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

Flint Rehabilitation Devices

Status: Enrolling

Conditions: Dementia, Mild; Cognitive Dysfunction

Treatments: Other: Conventional exercise program; Device: FitMi AD

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05504811

2R44AG063651-02

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Experimental: FitMi AD Exercise Program

Experimental group

Description:

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.

Treatment:

Device: FitMi AD

Active Comparator: Conventional booklet of exercise program

Active Comparator group

Description:

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.

Treatment:

Other: Conventional exercise program