StrokeERA StrokeNCT06430632
Early Robotic Gait Training After Stroke
A study testing Robotic Gait Training in people with Stroke, run by Baylor Research Institute at 1 site in United States.
Trial summary
The ERA Stroke project will compare the effects of robotic gait training (RGT) and usual care (UC) gait training in patients in the subacute phase of stroke recovery undergoing inpatient rehabilitation at the Baylor Scott \& White Institute for Rehabilitation (BSWIR). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke
- What is being tested?
- Robotic Gait Training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2024to Dec 2026
- Phase
- Interventional
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-85 years of age
- All types of stroke
- Acute/subacute phase of recovery
- Medically stable as deemed by a physician
- Undergoing medical care and rehabilitation at BSWIR
- All genders, races, and ethnicities
Show all 9Show fewer
- Meets Ekso robotic exoskeleton frame limitations
- Continence or on a program for bladder and bowel management
- Capacity and goal for walking recovery
Who cannot join
- Concurrent neurological diagnoses (e.g., TBI, degenerative, CNS neoplasm)
- Profound cognitive impairment
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Baylor Scott & White Institute for Rehabilitation
Dallas, Texas, 75246
Baylor Scott & White Institute for Rehabilitation
Chad Swank, PT, PhD
About this study
The ERA Stroke project will compare the effects of robotic gait training (RGT) and usual care (UC) gait training in patients in the subacute phase of stroke recovery undergoing inpatient rehabilitation at the Baylor Scott \& White Institute for Rehabilitation (BSWIR).
Read the detailed description
Importance: Stroke is estimated to affect 6.6 million Americans, and around 795,000 new cases are reported each year. By 2030, annual stroke-related healthcare costs are expected to eclipse $240 billion, a staggering 445% increase from the current annual cost of $53.9 billion. Specialized stroke rehabilitation reduces long-term disability and stroke-related costs, making cost-efficient efforts to minimize functional deficits faced by people with stroke (e.g., gait impairment) a high priority. This project will provision preliminary evidence regarding the clinical use and efficacy of robotic gait training (RGT) during the subacute phase of stroke recovery as well as observational findings associated with the safety, tolerability, feasibility, and cost of delivering RGT during inpatient stroke rehabilitation. Its results will help with developing safe, tolerable, and cost-effective training protocols to improve walking function after stroke. Additionally, follow-up assessments after discharge will investigate any carryover effect of RGT, providing foundational data to evaluate the dose-response relationship for delivering RGT during inpatient rehabilitation after stroke. Altogether, this evidence will help stroke rehabilitation programs to assess their planning and budgeting needs prior to adopting RGT technology, improving outcomes and lowering lifetime care costs for patients with stroke.
Aims: (1) Evaluate the safety, tolerability, and feasibility of delivering an RGT intervention that meets the unique needs of people after stroke during inpatient rehabilitation informed by an Advisory Board comprised of stakeholders living with stroke. (2) Examine the efficacy of RGT compared to usual care (UC) gait training during inpatient rehabilitation for people with stroke. (3) Conduct a cost analysis of delivering RGT during inpatient rehabilitation compared to UC.
Methods: This randomized controlled trial will enroll 54 patients admitted to the Baylor Scott and White Institute for Rehabilitation following stroke. Participants will be randomized to either the experimental group receiving RGT or the control group receiving UC.
Addition to State-of-the-Art: Expected products include a manualized, stakeholder-informed RGT intervention and cost-analysis template that can be replicated across early rehabilitation settings nationally for people with stroke.
Sustained Approach: This project builds upon our earlier findings to achieve optimal walking recovery post-stroke during inpatient rehabilitation. The proposed work will generate preliminary efficacy, safety, tolerability, feasibility, and cost-analysis data concerning delivering an RGT intervention during the subacute phase for people with stroke.
- Conditions
- Stroke
- Being tested
- Robotic Gait Training, Usual Care Gait Training
- Keywords
- Exoskeleton, Gait training, Inpatient rehabilitation, Physical therapy, Physical rehabilitation and medicine, Randomized controlled trial, Robotic gait training
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic Gait TrainingDevice
Also called EksoNR Robotic Exoskeleton
Participants will complete standing and walking activities while wearing a robotic exoskeleton. Participants will also be asked to complete questionnaires about their walking and function.
