StrokeBLASTNCT02688777
A Novel Strategy to Decrease Fall Incidence Post-Stroke
A study testing Backward Walking Training in people with Stroke, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Approximately 15,000 Veterans are hospitalized for stroke each year with new cases costing an estimated $111 million for acute inpatient, $75 million for post-acute inpatient, and $88 million for follow-up care over 6 months post-stroke. Contributing to these costs is the incidence of falls. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Stroke
- What is being tested?
- Backward Walking Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2017to 11 Feb 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Berg Balance Scale < 42
- Self-selected 10 meter gait speed < 0.8 m/s
- Diagnosis of unilateral stroke
- > 2 months < 4 months post-stroke
- Able to ambulate at least 10 feet with maximum 1 person assist
- Medically stable
- 18-85 years of age
- Physician approval for patient participation
Who cannot join
- Presence of neurological condition other than stroke
- Serious cardiac conditions
- hospitalization for myocardial infarction or heart surgery within 3 months
- history of congestive heart failure
- documented serious and unstable cardiac arrhythmias
- hypertrophic cardiomyopathy
Show all 28Show fewer
- severe aortic stenosis
- angina or dyspnea at rest or during activities of daily living
- Anyone meeting New York Heart Association criteria for Class 3 or Class 4 heart disease will be excluded
- Severe arthritis or orthopedic problems that limit passive ranges of motion of lower extremity
- knee flexion contracture of -10
- knee flexion Range Of Motion < 90
- hip flexion contracture > 25
- ankle plantar flexion contracture > 15
- Severe hypertension with systolic greater than 200 mmHg and diastolic greater than 110 mmHg at rest, that cannot be medically controlled into the resting range of 180/100 mmHg
- Pain upon ambulation
- Receiving physical therapy services for mobility and/or gait
- Living in a skilled nursing facility
- Unable to ambulate at least 150 feet prior to stroke, or experienced intermittent claudication while walking less than 200 meters
- History of serious chronic obstructive pulmonary disease or oxygen independence
- Non-healing ulcers on the lower extremity
- Uncontrollable diabetes with recent weight loss, diabetic coma or frequent insulin reactions
- On renal dialysis or presence of end stage liver disease
- Pulmonary embolism within previous 6 months
- History of major head trauma
- History of sustained alcoholism or drug abuse in the last six months
- Intracranial hemorrhage related to aneurysmal rupture or an arteriovenous malformation
- Current enrollment in a clinical trial to enhance stroke motor recovery
Trial locations and contacts
1 site in 1 country.
United States1 site
North Florida/South Georgia Veterans Health System, Gainesville, FL
Gainesville, Florida, 32608
About this study
Approximately 15,000 Veterans are hospitalized for stroke each year with new cases costing an estimated $111 million for acute inpatient, $75 million for post-acute inpatient, and $88 million for follow-up care over 6 months post-stroke. Contributing to these costs is the incidence of falls. Falls are a costly complication for Veterans with stroke as they lead to an increased incidence of fractures, depression, and mortality. New strategies are needed to help Veterans post-stroke regain their ability to safely walk without increasing their risk of falling as well as readily identify those who are a fall risk. This study addresses both of these needs as it will 1) investigate a new treatment approach, backward walking training, to determine if it will decrease fall incidence in the first year post-stroke and 2) determine if backward walking speed early after a stroke can identify those that are at risk for future falls.
Read the detailed description
Approximately 15,000 Veterans are hospitalized for stroke each year. Persistent walking and balance deficits contribute to long-term disability and a high incidence of falls. Falls are a common and costly complication of stroke; between 40% and 70% of affected individuals fall within the first year. Falls lead to fear of falling, limitations in self-care and increased dependence. Of greater concern, they lead to serious adverse events, including fractures, depression and mortality. A primary goal of stroke rehabilitation is to improve mobility despite persistent motor, balance and visual-spatial deficits. However, this goal has a down side since it increases fall risks. Here, the investigators propose a novel therapeutic strategy to improve ambulation while decreasing the risk of falls: Backward Walking Training (BWTraining).
The investigators' central hypothesis is that a 6-week BWTraining program at 2-months post-stroke is superior to standard care in reducing falls within the 1st year post-stroke. Identification of those at risk for falling is a necessary component of post-stroke rehabilitation to implement pro-active measures to decrease risk once individuals rejoin community living. Recent research in a cohort of elderly adults determined that maximal Backward Walking Speed (BWSpeed) (not forward) identified individuals that had experienced a fall in the previous six months,6 suggesting that BWSpeed could be a simple, inexpensive screening tool to identify individuals at risk of falling. With a randomized, blinded design, the investigators propose to prospectively assess the value of BWSpeed as a tool to predict future falls.
