search
Back to results

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

Primary Purpose

Cognitive Dysfunction, Dementia, Mild

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FitMi AD
Conventional exercise program
Sponsored by
Flint Rehabilitation Devices, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cognitive Dysfunction

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rancho Research Institute, IncRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental: FitMi AD Exercise Program

Active Comparator: Conventional booklet of exercise program

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in Functional Reach Test
How far can someone reach while standing in a fixed position
Change in Timed Up and Go test
Time it takes to stand up from a chair and walk a short distance
Change in 30 second chair stand test
How many times someone stand up from a chair in 30 seconds

Secondary Outcome Measures

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.
Global Physical Activity Questionnaire
Assesses physical activity habits
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.
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.
Duration of exercise performed
Duration of exercise performed over intervention period.

Full Information

First Posted
August 12, 2022
Last Updated
September 12, 2023
Sponsor
Flint Rehabilitation Devices, LLC
Collaborators
Rancho Research Institute, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT05504811
Brief Title
FitMi AD Home Therapy for Individuals With MCI or Mild Dementia Due to Alzheimer's Disease
Official Title
FitMi AD: a Safe and Motivating Computer-guided Exercise System for Individuals With MCI or Mild Dementia Due to Alzheimer's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
April 10, 2024 (Anticipated)
Study Completion Date
April 10, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Flint Rehabilitation Devices, LLC
Collaborators
Rancho Research Institute, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Dysfunction, Dementia, Mild

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Single (Outcomes Assessor)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental: FitMi AD Exercise Program
Arm Type
Experimental
Arm Description
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.
Arm Title
Active Comparator: Conventional booklet of exercise program
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
FitMi AD
Intervention Description
Exercise using the motion sensing devices and a tablet computer
Intervention Type
Other
Intervention Name(s)
Conventional exercise program
Intervention Description
Exercise following printed sheets or booklet
Primary Outcome Measure Information:
Title
Change in Functional Reach Test
Description
How far can someone reach while standing in a fixed position
Time Frame
Baseline, Immediately Post-Treatment (an average of 3 months)
Title
Change in Timed Up and Go test
Description
Time it takes to stand up from a chair and walk a short distance
Time Frame
Baseline, Immediately Post-Treatment (an average of 3 months)
Title
Change in 30 second chair stand test
Description
How many times someone stand up from a chair in 30 seconds
Time Frame
Baseline, Immediately Post-Treatment (an average of 3 months)
Secondary Outcome Measure Information:
Title
Visual Analog Pain Scale
Description
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.
Time Frame
Baseline, Immediately Post-Treatment (an average of 3 months)
Title
Global Physical Activity Questionnaire
Description
Assesses physical activity habits
Time Frame
Baseline, Immediately Post-Treatment (an average of 3 months)
Title
Geriatric Depression Scale
Description
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.
Time Frame
Baseline, Immediately Post-Treatment (an average of 3 months)
Title
Pittsburgh Sleep Quality Index
Description
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.
Time Frame
Baseline, Immediately Post-Treatment (an average of 3 months)
Title
Duration of exercise performed
Description
Duration of exercise performed over intervention period.
Time Frame
Immediately Post-Treatment (an average of 3 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel Zondervan, PhD
Phone
949-313-7322
Email
dzondervan@flintrehab.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ian Russell, PhD
Phone
339-223-2676
Email
irussell@flintrehab.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Freddi Segal-Gidan, PA, PhD
Organizational Affiliation
Rancho Research Institute, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rancho Research Institute, Inc
City
Downey
State/Province
California
ZIP/Postal Code
90242
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marielena Meza
Phone
562-385-7463
Email
marielenam@ranchoresearch.org

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs