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Procedure

FitMi AD Home Therapy for Alzheimer's Disease

N/A
Recruiting
Led By Freddi Segal-Gidan, PA, PhD
Research Sponsored by Flint Rehabilitation Devices, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have MCI or mild dementia due to AD (i.e. Clinical Dementia Rating (CDR) score 1 for mild dementia or 0.5 for MCI)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up immediately post-treatment (an average of 3 months)
Awards & highlights

Study Summary

This trial will test a new exercise device to see if it helps people with mild cognitive impairment or mild Alzheimer's. The device tracks movement and records it on a computer.

Who is the study for?
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.Check my eligibility
What is being tested?
The 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.See study design
What are the potential side effects?
Since this trial involves an exercise program, potential side effects may include typical exercise-related issues such as muscle soreness or fatigue. The specifics will depend on individual health conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My condition is mild dementia or MCI due to Alzheimer's disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediately post-treatment (an average of 3 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately post-treatment (an average of 3 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in 30 second chair stand test
Change in Functional Reach Test
Change in Timed Up and Go test
Secondary outcome measures
Duration of exercise performed
Geriatric Depression Scale
Global Physical Activity Questionnaire
+2 more

Trial Design

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.

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Who is running the clinical trial?

Flint Rehabilitation Devices, LLCLead Sponsor
5 Previous Clinical Trials
156 Total Patients Enrolled
Rancho Research Institute, Inc.OTHER
7 Previous Clinical Trials
483 Total Patients Enrolled
Freddi Segal-Gidan, PA, PhDPrincipal InvestigatorRancho Research Institute, Inc.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any potential dangers associated with FitMi AD usage?

"FitMi AD received a score of 1, signifying that there is only minimal evidence backing its safety and efficacy due to it being an early-stage Phase I trial."

Answered by AI

What are the projected results from this medical investigation?

"This clinical trial seeks to measure the Change in Functional Reach Test over a baseline period and following 3 months of treatment. Secondary metrics include Geriatric Depression Scale (scores ranging from 0-4 for normal, 5-8 for mild depression, 9-11 for moderate depression, and 12-15 indicating severe depression), Global Physical Activity Questionnaire that reports physical activity habits, as well as Pittsburgh Sleep Quality Index with scores between 0 - 21 wherein lower numbers denote healthier sleep quality."

Answered by AI

Are there any remaining positions available to participate in this clinical trial?

"Per the information hosted at clinicaltrials.gov, this trial is not currently recruiting new patients; it was posted on September 1st and last updated on August 15th of 2022. Nevertheless, 1157 other studies are actively seeking participants now."

Answered by AI
~0 spots leftby Apr 2024