Usual Care Gait TrainingOther
Also called Standard of Care Gait Training
Participants will complete standing and walking activities such as body weight-supported treadmill training and conventional overground walking. Participants will also be asked to complete questionnaires about their walking and function.
| Study group | Role | What they receive |
|---|---|---|
| Robotic Gait Training | Experimental | Participants will receive robotic gait training with a physical therapist for 90 minutes each week throughout the course of their inpatient rehabilitation stay. Receives: Device: Robotic Gait Training |
| Usual Care Gait Training | Active comparator | Participants will receive usual care gait training with a physical therapist for 90 minutes each week throughout the course of their inpatient rehabilitation stay. Receives: Other: Usual Care Gait Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait speed via 10-Meter Walk Test (10MWT)
The 10MWT assesses gait speed over a short duration. Gait speed (m/s) is correlated with ability to mobilize in the community, capacity to perform activities of daily living, and risk of falls, re-hospitalization, and cognitive decline. The 10MWT can be used to categorize individuals according to their ambulatory ability: household ambulators (<0.4 m/s), limited community ambulators (0.4 to 0.8 m/s), and community ambulators (>0.8 m/s). Score changes >0.16 m/s exceed the MCID. Normal gait speed for adults older than 50 years is >1.27 m/s.
Measured: within 7 days of admission to inpatient rehabilitation, within 7 days of discharge from inpatient rehabilitation, 1 month (±14 days) after discharge from inpatient rehabilitation, 3 months (±14 days) after discharge from inpatient rehabilitation
Secondary outcomes (11)
Functional Ambulation Category (FAC)
The FAC assesses functional ambulation in patients undergoing rehabilitation and has excellent reliability, good predictive validity, and good responsiveness in patients with stroke. Scores range from 0 (unable to walk) to 5 (independent walking anywhere). After 4 weeks of rehabilitation, FAC scores ≥4 predict community ambulation at 6 months with 100% sensitivity and 78% specificity.
Measured: within 7 days of admission to inpatient rehabilitation, within 7 days of discharge from inpatient rehabilitation, 1 month (±14 days) after discharge from inpatient rehabilitation, 3 months (±14 days) after discharge from inpatient rehabilitation
Continuity Assessment Record and Evaluation (CARE)
The Section GG CARE is utilized in post-acute care settings for tracking progress across the continuum of care and is conducted at admission and discharge. The CARE addresses self-care (GG0130, 8 items) and functional mobility (GG0170, 17 items). Scores for each item range from 1 (dependent) to 6 (independent). Total scores for the CARE have strong positive correlations with total scores for the Functional Independence Measure.
Measured: within 7 days of admission to inpatient rehabilitation, within 7 days of discharge from inpatient rehabilitation, 1 month (±14 days) after discharge from inpatient rehabilitation, 3 months (±14 days) after discharge from inpatient rehabilitation
6-Minute Walk Test (6MWT)
The 6MWT assesses distance walked over 6 minutes as a sub-maximal test of walking capacity. Endurance (captured as walking capacity) is essential to participate in community-based activities. With excellent test-retest reliability (ICC = 0.99) for people with stroke, the established MCID is 34.4 meters.
Measured: within 7 days of admission to inpatient rehabilitation, within 7 days of discharge from inpatient rehabilitation, 1 month (±14 days) after discharge from inpatient rehabilitation, 3 months (±14 days) after discharge from inpatient rehabilitation
Modified Rankin Scale (mRS)
The mRS measures the degree of disability or dependence in the daily activities of people who have had a stroke. The mRS is an ordinal scale with 6 categories ranging from 0 (no symptoms) to 5 (complete physical dependence).
Measured: within 7 days of admission to inpatient rehabilitation, within 7 days of discharge from inpatient rehabilitation, 1 month (±14 days) after discharge from inpatient rehabilitation, 3 months (±14 days) after discharge from inpatient rehabilitation
Stroke Rehabilitation Assessment of Movement (STREAM)
The STREAM assesses upper and lower limb motor function along with basic mobility in people with stroke and has a very high inter-rater reliability (ICC = 0.96). MCID values have been established for the upper extremity (2.2 points), lower extremity (1.9 points), and mobility (4.8 points) subscales.
