Brain ConcussionPhase 1NCT05594225
Tele-Rehabilitation to Improve Mild Traumatic Brain Injury Recovery and Reduce Subsequent Injury Risk
A Phase 1 study testing Virtual Neuromuscular/Dual-Task Training in people with Brain Concussion, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The goal of this clinical trial is to examine the feasibility, utility, and efficacy of a smartphone-based assessment battery and remotely administered virtual Neuromuscular/Dual-Task (vNDT) intervention among healthy U.S. military service members and physically active young adults with a recent concussion. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Brain Concussion
- What is being tested?
- Virtual Neuromuscular/Dual-Task Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Aug 2023to 30 Sep 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18-40 years of age at the time of enrollment
- Mild TBI or concussion diagnosis by a physician
- Confirmed MTBI diagnosis via VA/DOD guidelines at time of enrollment
- Participation in regular physical activity prior to injury (confirmed via the Global Physical Activity Questionnaire [GPAQ]) (Cleland et al., 2014; Keating et al., 2019)
- Access to a smartphone for app download
Who cannot join
- Moderate or severe TBI
- Pre-injury neurological disorder
- Abnormal brain imaging findings (if performed as a part of routine care)
- Previous TBI (mild/moderate/severe) <12 months prior to enrollment other than the current injury for which they are being seen
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Denver
Aurora, Colorado, 80045
About this study
The goal of this clinical trial is to examine the feasibility, utility, and efficacy of a smartphone-based assessment battery and remotely administered virtual Neuromuscular/Dual-Task (vNDT) intervention among healthy U.S. military service members and physically active young adults with a recent concussion.
Read the detailed description
Aim 1. Determine the baseline neuromuscular/dual-task performance characteristics among a sample of active-duty military service members compared to physically active young adult civilians.
The investigators hypothesize that active-duty military service members will have similar baseline gait and dual-task abilities as civilians, demonstrating translation potential between populations.
The investigators also hypothesize that baseline gait and dual-task abilities will be influenced by history of prior mTBI injuries among military Service Members.
Aim 2. Examine the efficacy of a smartphone-based vNDTT intervention to reduce musculoskeletal injury and improve neuromuscular/dual-task performance after a recent mTBI.
The investigators hypothesize that those randomized to the intervention within three weeks of mTBI will have a lower risk of MSK injury in the 3-month period following mTBI, relative to standard-of-care.
The investigators also hypothesize that those randomized to the intervention within three weeks of mTBI will have better post-intervention gait and dual-task performance than those assigned to standard-of-care, despite similar baseline performance.
- Conditions
- Brain Concussion
- Being tested
- Virtual Neuromuscular/Dual-Task Training
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Neuromuscular/Dual-Task TrainingBehavioural
The vNDTT strategy incorporates lower body strength exercises with landing stabilization focus. Exercises will begin after the initial study visit and last for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Neuromuscular/Dual-Task Training | Experimental | The vNDTT strategy incorporates lower body strength exercises with landing stabilization focus. Exercises will begin after the initial study visit and last for 8 weeks. Receives: Behavioral: Virtual Neuromuscular/Dual-Task Training |
| Standard-of-care | No intervention | Participants will be provided routine instructions related to physical activity and rehabilitation exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Injury rate
Acute musculoskeletal injury rate
Measured: 3 months after mTBI
Secondary outcomes (6)
Intervention adherence
Virtually logging a training session on the smartphone application (# of sessions logged/planned sessions
Measured: Upon enrollment and for the subsequent 8 weeks
Quality of Life Domains: Mobility, Depressive Symptoms, Fatigue, Pain Interference
Patient-Reported Outcomes Measurement Information System (PROMIS) global questionnaire
Measured: During the initial (post-injury) evaluation and again at the follow-up (8 weeks after initial evaluation) test
Sleep quality
Participants will complete the Pittsburgh Sleep Quality Inventory
Measured: During the initial (post-injury) evaluation and again at the follow-up (8 weeks after initial evaluation) test
Dizziness
Participants will complete the Dizziness Handicap Inventory
Measured: During the initial (post-injury) evaluation and again at the follow-up (8 weeks after initial evaluation) test
Anxiety
Participants will complete the General Anxiety Disorder - 7 scale
Measured: During the initial (post-injury) evaluation and again at the follow-up (8 weeks after initial evaluation) test
Single/dual-task standing and gait
Participants will perform walking trials under single and dual-task conditions
Measured: During the initial (post-injury) evaluation and again at the follow-up (8 weeks after initial evaluation) test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2022
- Study start23 Aug 2023
- Primary completion30 Jun 2025
- Study completion30 Sep 2026 (estimated)
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 University of Colorado, DenverThe 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will enroll and undergo initial testing within three weeks of mTBI, be randomized to an 8-week vNDTT or standard-of-care intervention, return for post-intervention testing, and be monitored for subsequent MSK injuries in the three months after mTBI
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Binghamton University
- Responsible party
- Sponsor
- Investigators
- David R Howell, PhD, Principal investigator, University of Colorado School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05594225
- Sponsor's protocol ID
- 22-1352
- Status last verified
- May 2026
- First submitted
- 21 Oct 2022
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Unidentified/blinded IPD data may be made available upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tele-Rehabilitation to Improve Mild Traumatic Brain Injury Recovery and Reduce Subsequent Injury Risk
- ClinicalTrials.gov ID
- NCT05594225
- Acronym / sponsor ID
- 22-1352
- Conditions
- Brain Concussion
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Binghamton University
- Study start
- 23 Aug 2023 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 26 Oct 2022 (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 goal of this clinical trial is to examine the feasibility, utility, and efficacy of a smartphone-based assessment battery and remotely administered virtual Neuromuscular/Dual-Task (vNDT) intervention among healthy U.S. military service members and physically active young adults with a recent concussion.