A notable post-stroke conundrum is that increased mobility may increase fall risk.5 On the other hand, limiting mobility leads to a multitude of inactivity-associated deficits, including recurrent stroke.
To date, no intervention has demonstrated efficacy for improving walking while minimizing fall risk. BWTraining may be a simple and effective intervention to achieve both goals. In the investigators' recent randomized controlled pilot trial (RCT), individuals with sub-acute stroke who participated in a BWTraining demonstrated 3-fold improvement in backward and forward walking speed and fall self-efficacy. Further, BWTraining caused 75% greater improvement in balance versus those in a dose-matched balance training group. At the 3-month follow-up assessment, BWSpeed of the BWTraining group averaged 0.63 m/s, exceeding the threshold for fall risk in elderly adults.
Given the success of the investigators' pilot intervention, a larger and more rigorous trial is needed to demonstrate reduced fall incidence over an extended follow-up period. The investigators designed this RCT to address three specific aims:
Aim #1: Test the hypothesis that 1-year fall incidence is decreased for participants randomized to BWTraining administered at 2-months post-stroke (versus usual care comparison group).
Hypothesis #1a: BWTraining at 2-months post-stroke reduces the number of falls over the next year.
Hypothesis #1b: BWTraining at 2-months post-stroke increases gait speed, improves balance and increases balance confidence over the next year.
Aim #2: Test the hypothesis that BWTraining at 2 months (immediate) vs. 1-year (delayed) post-stroke is more effective at improving BWSpeed.
Hypothesis #2a: BWSpeed improvement from 2- to 14-months post-stroke is greater when BWTraining is delivered at 2 months versus 1 year post-stroke.
Hypothesis #2b: Improvements in forward gait speed, Functional Gait Assessment and Activities-Balance Confidence Scale from 2- to 14-months post-stroke are greater when BWTraining is delivered at 2 months versus 1 year post-stroke.
Aim #3: This exploratory aim will test the hypothesis that BWSpeed at 2-months post-stroke is a significant predictor of fall incidence over the next year 1 year period, after adjusting for other covariates.
Hypothesis #3: BWSpeed at 2-months will be a significant predictor of fall incidence during the first year post-stroke, after adjusting for other covariates.
This study is significant since it concerns a novel strategy to improve ambulation while minimizing the risk of falling after a stroke. BWTraining is highly novel, is easy to administer and exciting preliminary data suggest that is has major potential as a therapeutic tool. In addition, the investigators will determine the potential of BWSpeed (a simple, clinically relevant screening tool) to identify those at risk for future falls.
- Conditions
- Stroke
- Being tested
- Backward Walking Training
- Keywords
- Rehabilitation, Gait, Postural Balance, Exercise, Accidental Falls, Kinesiology, Applied
- Medical subject headings
- Stroke, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Backward Walking TrainingBehavioural
Backward Walking Training will occur both on a treadmill and overground. In brief, BWTraining will consist of 20-30 minutes of step training with a Body Weight Support and Treadmill system (BWST), rest periods provided as warranted, with manual assistance provided by trainers, followed by 15 minutes of overground gait training. A 20-30 min period of actual stepping is the goal for the intervention sessions on the treadmill with rest periods as needed. Each training session may last up to 1 hour and 30 minutes including time for warm-up, stretching, and cool down. Participants will be fitted with a harness around their hips and torso, which will be attached to an overhead support system directly above the treadmill. From a stationary position, the treadmill belt will gradually be increased in speed with intervention trainers assisting participant to step backward with their paretic leg, their non-paretic leg (if needed) and at the hips for weight-shift.
| Study group | Role | What they receive |
|---|---|---|
| Immediate Backward Walking Training | Experimental | Individuals will participate in 18 sessions of Backward Walking training immediately following baseline assessment. Receives: Behavioral: Backward Walking Training |
| Delayed Backward Walking Training | Active comparator | Individuals will participate in 18 sessions of Backward Walking training at 1-year post-strokeD Receives: Behavioral: Backward Walking Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fall Incidence (Number of Falls)
Fall incidence will be monitored using the international standards for defining and reporting falls,60 including the following definition for a fall: "A person has a fall if they end up on the ground or floor when they did not expect to. Most often a fall starts while a person is on their feet, but a fall could also start from a chair or bed. If a person ends up on the ground, either on their knees, their belly, their side, their bottom, or their back, they have had a fall." This explanation will be provided to participants and caregivers and printed on monthly calendars issued at randomization. The number of falls will be recorded on a monthly basis and then added across months to determine the number of recorded falls between baseline and 1-year post-stroke.
