Fall Risk Intervention for Stroke (FRISKI)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Stroke
• Intervention / Treatment: Behavioral: Fall Prevention Intervention; Behavioral: Active Control

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 Type: Interventional
• Enrollment (Estimated): 134
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Prudence Plummer, PhD; Phone Number: 617-724-3103; Email: pplummer@mghihp.edu
• Study Contact Backup: Name: Meaghan Costello, DPT; Email: mcostello4@mgb.org

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02129
      • Spaulding Rehabilitation Hospital
      • Contact: Megan Schliep, PhD; Phone Number: 507-259-1433; Email: mschliep@mghihp.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Inpatient rehabilitation admission for diagnosis of stroke
• Test positive for fall risk at admission (step-test and obstacle-test, "STOB", >/= 3 out of 8)
• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fall Prevention Rehabilitation; 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.	Behavioral: Fall Prevention Intervention; 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 Comparator: Dose-controlled Active Control; 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.	Behavioral: Active Control; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Immediately post intervention
Fall Rate	Prevalence of fallers (one or more falls) in each group 30 days after discharge	30-days post intervention
Fall Rate	Prevalence of fallers (one or more falls) in each group 90 days after discharge	90 days post intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	Immediately post intervention
Discharge Disposition	Location discharged to from rehabilitation hospital	Immediately post intervention

Collaborators and Investigators

• Sponsor: MGH Institute of Health Professions
• Investigators: Principal Investigator: Prudence Plummer, PhD, MGH Institute of Health Professions

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: December 29, 2025
• First Submitted That Met QC Criteria: January 10, 2026
• First Posted (Actual): January 16, 2026

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 25, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: rehabilitation; falls; physiotherapy; mobility; physical therapy; occupational therapy; speech language therapy
• Additional Relevant MeSH Terms: Neurologic Manifestations; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Mental Disorders; Neurobehavioral Manifestations; Neurodevelopmental Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Stroke; Communication Disorders
• Other Study ID Numbers: 26AIREA1576341

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No