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FitMi Plus for Stroke

N/A
Waitlist Available
Led By David Reinkensmeyer, 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
Experienced 1 or more strokes >6 months prior to enrollment
Upper Extremity Fugl-Meyer Score >=15 and <=55 out of 66
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and one-month post-treatment, at seven weeks
Awards & highlights

Study Summary

This trial will compare the effectiveness of a new exercise device, FitMi Plus, to the FitMi Basic for people in the chronic stage after a stroke.

Eligible Conditions
  • Stroke

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and one-month post-treatment, at seven weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and one-month post-treatment, at seven weeks 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 Motor Activity Log
Secondary outcome measures
Change in Upper Extremity Fugl-Meyer

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: FitMi PlusExperimental Treatment1 Intervention
Participants will perform targeted movement exercises by interacting with the FitMi Plus Functional modules at least 50% of the time they spend exercising. Participants will be asked to exercise at least 3 hours per week for 3 consecutive weeks.
Group II: FitMi BasicActive Control1 Intervention
Participants will perform targeted movement exercises by interacting with the FitMi Basic pucks, as described and monitored on a computer. Participants will be asked to exercise at least 3 hours per week for 3 consecutive weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
FitMi Plus
2021
N/A
~50

Find a Location

Who is running the clinical trial?

Flint Rehabilitation Devices, LLCLead Sponsor
5 Previous Clinical Trials
136 Total Patients Enrolled
2 Trials studying Stroke
87 Patients Enrolled for Stroke
University of California, IrvineOTHER
536 Previous Clinical Trials
1,921,550 Total Patients Enrolled
19 Trials studying Stroke
1,797 Patients Enrolled for Stroke
Rancho Research Institute, Inc.OTHER
7 Previous Clinical Trials
463 Total Patients Enrolled
2 Trials studying Stroke
87 Patients Enrolled for Stroke

Frequently Asked Questions

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

Are individuals under the age of 20 able to partake in this medical experiment?

"This medical trial requires participants to be aged between 18 and 85, as stipulated by the inclusion parameters."

Answered by AI

How many subjects are engaged in this clinical investigation?

"Affirmative, clinicaltrials.gov confirms that this trial is still seeking enrolment into the study which was first published on July 1st 2021 and most recently updated on December 13th 2021. The medical research requires 50 patients to be recruited from two clinics."

Answered by AI

Is it feasible for me to join this clinical experiment?

"This clinical trial is recruiting 50 individuals between 18 and 85 years old who have suffered from a stroke. To qualify, applicants must demonstrate an understanding of how to use the FitMi products, possess an Upper Extremity Fugl-Meyer Score ranging from 15 to 55 out of 66, experienced one or more strokes at least 6 months prior to enrollment, and report no moderate to severe upper extremity pain (score less than 4 on the visual-analog pain scale)."

Answered by AI

Are there opportunities for individuals to participate in this trial at present?

"This clinical trial is actively recruiting participants, according to the information hosted on clinicaltrials.gov. The initial posting was made at the start of July 2021 and an update was uploaded in mid-December that same year."

Answered by AI
~15 spots leftby Mar 2025