Fall Risk Intervention for Stroke

Official title

Data-driven Intervention to Reduce Pre-discharge Fall Risk After Stroke

Overview

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.

Interventions

• 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.
• 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.

Primary outcome measures

• Berg Balance Scale [Time frame: Immediately post intervention]
• Fall Rate [Time frame: 30-days post intervention]
• Fall Rate [Time frame: 90 days post intervention]

Secondary outcome measures (3)

• Functional Gait Assessment [Time frame: Immediately post intervention]
• Step-Obstacle Test [Time frame: Immediately post intervention]
• Discharge Disposition [Time frame: Immediately post intervention]

Eligibility criteria

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 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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 1 center

• Spaulding Rehabilitation Hospital — Boston

Identifiers

NCT: NCT07349030 · 26AIREA1576341

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