Measured: Number of recorded falls between baseline and 1-year post-stroke
Secondary outcomes (12)
10 Meter Walk Test
Individuals will be given a 2 meter warm-up distance for walking, preceding the 10 meter distance and 2 meters beyond the 10 meters to continue walking. The time that it takes to traverse the 10 meters at the subject's usual pace will be recorded.
Measured: Change between baseline and 1-year post-stroke
3-Meter Backward Walk Test
The test consists of a 1 meter warm-up distance, a timed 3 meter distance, followed by an additional 1 meter to continue walking An average of two trials will be recorded.
Measured: Change between baseline and 1-year post-stroke
Functional Gait Assessment
A 10-item clinical gait and balance test during which participants perform the following activities: walk at normal speeds, at fast and slow speeds, with vertical and horizontal head turns, with eyes closed, over obstacles, in tandem, backward and while ascending and descending stairs.
Minimum value: 0 Maximum value: 40 Higher score = better outcome
Measured: Change between baseline and 1-year post-stroke
Activities-Specific Balance Confidence Scale
This 16-item self-report measure is used to assess perceived efficacy (self-reported confidence) in maintaining balance while performing a number of activities common in community-dwelling older adults.
Minimum value: 0% Maximum value: 100% Higher score = better outcome
Measured: Change between baseline and 1-year post-stroke
Berg Balance Scale
This tool consists of 14 items that assesses static and dynamic standing balance, ability to sit, stand up and transfer.
Minimum Value: 0 Maximum Value 56 Higher score = better outcome
Measured: Change between baseline and 1-year post-stroke
Lower-Extremity Fugl-Meyer Motor Score
This tool consists of 17 items that assess motor control of the lower extremity as participants move their hip, knee and ankle in lying, sitting and standing.
Minimum score=0 Maximum score = 34 Higher score = better outcome
Measured: Change between baseline and 1-year post-stroke
Four-Step Square Test
This clinical test of dynamic standing balance examines the ability to step over small objects, change direction and includes taking a backwards step.
Measured: Change between baseline and 1-year post-stroke
Stride Time
Stride time will be captured during forward and backward walking across a pressure-sensitive instrumented walkway.
Measured: Change between baseline and 1-year post-stroke
Stride Length
Stride length will be captured during forward and backward walking across a GAITRite instrumented walkway.
Measured: Change between baseline and 1-year post-stroke
Step Time
Step time will be captured during forward and backward walking across a GAITRite instrumented walkway.
Measured: Change between baseline and 1-year post-stroke
Step Length
Step length will be captured during forward and backward walking across a GAITRite instrumented walkway.
Measured: Change between baseline and 1-year post-stroke
Step Width
Step width will be captured during forward and backward walking across a GAITRite instrumented walkway.
Measured: Change between baseline and 1-year post-stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2016 (estimated)
- Study start14 Aug 2017
- Primary completion30 Sep 2021
- Study completion11 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel: participants are assigned to one of two or more groups in parallel for the duration of the study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Dorian Kay Rose, PhD MS BS, Principal investigator, North Florida/South Georgia Veterans Health System, Gainesville, FL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02688777
- Sponsor's protocol ID
- N2004-R
- Acronym
- BLAST
- Status last verified
- Nov 2023
- First submitted
- 17 Feb 2016
- Last updated
- 24 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Strategy to Decrease Fall Incidence Post-Stroke
- ClinicalTrials.gov ID
- NCT02688777
- Acronym / sponsor ID
- BLAST / N2004-R
- Conditions
- Stroke
- Keywords
- Rehabilitation, Gait, Postural Balance, Exercise, Accidental Falls, Kinesiology, Applied
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 14 Aug 2017 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 11 Feb 2022 (actual)
- First posted
- 23 Feb 2016 (estimated)
- Results
- Posted 24 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Approximately 15,000 Veterans are hospitalized for stroke each year with new cases costing an estimated $111 million for acute inpatient, $75 million for post-acute inpatient, and $88 million for follow-up care over 6 months post-stroke. Contributing to these costs is the incidence of falls. Falls are a costly complication for Veterans with stroke as they lead to an increased incidence of fractures, depression, and mortality. New strategies are needed to help Veterans post-stroke regain their ability to safely walk without increasing their risk of falling as well as readily identify those who are a fall risk. This study addresses both of these needs as it will 1) investigate a new treatment approach, backward walking training, to determine if it will decrease fall incidence in the first year post-stroke and 2) determine if backward walking speed early after a stroke can identify those that are at risk for future falls.
