Fall Risk Intervention for Stroke

NCT07349030 | Not Yet Recruiting

• 1 other identifier: 26AIREA1576341
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Stroke

Keywords

falls; mobility; rehabilitation; physical therapy; physiotherapy; occupational therapy; speech language therapy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Functional Gait Assessment

  Immediately post intervention

• Step-Obstacle Test

  Immediately post intervention

• Discharge Disposition

  Immediately post intervention

Study Arms (2)

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.

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.

Behavioral: Active Control

Interventions

Fall Prevention Intervention BEHAVIORAL

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.

Fall Prevention Rehabilitation

Active Control BEHAVIORAL

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.

Dose-controlled Active Control

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MGH Institute of Health Professions: lead

Study Sites (1)

Spaulding Rehabilitation Hospital

Boston, Massachusetts, 02129, United States

Location

MeSH Terms

Conditions

Stroke; Communication Disorders

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Prudence Plummer, PhD

  MGH Institute of Health Professions

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Prudence Plummer, PhD

CONTACT

617-724-3103; pplummer@mghihp.edu

Meaghan Costello, DPT

CONTACT

mcostello4@mgb.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 29, 2025
• First Posted: January 16, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)