weekly calls for 12 weeks. The goal was to see if these simple tools could increase walking and improve brain health.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

57 people

The number who actually took part.

Started

Apr 2024

Finished

Dec 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: • Suffered a mild or moderate traumatic brain injury within 3 months to 15 years prior to recruitment. \* TBI history will be assessed using the validated OSU TBI history questionnaire (Attachment 1). TBI severity will be defined as loss of consciousness of 0-30 minutes (mild) or \>30 minutes and \<24 hours (moderate). If no loss of consciousness was reported but post-traumatic amnesia was reported, then this is considered a mild TBI. If clinical reports from the time of injury are available and Glasgow Coma Scale scores are available, then 13-15 is considered mild and 9-12 moderate. A clinical neurologist will review the de-identified OSU TBI forms for accuracy and confirm TBI severity. * Men and women of all ethnicities/races and socio-economic status. * 40-80 years. * Signed Informed consent. * Physically fit enough to undergo exercise as screened using the Physical Activity Readiness Questionnaire (PAR-Q) and the cardiovascular section of the Health History \& Demographics Questionnaire. An affirmative response (i.e., \"yes\") to any single item regarding an individual's health status is grounds for the necessary medical clearance before enrollment. * Normal or corrected-to-normal vision based on the minimal 20/20 standard in order to complete the cognitive tasks (below 20/20 vision). * Able to speak, read, and write English. * Ambulatory without pain or the assistance of walking devices. * Reliable means of transportation (if participating in Boston). * No diagnosis of a neurological disease. * No intracerebral brain bleeds. * Access to a mobile device, laptop or desktop computer with internet access and Bluetooth. Exclusion Criteria: * Diagnosis of a severe TBI (loss of consciousness \>24 hours, post-traumatic amnesia \> 7 days of a Glasgow Coma Scale of \<9) or the presentation of skull breach. * Prior diagnosis of cognitive or physical disability (severe asthma, epilepsy, chronic kidney disease, and dependence upon a wheelchair/walking aid). * Not fluent in English. * Undergoing any speech or physical therapy * Not medically cleared for exercise. * No history of vasovagal episodes (sudden drops in heart rate, poor perfusion, constant dizziness) * History of intracerebral brain bleeds or strokes. * Neurological condition (MS, Parkinson's, Dementia, MCI). * Current treatment for congestive heart failure, angina, uncontrolled arrhythmia, DVT or other cardiovascular events. * Myocardial infarction, coronary artery bypass grafting, angioplasty or other cardiac condition in the past year. * Regular use of an assisted walking device.

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Conditions

The condition(s) this trial relates to.

Brain Concussion Brain Injuries, Traumatic brain injury Motor Activity transient ischemic attack traumatic brain injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Northeastern University

    Boston, Massachusetts, 02115, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.