An Early Phase 1 interventional study of Walking in Traumatic Brain Injury (TBI) Patients, sponsored by Kessler Foundation. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by Kessler Foundation · Early Phase 1, Interventional, and Treatment
Among 44 studies in Brain Injuries, Traumatic by Kessler Foundation — 14 open to participants now, 16 under way, none of them phase 3. Brain Injuries, Traumatic · Kessler Foundation.
Among the 44 studies in Brain Injuries, Traumatic by Kessler Foundation, this one is the 19th largest by planned enrollment of the 42 interventional ones that give a count, is the only one that started in 2026, is one of 2 in phase 1, reaches primary completion later than 10 of the 15 other live ones, and was the 44th registered.
1,721 studies on the registry are indexed under Brain Injuries, Traumatic; 447 are open to participants now.
Browse Brain Injuries, Traumatic studies →14 of the 44 studies in Brain Injuries, Traumatic by Kessler Foundation are open now, in 1 country. Recruiting first, the newest first:
Kessler Foundation · Sites in United States
Kessler Foundation · Sites in United States
Kessler Foundation · Sites in United States
Kessler Foundation · Sites in United States
Kessler Foundation · Sites in United States
By country, each count listing its studies:
Of the 281 Brain Injuries, Traumatic studies recruiting now, 120 (43%) set no upper age limit and 119 (42%) stop at 75 or younger; 40 take children under 18; 52 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
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44 studies; the count open now beside each. This study's row is marked.
First in 2003; this study’s year is marked. 1 started in 2026.
This study's planned enrollment of 40 is below the median of 52 across 1,088 interventional studies indexed under Brain Injuries, Traumatic.
Median enrollment 36 across the 42 interventional studies, 45 across the 2 observational. Of the 16 that completed or were terminated, 0 (0%) have results posted.
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Kessler Foundation is the lead sponsor of 175 studies on the registry; 61 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
3 of the studies in Brain Injuries, Traumatic by Kessler Foundation that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07733284Kessler FoundationHome-Based Walking for Thinking Skills in Persons With TBI | 2026-12 |
| NCT06584591Kessler FoundationNEUROBALANCE Training to Improve Postural Control in Individuals With Traumatic Brain Injury | 2027-08 |
| NCT05048966Kessler FoundationComparison of Two Group Wellness Interventions for Individuals With Neurologic Conditions and Their Support Persons | 2027-09 |
Among the 44 studies in Brain Injuries, Traumatic by Kessler Foundation, from their registry updates:
Nothing recorded among them since 2026-09-25.
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The purpose of this research study is to investigate the effects of a home-based 3-month long walking exercise program on cognitive (thinking) performance in persons with TBI. As a participant, you will complete this 3-month exercise program now or after a 3-month wait period.
This study involves no in-person visits to Kessler Foundation and takes place at home.
The first study activity will last about 1 hour in total and will involve using videoconferencing software (Zoom) to take tests of thinking (e.g., matching shapes and number, learning a list of words). You will then complete several brief questionnaires about everyday activities and TBI symptoms over the computer.
You will then be randomly picked (like the flip of a coin) by a computer to participate in one of two groups. You will have a 50/50 chance of being placed in either group.
One group will complete 3-months of walking exercise at home. The exercise program is based on activity guidelines for people with TBI and will be monitored by a trained exercise leader. You will be asked to walk 3 times per week. The first two weeks will require you to walk for 10 minutes at a time, and that duration will increase throughout the 3-months. You will have a dedicated trainer to help get started, answer questions, and support you throughout the programs. You will have regular meetings with this trainer by video conference (Zoom). You will be sent a FitBit to wear on your wrist while exercising to track your steps, and that you will be allowed to keep when the study ends.
The other group will stick to a regular routine during this 3-month period (i.e., wait-list group).
At the end of the 3-month exercise program, you will repeat the thinking tests and questionnaires. The wait-list group will be given the exercise prescription after this last Zoom session.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
One group will complete 3-months of walking exercise at home. The exercise program is based on activity guidelines for people with TBI and will be monitored by a trained exercise leader. You will be asked to walk 3 times per week. The first two weeks will require you to walk for 10 minutes at a time, and that duration will increase throughout the 3-months. You will have a dedicated trainer to help get started, answer questions, and support you throughout the programs. You will have regular meetings with this trainer by video conference (Zoom). You will be sent a FitBit to wear on your wrist while exercising to track your steps, and that you will be allowed to keep when the study ends.
Behavioral: Walking
The other group will stick to a regular routine during this 3-month period (i.e., wait-list group).
One group will complete 3-months of walking exercise at home. The exercise program is based on activity guidelines for people with TBI and will be monitored by a trained exercise leader. You will be asked to walk 3 times per week. The first two weeks will require you to walk for 10 minutes at a time, and that duration will increase throughout the 3-months. You will have a dedicated trainer to help get started, answer questions, and support you throughout the programs. You will have regular meetings with this trainer by video conference (Zoom). You will be sent a FitBit to wear on your wrist while exercising to track your steps, and that you will be allowed to keep when the study ends.
Adverse Events
Safety will be primarily measured as adverse events, specifically during the remote walking intervention.
Time frame: Through study completion, which is 3 months for intervention and 6 months for wait list.
Adherence
Adherence is measured as the number of exercise sessions attended compared to the number of total sessions prescribed.
Time frame: Through study completion, which is 3 months for intervention and 6 months for wait list.
Compliance
Compliance will be measured as the number of exercise sessions completed as prescribed (i.e., intensity and duration).
Time frame: Through study completion, which is 3 months for intervention and 6 months for wait list.
Processing Speed
Neuropsychological assessments will be administered to measure processing speed using the symbol digit modalities test (SDMT).
Time frame: Baseline and follow-up (12-weeks post-baseline)
Learning/Memory
Neuropsychological assessments will be administered to measure processing learning and memory using the California Verbal Learning Test (CVLT).
Time frame: Baseline and follow-up (12-weeks post-baseline)
Executive function
Neuropsychological assessments will be administered to measure executive function using the Delis-Kaplan Executive Function System (DKEFS).
Time frame: Baseline and follow-up (12-weeks post-baseline)
Plan to share: Yes — We plan to share sample data on safety measures, adherence, and compliance.
Supporting information: Study protocol, Statistical analysis plan
Time frame: These data will be shared upon completion of data collection (estimated 12/2026) and will be available for three years.
Access criteria: Interested parties can request data be shared directly form the PI.
No publications or documents are linked to this record.
Started Apr 2026 (actual). Primary completion is estimated for Dec 2026, 8 months after the start.
Of 27 phase 1 interventional studies under Brain Injuries, Traumatic, half reached primary completion within 52 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 66. This study's planned 8 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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