StrokeFRISKINCT07349030
Fall Risk Intervention for Stroke
A study testing Fall Prevention Intervention in people with Stroke, run by MGH Institute of Health Professions at 1 site in United States.
Trial summary
After stroke, falling is a common problem. Falls can lead to injury, as well as fear of future falls. It is important to try to prevent falls from happening after stroke. To goal of this study is to test a new treatment to try to prevent falls after stroke. Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Stroke
- What is being tested?
- Fall Prevention Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Apr 2026to 31 Dec 2027
- 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 45 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inpatient rehabilitation admission for diagnosis of stroke
- Test positive for fall risk at admission (step-test and obstacle-test, "STOB", >/= 3 out of 8 and/or Berg Balance Scale </=43)
- No pre-stroke history of falls
- Community dwelling and independent in basic and instrumental activities of daily living prior to stroke
- Able to follow 1-step verbal command and demonstrate comprehension and decision-making capacity to consent to study participation
- Able to stand upright for 10 seconds with assistance of no more than one person
Who cannot join
- Brain hemorrhage due to trauma
- Prior stroke with residual physical or cognitive impairment
- Use of assistive device for ambulation prior to stroke
- Diagnosed with dementia
- Receptive or global aphasia
- Receiving chemotherapy in last 6 months or any cancer diagnosis with brain metastases
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Meaghan Costello, DPT contact
United States1 site, 1 recruiting
- Recruiting
Spaulding Rehabilitation Hospital
Boston, Massachusetts, 02129
Megan Schliep, PhD, 507-259-1433, mschliep@mghihp.edu
About this study
Official title: Data-driven Intervention to Reduce Pre-discharge Fall Risk After Stroke
After stroke, falling is a common problem. Falls can lead to injury, as well as fear of future falls. It is important to try to prevent falls from happening after stroke. To goal of this study is to test a new treatment to try to prevent falls after stroke. The people in the study will be patients who are in the hospital receiving care after a stroke. While they are in the hospital, the investigators will provide extra treatment that focuses on helping them not to fall. The investigators will also teach the patients to understand risks for falls and how to avoid them. When they leave the hospital, participants will be sent a text message every day to ask if they have had any falls. The goal is to see if patients who received the extra therapy have fewer falls than patients who did not receive the therapy and education to help avoid falls. If the extra treatment in the hospital can help stop people from falling after they leave the hospital, this will have a positive impact on their lives. By not falling, they will avoid the risk of injury and having to go back to the hospital. This project will help the investigators know how to help people with stroke live longer, healthier lives.
Read the detailed description
Falls are one of the most significant problems for stroke survivors, often resulting in injury, fracture, rehospitalization, recurrent falls, fear of falling, avoidance of physical activity, and subsequent restricted social participation. The rate of falls among stroke survivors is exceptionally high, especially in the first 1-3 months after discharge home from the hospital. The high rate of early post-stroke falls occurs despite intensive inpatient rehabilitation and ongoing rehabilitation after hospital discharge. The central hypothesis to be tested in this study is that a personalized fall prevention intervention provided during inpatient rehabilitation will reduce fall risk before discharge compared to the control intervention (usual care plus dose-matched placebo activity) and reduce the 30-day and 90-day post-discharge fall rates. The study will examine whether a targeted fall prevention intervention delivered during inpatient rehabilitation, in addition to usual care, can reduce fall risk classified by the clinical standard, Berg Balance Scale, at the time of discharge, more than usual care with dose-matched placebo activity (Aim 1). Upon admission to inpatient rehabilitation for stroke, patients without a prior history of falls who test positive for high fall risk using a validated, concise, bedside fall-risk assessment will be randomized 1:1 to experimental and control groups. The investigators will compare differences between groups in the proportion that test positive for fall risk at discharge and the proportion who are discharged to a skilled nursing facility instead of home. Following hospital discharge, falls will be tracked via a daily text message survey for 90 days. The investigators will compare the 30-day and 90-day fall rates between the experimental and control groups (Aim 2). There is a critical need to improve rehabilitation practices for fall prevention early after stroke within current length-of-stay constraints. This study will determine whether an intensive, data-driven fall prevention intervention during inpatient rehabilitation can improve early post-stroke mobility and fall-related outcomes.
- Conditions
- Stroke
- Being tested
- Fall Prevention Intervention, Active Control
- Keywords
- falls, mobility, rehabilitation, physical therapy, physiotherapy, occupational therapy, speech language therapy
- Medical subject headings
- Stroke, Communication Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fall Prevention InterventionBehavioural
The fall prevention rehabilitation program will be provided by a licensed physical therapist and will target modifiable fall risk factors known to be associated with future fall risk after inpatient rehabilitation for stroke. The intervention will be personalized to the individual's fall risk profile at admission. Participants will be educated about physical, cognitive/attentional, and environmental factors associated with falls.