Measured: within 7 days of admission to inpatient rehabilitation, within 7 days of discharge from inpatient rehabilitation, 1 month (±14 days) after discharge from inpatient rehabilitation, 3 months (±14 days) after discharge from inpatient rehabilitation
5 Times Sit-to-Stand Test (5TSST)
The 5TSST assesses lower extremity strength and is an indicator of postural control. People with stroke who score >15 seconds are considered at risk for falls. Normal scores for individuals aged 60-80 years range from 11.4 to 12.7 seconds. The 5TSST has demonstrated excellent test-retest reliability (ICC = 0.95) with an established MDC95 of 2.3 seconds.
Measured: within 7 days of admission to inpatient rehabilitation, within 7 days of discharge from inpatient rehabilitation, 1 month (±14 days) after discharge from inpatient rehabilitation, 3 months (±14 days) after discharge from inpatient rehabilitation
Berg Balance Scale (BBS)
The BBS is a 14-item objective measure that assesses static balance and fall risk in adults. With excellent reliability (ICC = 0.95), the BBS has a large responsiveness for acute stroke (effect size = 0.85) and a minimal detectable change of 6.9 points. Scores <45/56 indicate a risk of falling.
Measured: within 7 days of admission to inpatient rehabilitation, within 7 days of discharge from inpatient rehabilitation, 1 month (±14 days) after discharge from inpatient rehabilitation, 3 months (±14 days) after discharge from inpatient rehabilitation
Stroke Impact Scale - 16 (SIS-16)
The SIS-16 assesses 4 dimensions of health-related QOLs specific to people who have had a stroke. It includes subscales that assess strength, hand function, mobility, and activities of daily living via 5-point Likert scales.
Measured: within 7 days of admission to inpatient rehabilitation, within 7 days of discharge from inpatient rehabilitation, 1 month (±14 days) after discharge from inpatient rehabilitation, 3 months (±14 days) after discharge from inpatient rehabilitation
Rating of Perceived Exertion (RPE)
The Borg RPE is a 15-point scale with verbal descriptors to standardize perceived exertion across tasks and individuals. Participants will be asked to provide a self-reported intensity level on the Borg Rating of Perceived Exertion Scale during RGT and UC gait training sessions. A self-report of 12 to 14 on the RPE indicates moderate intensity.
Measured: immediately following every treatment session until discharge from inpatient rehabilitation (an average of 2 weeks)
Number of steps (RGT only)
The Ekso device records several data points for each session including number of steps, "Up" time (the amount of time spent standing in the device), "Walk" time (the amount of time spent walking in the device), and device assistance scores. While all of these data values will be recorded to describe each RGT session and tracked to monitor progression of the RGT intervention, the number of steps per session will be utilized as an indicator of RGT session intensity.
Measured: immediately following every treatment session until discharge from inpatient rehabilitation (an average of 2 weeks)
Distance walked (UC only)
Distance walked will be recorded to describe each UC session, tracked to monitor progression of the UC intervention, and utilized as an indicator of UC session intensity.
Measured: immediately following every treatment session until discharge from inpatient rehabilitation (an average of 2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2024
- Study start1 Mar 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to either the experimental group receiving robotic gait training or the control group receiving usual care gait training.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Disability, Independent Living, and Rehabilitation Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06430632
- Sponsor's protocol ID
- 023-471
- Other IDs
- 90IFRE0074
- Acronym
- ERA Stroke
- Status last verified
- Feb 2026
- First submitted
- 9 May 2024
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
da Silva Areas FZ, Baltz S, Gillespie J, Ochoa C, Gilliland T, Dubiel R, Bennett M, Driver S, Swank C. Early robotic gait training after stroke (ERA Stroke): study protocol for a randomized clinical trial. BMC Neurol. 2024 Oct 18;24(1):401. doi: 10.1186/s12883-024-03858-y.
PubMed 39425088
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Robotic Gait Training After Stroke
- ClinicalTrials.gov ID
- NCT06430632
- Acronym / sponsor ID
- ERA Stroke / 023-471
- Conditions
- Stroke
- Keywords
- Exoskeleton, Gait training, Inpatient rehabilitation, Physical therapy, Physical rehabilitation and medicine, Randomized controlled trial, Robotic gait training
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Collaborators
- National Institute on Disability, Independent Living, and Rehabilitation Research
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 28 May 2024 (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 ERA Stroke project will compare the effects of robotic gait training (RGT) and usual care (UC) gait training in patients in the subacute phase of stroke recovery undergoing inpatient rehabilitation at the Baylor Scott \& White Institute for Rehabilitation (BSWIR).
