Fall Prevention in Mild Cognitive Impairment | NCT07507812

Studies
Fall Prevention in Mild Cognitive Impairment

NCT07507812

Sponsor

VA Office of Research and Development

Status

Not yet recruiting

Last Update Posted

Apr 9, 2026Actual

Enrollment

28Estimated

Phase

Not Applicable

Conditions

Cognitive Impairment
High Fall Risk

Interventions

Virtual Neurophysiological Rehabilitation

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
1I21RD000591-01A1	Other Grant/Funding Number	Department of Veterans Affairs

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2027Estimated

Primary Completion Date

Jun 1, 2028Estimated

Completion Date

Jun 1, 2028Estimated

First Submitted Date

Mar 27, 2026

First Submission Date that Met QC Criteria

Mar 27, 2026

First Posted Date

Apr 2, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 3, 2026

Last Update Posted Date

Apr 9, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

28Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group	Experimental	There will be no group assignments in this pilot study and all participants will receive the intervention.	Behavioral: Virtual Neurophysiological Rehabilitation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Virtual Neurophysiological Rehabilitation	Behavioral	Combining active observation (AO) and motor imagery (MI)	Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Program Adherence	Number of sessions attended	6 weeks

Secondary Outcomes

Measure	Description	Time Frame
Change in Four Square Step Test time	Time to complete the Four Square Step Test	6 weeks
Change in 30 second chair stand test	Number of unassisted chair rises completed in 30 seconds

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Alyssa D Stookey, PhD MS	Contact	(410) 605-7000	5431	alyssa.stookey@va.gov
Odessa R Addison, PhD DPT	Contact	(410) 605-7000	5393	Odessa.Addison@va.gov

Overall Officials

Name	Affiliation	Role
Alyssa D Stookey, PhD MS	Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD		Baltimore	Maryland	21201	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D060825	Cognitive Dysfunction

Ancestor Terms

ID	Term
D003072	Cognition Disorders
D019965	Neurocognitive Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided