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临床试验/NCT07349030
NCT07349030招募中不适用

Data-driven Intervention to Reduce Pre-discharge Fall Risk After Stroke

MGH Institute of Health Professions1 个研究点 分布在 1 个国家目标入组 134 人开始时间: 2026年4月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
134
试验地点
1
主要终点
Berg Balance Scale

研究概览

简要总结

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.

详细描述

Falls are one of the most significant problems for stroke survivors, often resulting in injury, fracture, rehospitalization, recurrent falls, fear of falling, avoidance of physical activity, and subsequent restricted social participation. The rate of falls among stroke survivors is exceptionally high, especially in the first 1-3 months after discharge home from the hospital. The high rate of early post-stroke falls occurs despite intensive inpatient rehabilitation and ongoing rehabilitation after hospital discharge. The central hypothesis to be tested in this study is that a personalized fall prevention intervention provided during inpatient rehabilitation will reduce fall risk before discharge compared to the control intervention (usual care plus dose-matched placebo activity) and reduce the 30-day and 90-day post-discharge fall rates. The study will examine whether a targeted fall prevention intervention delivered during inpatient rehabilitation, in addition to usual care, can reduce fall risk classified by the clinical standard, Berg Balance Scale, at the time of discharge, more than usual care with dose-matched placebo activity (Aim 1). Upon admission to inpatient rehabilitation for stroke, patients without a prior history of falls who test positive for high fall risk using a validated, concise, bedside fall-risk assessment will be randomized 1:1 to experimental and control groups. The investigators will compare differences between groups in the proportion that test positive for fall risk at discharge and the proportion who are discharged to a skilled nursing facility instead of home. Following hospital discharge, falls will be tracked via a daily text message survey for 90 days. The investigators will compare the 30-day and 90-day fall rates between the experimental and control groups (Aim 2). There is a critical need to improve rehabilitation practices for fall prevention early after stroke within current length-of-stay constraints. This study will determine whether an intensive, data-driven fall prevention intervention during inpatient rehabilitation can improve early post-stroke mobility and fall-related outcomes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
45 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

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.

干预措施: Fall Prevention Intervention (Behavioral)

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.

干预措施: Active Control (Behavioral)

结局指标

主要结局

Berg Balance Scale

时间窗: Immediately post intervention

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).

Fall Rate

时间窗: 30-days post intervention

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

Fall Rate

时间窗: 90 days post intervention

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

次要结局

  • Functional Gait Assessment(Immediately post intervention)
  • Step-Obstacle Test(Immediately post intervention)
  • Discharge Disposition(Immediately post intervention)

研究者

发起方
MGH Institute of Health Professions
申办方类型
Other
责任方
Principal Investigator
主要研究者

Prudence Plummer

Professor

MGH Institute of Health Professions

研究点 (1)

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