Detailed description
Approximately 15,000 Veterans are hospitalized for stroke each year. Persistent walking and balance deficits contribute to long-term disability and a high incidence of falls. Falls are a common and costly complication of stroke; between 40% and 70% of affected individuals fall within the first year. Falls lead to fear of falling, limitations in self-care and increased dependence. Of greater concern, they lead to serious adverse events, including fractures, depression and mortality. A primary goal of stroke rehabilitation is to improve mobility despite persistent motor, balance and visual-spatial deficits. However, this goal has a down side since it increases fall risks. Here, the investigators propose a novel therapeutic strategy to improve ambulation while decreasing the risk of falls: Backward Walking Training (BWTraining).
The investigators' central hypothesis is that a 6-week BWTraining program at 2-months post-stroke is superior to standard care in reducing falls within the 1st year post-stroke. Identification of those at risk for falling is a necessary component of post-stroke rehabilitation to implement pro-active measures to decrease risk once individuals rejoin community living. Recent research in a cohort of elderly adults determined that maximal Backward Walking Speed (BWSpeed) (not forward) identified individuals that had experienced a fall in the previous six months,6 suggesting that BWSpeed could be a simple, inexpensive screening tool to identify individuals at risk of falling. With a randomized, blinded design, the investigators propose to prospectively assess the value of BWSpeed as a tool to predict future falls.
A notable post-stroke conundrum is that increased mobility may increase fall risk.5 On the other hand, limiting mobility leads to a multitude of inactivity-associated deficits, including recurrent stroke.
To date, no intervention has demonstrated efficacy for improving walking while minimizing fall risk. BWTraining may be a simple and effective intervention to achieve both goals. In the investigators' recent randomized controlled pilot trial (RCT), individuals with sub-acute stroke who participated in a BWTraining demonstrated 3-fold improvement in backward and forward walking speed and fall self-efficacy. Further, BWTraining caused 75% greater improvement in balance versus those in a dose-matched balance training group. At the 3-month follow-up assessment, BWSpeed of the BWTraining group averaged 0.63 m/s, exceeding the threshold for fall risk in elderly adults.
Given the success of the investigators' pilot intervention, a larger and more rigorous trial is needed to demonstrate reduced fall incidence over an extended follow-up period. The investigators designed this RCT to address three specific aims:
Aim #1: Test the hypothesis that 1-year fall incidence is decreased for participants randomized to BWTraining administered at 2-months post-stroke (versus usual care comparison group).
Hypothesis #1a: BWTraining at 2-months post-stroke reduces the number of falls over the next year.
Hypothesis #1b: BWTraining at 2-months post-stroke increases gait speed, improves balance and increases balance confidence over the next year.
Aim #2: Test the hypothesis that BWTraining at 2 months (immediate) vs. 1-year (delayed) post-stroke is more effective at improving BWSpeed.
Hypothesis #2a: BWSpeed improvement from 2- to 14-months post-stroke is greater when BWTraining is delivered at 2 months versus 1 year post-stroke.
Hypothesis #2b: Improvements in forward gait speed, Functional Gait Assessment and Activities-Balance Confidence Scale from 2- to 14-months post-stroke are greater when BWTraining is delivered at 2 months versus 1 year post-stroke.
Aim #3: This exploratory aim will test the hypothesis that BWSpeed at 2-months post-stroke is a significant predictor of fall incidence over the next year 1 year period, after adjusting for other covariates.
Hypothesis #3: BWSpeed at 2-months will be a significant predictor of fall incidence during the first year post-stroke, after adjusting for other covariates.