Detailed description
Importance: Stroke is estimated to affect 6.6 million Americans, and around 795,000 new cases are reported each year. By 2030, annual stroke-related healthcare costs are expected to eclipse $240 billion, a staggering 445% increase from the current annual cost of $53.9 billion. Specialized stroke rehabilitation reduces long-term disability and stroke-related costs, making cost-efficient efforts to minimize functional deficits faced by people with stroke (e.g., gait impairment) a high priority. This project will provision preliminary evidence regarding the clinical use and efficacy of robotic gait training (RGT) during the subacute phase of stroke recovery as well as observational findings associated with the safety, tolerability, feasibility, and cost of delivering RGT during inpatient stroke rehabilitation. Its results will help with developing safe, tolerable, and cost-effective training protocols to improve walking function after stroke. Additionally, follow-up assessments after discharge will investigate any carryover effect of RGT, providing foundational data to evaluate the dose-response relationship for delivering RGT during inpatient rehabilitation after stroke. Altogether, this evidence will help stroke rehabilitation programs to assess their planning and budgeting needs prior to adopting RGT technology, improving outcomes and lowering lifetime care costs for patients with stroke.
Aims: (1) Evaluate the safety, tolerability, and feasibility of delivering an RGT intervention that meets the unique needs of people after stroke during inpatient rehabilitation informed by an Advisory Board comprised of stakeholders living with stroke. (2) Examine the efficacy of RGT compared to usual care (UC) gait training during inpatient rehabilitation for people with stroke. (3) Conduct a cost analysis of delivering RGT during inpatient rehabilitation compared to UC.
Methods: This randomized controlled trial will enroll 54 patients admitted to the Baylor Scott and White Institute for Rehabilitation following stroke. Participants will be randomized to either the experimental group receiving RGT or the control group receiving UC.
Addition to State-of-the-Art: Expected products include a manualized, stakeholder-informed RGT intervention and cost-analysis template that can be replicated across early rehabilitation settings nationally for people with stroke.
Sustained Approach: This project builds upon our earlier findings to achieve optimal walking recovery post-stroke during inpatient rehabilitation. The proposed work will generate preliminary efficacy, safety, tolerability, feasibility, and cost-analysis data concerning delivering an RGT intervention during the subacute phase for people with stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized to either the experimental group receiving robotic gait training or the control group receiving usual care gait training.
| Arm | Type | Receives |
|---|---|---|
| Robotic Gait Training | Experimental | Device: Robotic Gait TrainingParticipants will receive robotic gait training with a physical therapist for 90 minutes each week throughout the course of their inpatient rehabilitation stay. |
| Usual Care Gait Training | Active comparator | Other: Usual Care Gait TrainingParticipants will receive usual care gait training with a physical therapist for 90 minutes each week throughout the course of their inpatient rehabilitation stay. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 18-85 years of age
- All types of stroke
- Acute/subacute phase of recovery
- Medically stable as deemed by a physician
- Undergoing medical care and rehabilitation at BSWIR
Key exclusion criteria (3 listed)
- Concurrent neurological diagnoses (e.g., TBI, degenerative, CNS neoplasm)
- Profound cognitive impairment
- Pregnancy
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 |
|---|---|---|
| Robotic Gait TrainingAlso: EksoNR Robotic ExoskeletonParticipants will complete standing and walking activities while wearing a robotic exoskeleton. Participants will also be asked to complete questionnaires about their walking and function. | Device | Robotic Gait Training |
| Usual Care Gait TrainingAlso: Standard of Care Gait TrainingParticipants will complete standing and walking activities such as body weight-supported treadmill training and conventional overground walking. Participants will also be asked to complete questionnaires about their walking and function. | Other | Usual Care Gait Training |
Primary outcome
Gait speed via 10-Meter Walk Test (10MWT)
Time frame: within 7 days of admission to inpatient rehabilitation, within 7 days of discharge from inpatient rehabilitation, 1 month (±14 days) after discharge from inpatient rehabilitation, 3 months (±14 days) after discharge from inpatient rehabilitation
The 10MWT assesses gait speed over a short duration. Gait speed (m/s) is correlated with ability to mobilize in the community, capacity to perform activities of daily living, and risk of falls, re-hospitalization, and cognitive decline. The 10MWT can be used to categorize individuals according to their ambulatory ability: household ambulators (<0.4 m/s), limited community ambulators (0.4 to 0.8 m/s), and community ambulators (>0.8 m/s). Score changes >0.16 m/s exceed the MCID. Normal gait speed for adults older than 50 years is >1.27 m/s.
