FitMi AD Home Therapy for Alzheimer's Disease

Recruiting in Palo Alto (17 mi)

Overseen byFreddi Segal-Gidan, PA, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Flint Rehabilitation Devices, LLC

Disqualifiers: Wheelchair use, Neurologic conditions, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Freddi Segal-Gidan, PA, PhD

Principal Investigator

Rancho Research Institute, Inc.

Eligibility Criteria

This trial is for individuals over 50 with mild cognitive impairment or mild dementia due to Alzheimer's, who can see and hear well enough to follow on-screen instructions. They must have support from someone who knows about their daily living skills.

Inclusion Criteria

I can see clearly and hear well.

Have a family member or friend who can answer questions about the participant's daily living skills

Willing to participate in a research study

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Exclusion Criteria

Presence of other severe concurrent medical conditions that may prevent the participants from completing the 3-month study

I have a neurological condition like a movement disorder or a history of stroke.

I am under 50 years old.

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Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants perform exercises using either the FitMi AD device or a conventional exercise booklet for 3 months

12 weeks

Daily home exercises

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

Conventional exercise program (Behavioural Intervention)
FitMi AD Home Therapy (Procedure)

Trial OverviewThe study tests a new exercise device called FitMi AD against conventional exercises. FitMi AD tracks movements during computer-guided exercises designed for those with cognitive impairments.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Experimental: FitMi AD Exercise ProgramExperimental Treatment1 Intervention

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 II: Active Comparator: Conventional booklet of exercise programActive Control1 Intervention

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.