This study is significant since it concerns a novel strategy to improve ambulation while minimizing the risk of falling after a stroke. BWTraining is highly novel, is easy to administer and exciting preliminary data suggest that is has major potential as a therapeutic tool. In addition, the investigators will determine the potential of BWSpeed (a simple, clinically relevant screening tool) to identify those at risk for future falls.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel: participants are assigned to one of two or more groups in parallel for the duration of the study.
| Arm | Type | Receives |
|---|---|---|
| Immediate Backward Walking Training | Experimental | Behavioral: Backward Walking TrainingIndividuals will participate in 18 sessions of Backward Walking training immediately following baseline assessment. |
| Delayed Backward Walking Training | Active comparator | Behavioral: Backward Walking TrainingIndividuals will participate in 18 sessions of Backward Walking training at 1-year post-strokeD |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Berg Balance Scale < 42
- Self-selected 10 meter gait speed < 0.8 m/s
- Diagnosis of unilateral stroke
- > 2 months < 4 months post-stroke
- Able to ambulate at least 10 feet with maximum 1 person assist
Key exclusion criteria (28 listed)
- Presence of neurological condition other than stroke
- Serious cardiac conditions
- Anyone meeting New York Heart Association criteria for Class 3 or Class 4 heart disease will be excluded
- Severe arthritis or orthopedic problems that limit passive ranges of motion of lower extremity
- Severe hypertension with systolic greater than 200 mmHg and diastolic greater than 110 mmHg at rest, that cannot be medically controlled into the resting range of 180/100 mmHg
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 |
|---|---|---|
| Backward Walking TrainingBackward Walking Training will occur both on a treadmill and overground. In brief, BWTraining will consist of 20-30 minutes of step training with a Body Weight Support and Treadmill system (BWST), rest periods provided as warranted, with manual assistance provided by trainers, followed by 15 minutes of overground gait training. A 20-30 min period of actual stepping is the goal for the intervention sessions on the treadmill with rest periods as needed. Each training session may last up to 1 hour and 30 minutes including time for warm-up, stretching, and cool down. Participants will be fitted with a harness around their hips and torso, which will be attached to an overhead support system directly above the treadmill. From a stationary position, the treadmill belt will gradually be increased in speed with intervention trainers assisting participant to step backward with their paretic leg, their non-paretic leg (if needed) and at the hips for weight-shift. | Behavioural | Delayed Backward Walking Training, Immediate Backward Walking Training |
Primary outcome
Fall Incidence (Number of Falls)
Time frame: Number of recorded falls between baseline and 1-year post-stroke
Fall incidence will be monitored using the international standards for defining and reporting falls,60 including the following definition for a fall: "A person has a fall if they end up on the ground or floor when they did not expect to. Most often a fall starts while a person is on their feet, but a fall could also start from a chair or bed. If a person ends up on the ground, either on their knees, their belly, their side, their bottom, or their back, they have had a fall." This explanation will be provided to participants and caregivers and printed on monthly calendars issued at randomization. The number of falls will be recorded on a monthly basis and then added across months to determine the number of recorded falls between baseline and 1-year post-stroke.
12 secondary outcomes
10 Meter Walk Test
Time frame: Change between baseline and 1-year post-stroke
3-Meter Backward Walk Test
Time frame: Change between baseline and 1-year post-stroke
Functional Gait Assessment
Time frame: Change between baseline and 1-year post-stroke
Activities-Specific Balance Confidence Scale
Time frame: Change between baseline and 1-year post-stroke
Berg Balance Scale
Time frame: Change between baseline and 1-year post-stroke
Lower-Extremity Fugl-Meyer Motor Score
Time frame: Change between baseline and 1-year post-stroke
Four-Step Square Test
Time frame: Change between baseline and 1-year post-stroke
Stride Time
Time frame: Change between baseline and 1-year post-stroke
Stride Length
Time frame: Change between baseline and 1-year post-stroke
Step Time
Time frame: Change between baseline and 1-year post-stroke
Step Length
Time frame: Change between baseline and 1-year post-stroke
Step Width
Time frame: Change between baseline and 1-year post-stroke
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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. This study is not recruiting at the moment.
Dorian Kay Rose, PhD MS BS principal investigator
North Florida/South Georgia Veterans Health System, Gainesville, FL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Backward Walking Training in people with Stroke, run by VA Office of Research and Development 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 8 inclusion and 28 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: finished, as of the sponsor's last update on 24 Nov 2023. 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?
Yes. Results are posted in the registry (first posted 24 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Fall Incidence (Number of Falls) (time frame: Number of recorded falls between baseline and 1-year post-stroke). 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 24 Nov 2023.