Health TrialsbyHealthPanel

Fall Risk Intervention for Stroke

ConditionStroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-85
SponsorMGH Institute of Health Professions

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

134 Participants
are divided into 2 treatment groups
Group A: Fall Prevention RehabilitationExperimental treatment 1 intervention
Group B: Dose-controlled Active ControlActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
Immediately post intervention
2

Fall Rate

Prevalence of fallers (one or more falls) in each group 30 days after discharge

Time frame
30-days post intervention
3

Fall Rate

Prevalence of fallers (one or more falls) in each group 90 days after discharge

Time frame
90 days post intervention

Secondary outcomes

1

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).

Time frame
Immediately post intervention
2

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).

Time frame
Immediately post intervention
3

Discharge Disposition

Location discharged to from rehabilitation hospital

Time frame
Immediately post intervention

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

MGH Institute of Health Professions

Lead sponsor

Source ClinicalTrials.gov
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