Home therapy using FitMi AD for people with mild dementia or cognitive impairment
FitMi AD: a Safe and Motivating Computer-guided Exercise System for Individuals with MCI or Mild Dementia Due to Alzheimer's Disease
This study tests if using the FitMi AD exercise device can help people with mild dementia or cognitive impairment improve their thinking skills and stay active better than regular exercise programs.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | Flint Rehabilitation Devices, LLC Industry-sponsored |
| Locations | 1 site (Downey, California) |
| Trial ID | NCT05504811 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of the FitMi AD exercise device for individuals with mild cognitive impairment (MCI) or mild dementia due to Alzheimer's disease. The device features embedded sensors that track and record the patient's movements while they perform exercises displayed on a tablet. Participants will engage in a 3-month program comparing the FitMi AD to a conventional exercise program. The goal is to assess improvements in cognitive function and physical activity levels.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 50 and older with a diagnosis of MCI or mild dementia due to Alzheimer's disease.
Not a fit: Patients with severe concurrent medical conditions or other neurologic disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could enhance cognitive function and physical activity in patients with mild dementia or MCI.
How similar studies have performed: Other studies have shown promise in using technology-assisted exercise programs for cognitive improvement, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Downey, California
- Rancho Research Institute, Inc — Downey, California, United States (Recruiting)
Study contacts
- Principal investigator: Freddi Segal-Gidan, PA, PhD — Rancho Research Institute, Inc.
- Study coordinator: Daniel Zondervan, PhD
- Email: dzondervan@flintrehab.com
- Phone: 949-313-7322
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.