Fall Risk Intervention for Stroke

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
MGH Institute of Health Professions
Study ID
NCT07349030
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
45 Years - 85 Years
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Apr 9, 2026
Status verified
Jun 2026
Primary completion
Oct 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
134 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Fall Prevention Rehabilitation
    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.
  • Active Comparator: Dose-controlled Active Control
    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.

Primary Outcome Measure

Berg Balance Scale [ Time Frame: Immediately post intervention ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Spaulding Rehabilitation HospitalBostonMassachusetts02129
Megan Schliep, PhD
[email protected]
507-259-1433

Find similar trials in Boston, MA

By condition
Stroke
By specialty
NeurologyBrain disorders
By research site
Spaulding Rehabilitation Hospital· Boston, MA

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