Fall Risk Intervention for Stroke (FRISKI)

MGH Institute of Health Professions

Status: Begins enrollment in 1 month

Conditions: Stroke

Treatments: Behavioral: Active Control; Behavioral: Fall Prevention Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT07349030

26AIREA1576341

Details and patient eligibility

About

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, we will provide extra treatment that focuses on helping them not to fall. We will also teach the patients to understand risks for falls and how to avoid them. When they leave the hospital, we will send them a text message every day to ask if they have had any falls. Our 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 us know how we can help people with stroke live longer, healthier lives.

Full 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. We 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. We 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. We 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 our 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.

Enrollment: 134 estimated patients

Sex: All

Ages: 45 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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134 participants in 2 patient groups

Fall Prevention Rehabilitation

Experimental group

Description:

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.

Treatment:

Behavioral: Fall Prevention Intervention

Dose-controlled Active Control

Active Comparator group

Description:

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.

Treatment:

Behavioral: Active Control