Fall Prevention for Stroke

(FRISKI Trial)

PP
MC
Overseen ByMeaghan Costello, DPT
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: MGH Institute of Health Professions
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help people who have had a stroke avoid falls, which are common and can lead to injuries. Participants will receive extra therapy in the hospital focused on fall prevention and education about avoiding falls. After leaving the hospital, they will receive daily text messages to report any falls, helping researchers determine if the extra therapy reduces falls. Ideal participants are those recovering from a stroke in the hospital, who can stand with some help and were independent in daily activities before their stroke.

As an unphased trial, this study offers participants the opportunity to contribute to important research that could improve fall prevention strategies for stroke survivors.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this fall prevention intervention is safe for stroke patients?

Research has shown that fall prevention treatments for stroke patients are generally safe. One study found that exercises and education can help reduce falls in these patients. No strong evidence suggests that these methods cause harm. Another source highlights the importance of teaching patients about risks and how to avoid them as part of their care. These strategies are well-tolerated, with no significant reports of serious side effects. Overall, treatments to prevent falls are considered safe for stroke patients.12345

Why are researchers excited about this trial?

Researchers are excited about the Fall Prevention Intervention for stroke patients because it takes a personalized approach to reducing fall risks. Unlike standard rehabilitation, which generally focuses on overall recovery, this intervention zeroes in on individual fall risk factors identified at hospital admission. Additionally, it incorporates patient and family education specifically about fall prevention, which is not typically emphasized in traditional care. This tailored strategy aims to make fall prevention more effective and relevant for each patient, potentially reducing falls significantly during recovery.

What evidence suggests that this trial's treatments could be effective for fall prevention after stroke?

Research has shown that preventing falls after a stroke presents a significant challenge. One review found that exercise alone might not sufficiently reduce falls in stroke patients. However, addressing specific risk factors for falls and educating patients can be more effective. This trial will compare two approaches: Fall Prevention Rehabilitation, which targets individual fall risk factors, and a Dose-controlled Active Control, which provides skilled rehabilitation without targeting fall risk factors. Studies highlight that understanding each person's risk factors can help create better fall prevention strategies. This approach aims to lower the risk of injuries and hospital visits after a stroke by addressing individual needs. While more research is needed, early signs suggest that personalized fall prevention plans could make a real difference.12346

Who Is on the Research Team?

PP

Prudence Plummer, PhD

Principal Investigator

MGH Institute of Health Professions

Are You a Good Fit for This Trial?

This trial is for hospital patients who have recently had a stroke. It aims to help them avoid falls, which are common and risky after a stroke. To join, participants must be currently hospitalized for stroke care.

Inclusion Criteria

I was living at home and could take care of myself before my stroke.
I can stand up with help from one person for at least 10 seconds.
I am admitted for stroke rehabilitation.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week
1 visit (in-person)

Inpatient Rehabilitation

Participants receive personalized fall prevention intervention or active control rehabilitation during inpatient stay

2-4 weeks
Daily sessions (in-person)

Post-Discharge Monitoring

Participants are monitored for fall occurrences via daily text message survey

90 days
Daily text messages

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Fall Prevention Intervention

Trial Overview

The study tests a fall prevention intervention against an active control group. Patients receive extra therapy focused on fall avoidance while in the hospital and follow-up text messages checking for falls post-discharge.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Fall Prevention RehabilitationExperimental Treatment1 Intervention
Group II: Dose-controlled Active ControlActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

MGH Institute of Health Professions

Lead Sponsor

Trials
19
Recruited
2,200+

Citations

Interventions for preventing falls in people after stroke - PMC

The review authors included evidence up to November 2012 and found insufficient evidence that administration of exercise reduces falling in people after stroke.

NCT07349030 | Fall Risk Intervention for Stroke

This study will determine whether an intensive, data-driven fall prevention intervention during inpatient rehabilitation can improve early post- ...

Falls in Stroke Patients Occurred Not Only in Those at a ...

A total of 1179 falls were observed among 213,503 person-days during the entire hospitalization period, with an average fall rate of 5.5/1000 person-days. The ...

A Systematic Review of Fall Risk Factors in Stroke Survivors

This study provides an evidence-based methodology to identify the relevant risk factors, as well as their commonalities and trends.

Redesigned Fall and Injury Management of Patients With ...

The purpose of this article is to provide an overview of the selected evidence that supports redesign of fall prevention management of patients with stroke.

Rehabilitation and Recovery following Stroke Evidence ...

Recommend that fall prevention precautions be implemented for all patients identified to be at risk for falls while they are in the hospital. Refer to the falls ...