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Home-Based therapy aims to rebuild lives after brain injury

NCT ID NCT05117619

Disease control Sponsor: Villanova University Source: ClinicalTrials.gov ↗

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests a 4-month in-home rehabilitation program called HOME for Us for people who have had a traumatic brain injury (TBI) at least one year ago and their family caregivers. The program involves eight sessions with an occupational therapist, focusing on adapting the home environment and teaching strategies to manage chronic TBI symptoms. Researchers want to see if it improves community reintegration, quality of life, and symptom management for the person with TBI, while also reducing caregiver burden and depression.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
HOME for Us program (in-home occupational therapy sessions)
What this could lead to
If it works, this program could help people with TBI and their families manage symptoms better and improve daily life at home.
What could go wrong
This is a behavioral intervention study, so results depend on participant engagement and may not apply to all TBI cases. The program is intensive and may not be widely available.

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

281 people

The number who actually took part.

Started

Dec 2021

Expected to finish

Mar 2027

An estimate. End dates often move.

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

18 years and older

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: TBI Participant: * English speaking * 18 years or older * Most recent TBI at least 1 year ago * Has participating family member living with person with TBI * Willing/able to provide informed consent * Meets criteria for mild, moderate, or severe TBI * Acknowledges TBI-related symptoms at screening Family Member * Family member, partner, or significant other * Living with person with TBI * 18 years or older * Actively involved in the person's life * English speaking * Willing/able to provide informed consent Exclusion Criteria: TBI Participant: * Dementia based on (a) physician diagnosis of dementia and/or (b) participant's difficulty in comprehending interview questions * History of recent violence * Aphasia * Recent psychosis Family Member * None

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Conditions

The condition(s) this trial relates to.

Brain Injuries, Traumatic traumatic brain injury

As listed by the trial registrant

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

Brain injuries, traumatic

Contacts and locations

Locations

  • Villanova University

    Villanova, Pennsylvania, 19085, United States

More trials for these conditions

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