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Not yet recruiting NCT07507812

Fall Prevention in Mild Cognitive Impairment

No phase Interventional Cognitive Impairment High Fall Risk

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Virtual Neurophysiological Rehabilitation.
Who it may be relevant to
Registry conditions: Cognitive Impairment, High Fall Risk. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Fall Prevention in Cognitively Impaired Older Veterans Through Neurophysiological Rehabilitation

Overview

Falls represent the leading cause of hospitalization, nursing home admissions, disability and mortality for older adults with annual healthcare costs over $50 billion. Older Veterans with cognitive impairment are at an increased risk of falls and injurious fall. The purpose of this study is to test the effects of 6 weeks of a virtual tele-neurorehabilitation intervention on fall prevention, functional mobility, strength, cognition and performance of activities of daily living. Participants will be one of 28 participants in the VA Maryland Health Care System. Participation in the study is voluntary and the research will be conducted at the VA Maryland Health Care System. The entire study will take approximately 2 years to complete. Subject's participation in the study will last 3 months.

Detailed description

Falls represent the leading cause of hospitalization, nursing home admissions, disability and mortality for older adults with annual healthcare costs over $50 billion. Older Veterans with cognitive impairment are at an increased risk of falls and injurious fall. This pilot aims to determine the feasibility and effectiveness of a virtual neurorehabilitation intervention to improve functional mobility, strength, cognition and performance of activities of daily living in a cohort of 28 older Veterans with cognitive impairment. The overall goals are to improve fall risk in a population for which traditional rehabilitation programs may not be feasible. The investigators envision a neurorehabilitation model that can be readily exportable and widely implemented at other VA facilities with minimal resources as an enhancement to clinical care for fall prevention.

Interventions

  • Behavioral Virtual Neurophysiological Rehabilitation
    Combining active observation (AO) and motor imagery (MI)

Primary outcome measures

  • Program Adherence [Time frame: 6 weeks]
Secondary outcome measures (2)
  • Change in Four Square Step Test time [Time frame: 6 weeks]
  • Change in 30 second chair stand test [Time frame: 6 weeks]

Eligibility criteria

Inclusion criteria

  • community dwelling
  • at risk for falls as indicated by answering yes to one of the following: 1) have you fallen in the last year? 2) four square step test time > 15 seconds 3) are you worried about falling?
  • cognitive impairment as indicated by either 1) clinical diagnosis 2) MOCA score of 10-25
  • able to provide written consent

Exclusion criteria

  • MOCA <10 or clinically diagnosed dementia
  • inability to participate in a virtual intervention
  • serious visual or hearing problems
  • stroke with hemiparesis or severe neurological disease
  • current use of medications affecting mental state
  • current active participation in programs related to balance or mobility

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

United States · 1 center
  • Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD — Baltimore

Identifiers

NCT: NCT07507812 · RRD6-001-25M · 1I21RD000591-01A1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