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FitMi Plus Home Therapy for Stroke Patients

NCT03935425 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-03-12

Study results available
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Summary

The investigators will investigate the efficacy of a newly developed functional exercise device (FitMi Plus) for people in the chronic stage after a stroke compared to the FitMi Basic (i.e. without functional exercises). FitMi Plus combines objects commonly used during activities of daily living with sensors that can track and record the patient's direction and degree of movement as they perform specific functional tasks described on a computer.

Conditions

  • Cerebral Stroke

Interventions

DEVICE

FitMi Plus

A set of common objects that couple with a wireless sensor platform to allow the performance of functional exercises to be measured by a motivating software platform.

DEVICE

FitMi Basic

A wireless sensor platform that allows movement subcomponents and point-to-point exercises to be measured by a motivating software platform.

Sponsors & Collaborators

  • University of California, Irvine

    collaborator OTHER

  • Rancho Research Institute, Inc.

    collaborator OTHER

  • Flint Rehabilitation Devices, LLC

    lead INDUSTRY

Principal Investigators

  • David Reinkensmeyer, PhD · University of California, Irvine

  • Susan Shaw, MD · Rancho Research Institute, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-29
Primary Completion
2022-10-31
Completion
2022-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03935425 on ClinicalTrials.gov