FitMi AD Home Therapy for Individuals With MCI or Mild Dementia Due to Alzheimer's Disease

NCT ID: NCT05504811

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-08

Study Completion Date

2025-03-12

Brief Summary

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This study will investigate the efficacy of a newly developed exercise device (FitMi AD) for individuals with mild cognitive impairment (MCI) or mild dementia due to Alzheimer's disease. FitMi AD uses embedded sensors that can track and record the patient's direction and degree of movement while performing exercises described on a computer.

Detailed Description

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Conditions

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Cognitive Dysfunction Dementia, Mild

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Single (Outcomes Assessor)

Study Groups

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Experimental: FitMi AD Exercise Program

Participants will perform exercises by interacting with FitMi pucks, as described and monitored on a tablet computer. Participants will be asked to exercise at least 30 minutes per day for 3 months.

Group Type EXPERIMENTAL

FitMi AD

Intervention Type DEVICE

Exercise using the motion sensing devices and a tablet computer

Active Comparator: Conventional booklet of exercise program

Participants will perform exercises described in a booklet similar to what is typically provided to individuals. Participants will be asked to exercise at least 30 minutes per day for 3 months.

Group Type ACTIVE_COMPARATOR

Conventional exercise program

Intervention Type OTHER

Exercise following printed sheets or booklet

Interventions

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FitMi AD

Exercise using the motion sensing devices and a tablet computer

Intervention Type DEVICE

Conventional exercise program

Exercise following printed sheets or booklet

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* have MCI or mild dementia due to AD (i.e. Clinical Dementia Rating (CDR) score 1 for mild dementia or 0.5 for MCI)
* ability to clearly see the screen and hear the audio instructions from the tablet
* have a family member or friend who can answer questions about the participant's daily living skills
* willing to participate in a research study.

Exclusion Criteria

* age \< 50 years old
* use of a wheelchair as a primary mobility device (use of a cane or walker is permitted)
* presence of other neurologic conditions such as movement disorders or history of stroke
* other severe concurrent medical conditions that may prevent the participants from completing the 3-month study
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rancho Research Institute, Inc.

OTHER

Sponsor Role collaborator

Flint Rehabilitation Devices, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Freddi Segal-Gidan, PA, PhD

Role: PRINCIPAL_INVESTIGATOR

Rancho Research Institute, Inc.

Locations

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Rancho Research Institute, Inc

Downey, California, United States

Site Status

Countries

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United States

Other Identifiers

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2R44AG063651-02

Identifier Type: NIH

Identifier Source: org_study_id

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