Active ControlBehavioural
The control intervention will not include any of the key ingredients in the experimental intervention. The activities will not target known modifiable factors for fall risk, but the treatment will be a skilled therapy by a licensed provider, matching the dose of the experimental intervention. Participants in the control group will receive education about stroke, stroke recovery, stroke prevention, wellness, and community support groups.
| Study group | Role | What they receive |
|---|---|---|
| Fall Prevention Rehabilitation | Experimental | In addition to usual care, participants randomized to the experimental intervention will receive 30-minute sessions of rehabilitation 6 times a week during the first week and 3 times a week thereafter until discharge. The intervention will target fall risk factors that are specific to the individual's fall risk profile at hospital admission. Patient and family education on fall prevention is also included. Receives: Behavioral: Fall Prevention Intervention |
| Dose-controlled Active Control | Active comparator | In addition to usual care, participants randomized to the control intervention will receive 30-minute sessions of active control rehabilitation 6 times a week during the first week and 3 times a week thereafter until discharge. The intervention will be skilled rehabilitation that does not target known fall risk factors. Education on stroke recovery and stroke prevention will be provided as part of the control intervention. Receives: Behavioral: Active Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg Balance Scale
Proportion of participants in each group who are at fall risk at hospital discharge, determined by the Berg Balance Scale (where fall risk is indicated by a score </= 43 out of 56).
Measured: Immediately post intervention
Fall Rate
Prevalence of fallers (one or more falls) in each group 30 days after discharge
Measured: 30-days post intervention
Fall Rate
Prevalence of fallers (one or more falls) in each group 90 days after discharge
Measured: 90 days post intervention
Secondary outcomes (3)
Functional Gait Assessment
Proportion of participants in each group who are at fall risk at discharge, determined by the Functional Gait Assessment (where fall risk is indicated by a score </= 13 out of 30).
Measured: Immediately post intervention
Step-Obstacle Test
Proportion of participants in each group who are at fall risk at discharge, determined by the Step-Obstacle test combination (where fall risk is indicated by a score >/= 3 out of 8).
Measured: Immediately post intervention
Discharge Disposition
Location discharged to from rehabilitation hospital
Measured: Immediately post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start9 Apr 2026
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MGH Institute of Health Professions
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prudence Plummer, MGH Institute of Health Professions
- Investigators
- Prudence Plummer, PhD, Principal investigator, MGH Institute of Health Professions
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07349030
- Sponsor's protocol ID
- 26AIREA1576341
- Acronym
- FRISKI
- Status last verified
- Jun 2026
- First submitted
- 29 Dec 2025
- Last updated
- 3 Jun 2026
- Results posted
- No
- 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 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Data-driven Intervention to Reduce Pre-discharge Fall Risk After Stroke
- ClinicalTrials.gov ID
- NCT07349030
- Acronym / sponsor ID
- FRISKI / 26AIREA1576341
- Conditions
- Stroke
- Keywords
- falls, mobility, rehabilitation, physical therapy, physiotherapy, occupational therapy, speech language therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- MGH Institute of Health ProfessionsUniversity, hospital or other
- Study start
- 9 Apr 2026 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 16 Jan 2026 (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.
After stroke, falling is a common problem. Falls can lead to injury, as well as fear of future falls. It is important to try to prevent falls from happening after stroke. To goal of this study is to test a new treatment to try to prevent falls after stroke. The people in the study will be patients who are in the hospital receiving care after a stroke. While they are in the hospital, the investigators will provide extra treatment that focuses on helping them not to fall. The investigators will also teach the patients to understand risks for falls and how to avoid them. When they leave the hospital, participants will be sent a text message every day to ask if they have had any falls. The goal is to see if patients who received the extra therapy have fewer falls than patients who did not receive the therapy and education to help avoid falls. If the extra treatment in the hospital can help stop people from falling after they leave the hospital, this will have a positive impact on their lives. By not falling, they will avoid the risk of injury and having to go back to the hospital. This project will help the investigators know how to help people with stroke live longer, healthier lives.