Detailed description
Aim 1. Determine the baseline neuromuscular/dual-task performance characteristics among a sample of active-duty military service members compared to physically active young adult civilians.
The investigators hypothesize that active-duty military service members will have similar baseline gait and dual-task abilities as civilians, demonstrating translation potential between populations.
The investigators also hypothesize that baseline gait and dual-task abilities will be influenced by history of prior mTBI injuries among military Service Members.
Aim 2. Examine the efficacy of a smartphone-based vNDTT intervention to reduce musculoskeletal injury and improve neuromuscular/dual-task performance after a recent mTBI.
The investigators hypothesize that those randomized to the intervention within three weeks of mTBI will have a lower risk of MSK injury in the 3-month period following mTBI, relative to standard-of-care.
The investigators also hypothesize that those randomized to the intervention within three weeks of mTBI will have better post-intervention gait and dual-task performance than those assigned to standard-of-care, despite similar baseline performance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will enroll and undergo initial testing within three weeks of mTBI, be randomized to an 8-week vNDTT or standard-of-care intervention, return for post-intervention testing, and be monitored for subsequent MSK injuries in the three months after mTBI
| Arm | Type | Receives |
|---|---|---|
| Virtual Neuromuscular/Dual-Task Training | Experimental | Behavioral: Virtual Neuromuscular/Dual-Task TrainingThe vNDTT strategy incorporates lower body strength exercises with landing stabilization focus. Exercises will begin after the initial study visit and last for 8 weeks. |
| Standard-of-care | No intervention | –Participants will be provided routine instructions related to physical activity and rehabilitation exercises |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 18-40 years of age at the time of enrollment
- Mild TBI or concussion diagnosis by a physician
- Confirmed MTBI diagnosis via VA/DOD guidelines at time of enrollment
- Participation in regular physical activity prior to injury (confirmed via the Global Physical Activity Questionnaire [GPAQ]) (Cleland et al., 2014; Keating et al., 2019)
- Access to a smartphone for app download
Key exclusion criteria (4 listed)
- Moderate or severe TBI
- Pre-injury neurological disorder
- Abnormal brain imaging findings (if performed as a part of routine care)
- Previous TBI (mild/moderate/severe) <12 months prior to enrollment other than the current injury for which they are being seen
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 |
|---|---|---|
| Virtual Neuromuscular/Dual-Task TrainingThe vNDTT strategy incorporates lower body strength exercises with landing stabilization focus. Exercises will begin after the initial study visit and last for 8 weeks. | Behavioural | Virtual Neuromuscular/Dual-Task Training |
Primary outcome
Injury rate
Time frame: 3 months after mTBI
Acute musculoskeletal injury rate
6 secondary outcomes
Intervention adherence
Time frame: Upon enrollment and for the subsequent 8 weeks
Quality of Life Domains: Mobility, Depressive Symptoms, Fatigue, Pain Interference
Time frame: During the initial (post-injury) evaluation and again at the follow-up (8 weeks after initial evaluation) test
Sleep quality
Time frame: During the initial (post-injury) evaluation and again at the follow-up (8 weeks after initial evaluation) test
Dizziness
Time frame: During the initial (post-injury) evaluation and again at the follow-up (8 weeks after initial evaluation) test
Anxiety
Time frame: During the initial (post-injury) evaluation and again at the follow-up (8 weeks after initial evaluation) test
Single/dual-task standing and gait
Time frame: During the initial (post-injury) evaluation and again at the follow-up (8 weeks after initial evaluation) test
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Individual participant dataSharing planned: Undecided. Unidentified/blinded IPD data may be made available upon reasonable request.
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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.
David R Howell, PhD principal investigator
University of Colorado School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Virtual Neuromuscular/Dual-Task Training in people with Brain Concussion, run by University of Colorado, Denver at 1 site 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 5 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Injury rate (time frame: 3 months after mTBI). 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 8 May 2026; AzTrials last refreshed its copy on 8 Nov 2026.