Recruiting

Fall Prevention

Sponsor:

MGH Institute of Health Professions

Code:

NCT07349030

Conditions

Stroke

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Not accepted

Interventions

Fall Prevention Intervention

Active Control

Study Details

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

Study ID

NCT07349030

Start date

Apr 9, 2026

Status verified date

Jun, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Oct 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

134 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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.

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 measure

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

Central Contacts and Locations

Central contacts

Prudence Plummer, PhD

617-724-3103pplummer@mghihp.edu

Meaghan Costello, DPT

mcostello4@mgb.org

Locations

Spaulding Rehabilitation Hospital

Recruiting

Boston, Massachusetts, United States, 02129

Contacts

Megan Schliep, PhD

507-259-1433mschliep@mghihp.edu

More Information

Sponsor

MGH Institute of Health Professions

Last update posted

Jun 3, 2026

Last verified

Jun, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by MGH Institute of Health Professions on 2026-06-03.