Detailed description
Falls are one of the most significant problems for stroke survivors, often resulting in injury, fracture, rehospitalization, recurrent falls, fear of falling, avoidance of physical activity, and subsequent restricted social participation. The rate of falls among stroke survivors is exceptionally high, especially in the first 1-3 months after discharge home from the hospital. The high rate of early post-stroke falls occurs despite intensive inpatient rehabilitation and ongoing rehabilitation after hospital discharge. The central hypothesis to be tested in this study is that a personalized fall prevention intervention provided during inpatient rehabilitation will reduce fall risk before discharge compared to the control intervention (usual care plus dose-matched placebo activity) and reduce the 30-day and 90-day post-discharge fall rates. The study will examine whether a targeted fall prevention intervention delivered during inpatient rehabilitation, in addition to usual care, can reduce fall risk classified by the clinical standard, Berg Balance Scale, at the time of discharge, more than usual care with dose-matched placebo activity (Aim 1). Upon admission to inpatient rehabilitation for stroke, patients without a prior history of falls who test positive for high fall risk using a validated, concise, bedside fall-risk assessment will be randomized 1:1 to experimental and control groups. The investigators will compare differences between groups in the proportion that test positive for fall risk at discharge and the proportion who are discharged to a skilled nursing facility instead of home. Following hospital discharge, falls will be tracked via a daily text message survey for 90 days. The investigators will compare the 30-day and 90-day fall rates between the experimental and control groups (Aim 2). There is a critical need to improve rehabilitation practices for fall prevention early after stroke within current length-of-stay constraints. This study will determine whether an intensive, data-driven fall prevention intervention during inpatient rehabilitation can improve early post-stroke mobility and fall-related outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fall Prevention Rehabilitation | Experimental | Behavioral: Fall Prevention InterventionIn addition to usual care, participants randomized to the experimental intervention will receive 30-minute sessions of rehabilitation 6 times a week during the first week and 3 times a week thereafter until discharge. The intervention will target fall risk factors that are specific to the individual's fall risk profile at hospital admission. Patient and family education on fall prevention is also included. |
| Dose-controlled Active Control | Active comparator | Behavioral: Active ControlIn addition to usual care, participants randomized to the control intervention will receive 30-minute sessions of active control rehabilitation 6 times a week during the first week and 3 times a week thereafter until discharge. The intervention will be skilled rehabilitation that does not target known fall risk factors. Education on stroke recovery and stroke prevention will be provided as part of the control intervention. |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Inpatient rehabilitation admission for diagnosis of stroke
- Test positive for fall risk at admission (step-test and obstacle-test, "STOB", >/= 3 out of 8 and/or Berg Balance Scale </=43)
- No pre-stroke history of falls
- Community dwelling and independent in basic and instrumental activities of daily living prior to stroke
- Able to follow 1-step verbal command and demonstrate comprehension and decision-making capacity to consent to study participation
Key exclusion criteria (6 listed)
- Brain hemorrhage due to trauma
- Prior stroke with residual physical or cognitive impairment
- Use of assistive device for ambulation prior to stroke
- Diagnosed with dementia
- Receptive or global aphasia
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 |
|---|---|---|
| Fall Prevention InterventionThe fall prevention rehabilitation program will be provided by a licensed physical therapist and will target modifiable fall risk factors known to be associated with future fall risk after inpatient rehabilitation for stroke. The intervention will be personalized to the individual's fall risk profile at admission. Participants will be educated about physical, cognitive/attentional, and environmental factors associated with falls. | Behavioural | Fall Prevention Rehabilitation |
| Active ControlThe control intervention will not include any of the key ingredients in the experimental intervention. The activities will not target known modifiable factors for fall risk, but the treatment will be a skilled therapy by a licensed provider, matching the dose of the experimental intervention. Participants in the control group will receive education about stroke, stroke recovery, stroke prevention, wellness, and community support groups. | Behavioural | Dose-controlled Active Control |
Primary outcome
Berg Balance Scale
Time frame: Immediately post intervention
Proportion of participants in each group who are at fall risk at hospital discharge, determined by the Berg Balance Scale (where fall risk is indicated by a score </= 43 out of 56).
Fall Rate
Time frame: 30-days post intervention
Prevalence of fallers (one or more falls) in each group 30 days after discharge
Fall Rate
Time frame: 90 days post intervention
Prevalence of fallers (one or more falls) in each group 90 days after discharge
3 secondary outcomes
Functional Gait Assessment
Time frame: Immediately post intervention
Step-Obstacle Test
Time frame: Immediately post intervention
Discharge Disposition
Time frame: Immediately post intervention
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 3 Jun 2026.
- 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.
Meaghan Costello, DPT contact
Prudence Plummer, PhD principal investigator
MGH Institute of Health Professions
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fall Prevention Intervention in people with Stroke, run by MGH Institute of Health Professions 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 6 inclusion and 6 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 3 Jun 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 Prudence Plummer, PhD (617-724-3103, pplummer@mghihp.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Berg Balance Scale (time frame: Immediately post intervention). The study lists 3 primary outcomes in all. 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 3 Jun 2026; AzTrials last refreshed its copy on 31 Oct 2026.