11 secondary outcomes
Functional Ambulation Category (FAC)
Time frame: within 7 days of admission to inpatient rehabilitation, within 7 days of discharge from inpatient rehabilitation, 1 month (±14 days) after discharge from inpatient rehabilitation, 3 months (±14 days) after discharge from inpatient rehabilitation
Continuity Assessment Record and Evaluation (CARE)
Time frame: within 7 days of admission to inpatient rehabilitation, within 7 days of discharge from inpatient rehabilitation, 1 month (±14 days) after discharge from inpatient rehabilitation, 3 months (±14 days) after discharge from inpatient rehabilitation
6-Minute Walk Test (6MWT)
Time frame: within 7 days of admission to inpatient rehabilitation, within 7 days of discharge from inpatient rehabilitation, 1 month (±14 days) after discharge from inpatient rehabilitation, 3 months (±14 days) after discharge from inpatient rehabilitation
Modified Rankin Scale (mRS)
Time frame: within 7 days of admission to inpatient rehabilitation, within 7 days of discharge from inpatient rehabilitation, 1 month (±14 days) after discharge from inpatient rehabilitation, 3 months (±14 days) after discharge from inpatient rehabilitation
Stroke Rehabilitation Assessment of Movement (STREAM)
Time frame: within 7 days of admission to inpatient rehabilitation, within 7 days of discharge from inpatient rehabilitation, 1 month (±14 days) after discharge from inpatient rehabilitation, 3 months (±14 days) after discharge from inpatient rehabilitation
5 Times Sit-to-Stand Test (5TSST)
Time frame: within 7 days of admission to inpatient rehabilitation, within 7 days of discharge from inpatient rehabilitation, 1 month (±14 days) after discharge from inpatient rehabilitation, 3 months (±14 days) after discharge from inpatient rehabilitation
Berg Balance Scale (BBS)
Time frame: within 7 days of admission to inpatient rehabilitation, within 7 days of discharge from inpatient rehabilitation, 1 month (±14 days) after discharge from inpatient rehabilitation, 3 months (±14 days) after discharge from inpatient rehabilitation
Stroke Impact Scale - 16 (SIS-16)
Time frame: within 7 days of admission to inpatient rehabilitation, within 7 days of discharge from inpatient rehabilitation, 1 month (±14 days) after discharge from inpatient rehabilitation, 3 months (±14 days) after discharge from inpatient rehabilitation
Rating of Perceived Exertion (RPE)
Time frame: immediately following every treatment session until discharge from inpatient rehabilitation (an average of 2 weeks)
Number of steps (RGT only)
Time frame: immediately following every treatment session until discharge from inpatient rehabilitation (an average of 2 weeks)
Distance walked (UC only)
Time frame: immediately following every treatment session until discharge from inpatient rehabilitation (an average of 2 weeks)
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 6 Feb 2026.
- Derived from this study: PubMed 39425088da Silva Areas FZ, Baltz S, Gillespie J, Ochoa C, Gilliland T, Dubiel R, Bennett M, Driver S, Swank C. Early robotic gait training after stroke (ERA Stroke): study protocol for a randomized clinical trial. BMC Neurol. 2024 Oct 18;24(1):401. doi: 10.1186/s12883-024-03858-y.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic Gait Training in people with Stroke, run by Baylor Research Institute 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 9 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 6 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 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.
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?
Contact Sara Baltz, MS ((214) 820-5022, Sara.Baltz@BSWHealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait speed via 10-Meter Walk Test (10MWT) (time frame: within 7 days of admission to inpatient rehabilitation, within 7 days of discharge from inpatient rehabilitation, 1 month (±14 days) after discharge from inpatient rehabilitation, 3 months (±14 days) after discharge from inpatient rehabilitation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06430632, which also lists 1 linked publication.
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 6 Feb 2026.