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

Cognitive Dysfunction Clinical Trial

Official title:

FitMi AD: a Safe and Motivating Computer-guided Exercise System for Individuals With MCI or Mild Dementia Due to Alzheimer's Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05504811
• Other study ID #: 2R44AG063651-02
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: April 10, 2024

Study information

• Verified date: September 2023
• Source: Flint Rehabilitation Devices, LLC
• Contact: Daniel Zondervan, PhD
• Phone: 949-313-7322
• Email: dzondervan[@]flintrehab.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: April 10, 2024
• Est. primary completion date: April 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Dysfunction
• Dementia
• Dementia, Mild

Intervention

Device:
• FitMi AD
Exercise using the motion sensing devices and a tablet computer

Other:
• Conventional exercise program
Exercise following printed sheets or booklet

Locations

Country	Name	City	State
United States	Rancho Research Institute, Inc	Downey	California

Sponsors (2)

Lead Sponsor	Collaborator
Flint Rehabilitation Devices, LLC	Rancho Research Institute, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	Visual Analog Pain Scale	Indicates perceived pain intensity. The scale consists of a line, often 10 cm long, with verbal anchors at either end (i.e. "no pain" on the far left and "the most intense pain imaginable" on the far right). The patient places a mark at a point on the line corresponding to the patient's rating of pain intensity.	Baseline, Immediately Post-Treatment (an average of 3 months)
Secondary	Global Physical Activity Questionnaire	Assesses physical activity habits	Baseline, Immediately Post-Treatment (an average of 3 months)
Secondary	Geriatric Depression Scale	Evaluates depression in elderly individuals. Scores of 0-4 are considered normal, depending on age, education, and complaints; 5-8 indicate mild depression; 9-11 indicate moderate depression; and 12-15 indicate severe depression.	Baseline, Immediately Post-Treatment (an average of 3 months)
Secondary	Pittsburgh Sleep Quality Index	Measures the quality and patterns of sleep in adults. Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality.	Baseline, Immediately Post-Treatment (an average of 3 months)
Secondary	Duration of exercise performed	Duration of exercise performed over intervention period.	Immediately Post-Treatment (an average of 3 months)