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

NCT05504811 | Completed FDA Device

• 1 other identifier: 2R44AG063651-02
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cognitive Dysfunction; Dementia, Mild

Outcome Measures

Primary Outcomes (3)

• Change in Functional Reach Test

  How far can someone reach while standing in a fixed position

  Baseline, Immediately Post-Treatment (an average of 3 months)

• Change in Timed Up and Go test

  Time it takes to stand up from a chair and walk a short distance

  Baseline, Immediately Post-Treatment (an average of 3 months)

• Change in 30 second chair stand test

  How many times someone stand up from a chair in 30 seconds

  Baseline, Immediately Post-Treatment (an average of 3 months)

Secondary Outcomes (5)

• Visual Analog Pain Scale

  Baseline, Immediately Post-Treatment (an average of 3 months)

• Global Physical Activity Questionnaire

  Baseline, Immediately Post-Treatment (an average of 3 months)

• Geriatric Depression Scale

  Baseline, Immediately Post-Treatment (an average of 3 months)

• Pittsburgh Sleep Quality Index

  Baseline, Immediately Post-Treatment (an average of 3 months)

• Duration of exercise performed

  Immediately Post-Treatment (an average of 3 months)

Study Arms (2)

Experimental: FitMi AD Exercise Program

EXPERIMENTAL

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.

Device: FitMi AD

Active Comparator: Conventional booklet of exercise program

ACTIVE COMPARATOR

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.

Other: Conventional exercise program

Interventions

FitMi AD DEVICE

Exercise using the motion sensing devices and a tablet computer

Experimental: FitMi AD Exercise Program

Conventional exercise program OTHER

Exercise following printed sheets or booklet

Active Comparator: Conventional booklet of exercise program

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Flint Rehabilitation Devices, LLC: lead
• Rancho Research Institute, Inc.: collaborator

Study Sites (1)

Rancho Research Institute, Inc

Downey, California, 90242, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Dementia; Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Freddi Segal-Gidan, PA, PhD

  Rancho Research Institute, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single (Outcomes Assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2022
• First Posted: August 17, 2022
• Study Start: September 8, 2023
• Primary Completion: March 12, 2025
• Study Completion: March 12, 2025
• Last Updated: December 24, 2025

Record last verified: 2024-09

Locations

US (1)