- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07507812
Fall Prevention in Mild Cognitive Impairment (NEUROFALL)
April 3, 2026 updated by: VA Office of Research and Development
Fall Prevention in Cognitively Impaired Older Veterans Through Neurophysiological Rehabilitation
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Estimated)
28
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Odessa R Addison, PhD DPT
- Phone Number: 5393 (410) 605-7000
- Email: Odessa.Addison@va.gov
Study Contact Backup
- Name: Alyssa D Stookey, PhD MS
- Phone Number: 5431 (410) 605-7000
- Email: alyssa.stookey@va.gov
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21201
- Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
-
Contact:
- Jamie Giffuni, MD BA
- Phone Number: 4840 410-605-7000
- Email: jamie.giffuni@va.gov
-
Principal Investigator:
- Alyssa D Stookey, PhD MS
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group
There will be no group assignments in this pilot study and all participants will receive the intervention.
|
Combining active observation (AO) and motor imagery (MI)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Program Adherence
Time Frame: 6 weeks
|
Number of sessions attended
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Four Square Step Test time
Time Frame: 6 weeks
|
Time to complete the Four Square Step Test
|
6 weeks
|
|
Change in 30 second chair stand test
Time Frame: 6 weeks
|
Number of unassisted chair rises completed in 30 seconds
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Alyssa D Stookey, PhD MS, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
June 1, 2027
Primary Completion (Estimated)
June 1, 2028
Study Completion (Estimated)
June 1, 2028
Study Registration Dates
First Submitted
March 27, 2026
First Submitted That Met QC Criteria
March 27, 2026
First Posted (Actual)
April 2, 2026
Study Record Updates
Last Update Posted (Actual)
April 9, 2026
Last Update Submitted That Met QC Criteria
April 3, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RRD6-001-25M
- 1I21RD000591-01A1 (Other Grant/Funding Number: Department of Veterans Affairs)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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