Delivery of iStride™ device gait treatment using telemedicine for Stroke

N/A

Waitlist Available

Led By Stephen T. Shultz, PT, DPT, OCS

Research Sponsored by Moterum Technologies, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up determined within one week after the final follow-up assessment (12-month follow-up) is completed. the 12-month follow-up assessment will occur 12-months after completion of the 4-week treatment period.

Awards & highlights

No Placebo-Only Group

Summary

This trial tests the Moterum iStride Solution™, a device that helps stroke survivors improve their walking by making it more even and safe. It is designed for people who have trouble walking due to a stroke. The device mimics a special treadmill and uses sensors to track progress, with therapists providing remote support through video calls.

Eligible Conditions

Stroke
Neurologic Locomotion Disorder
Neurologic Gait Disorders
Gait Analysis
Orthotics
Telemedicine
Hemiplegic Gait

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ determined within one week after the final follow-up assessment (12-month follow-up) is completed. the 12-month follow-up assessment will occur 12-months after completion of the 4-week treatment period.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~determined within one week after the final follow-up assessment (12-month follow-up) is completed. the 12-month follow-up assessment will occur 12-months after completion of the 4-week treatment period.

This trial's timeline: 3 weeks for screening, Varies for treatment, and determined within one week after the final follow-up assessment (12-month follow-up) is completed. the 12-month follow-up assessment will occur 12-months after completion of the 4-week treatment period. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Achievability of telemedicine delivery protocol

Feasibility of safely implementing the treatment protocol

Secondary study objectives

Feasibility of screening criteria

Stakeholder Acceptability

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Delivery of iStride™ device gait treatment using telemedicineExperimental Treatment1 Intervention

Treatment with the gait device will be adapted to remote delivery using the telemedicine platform. Participants and caregivers will be guided through an adapted treatment protocol remotely by physical therapists. Training will include platform navigation, device instruction, treatment guidelines, safety precautions, and assessment performance. Understanding will be verified through a caregiver quiz. Gait patterns will be monitored before, during, and after treatment using gait sensors and outcome measures. Assessments include the 10-Meter Walk Test, Six Minute Walk Test, Timed Up and Go Test, Geriatric Depression Scale, Activities-Specific Balance Confidence Scale, and Stroke Impact Scale-16. Treatment will consist of 12 sessions of walking on the device for a goal of 30 minutes per session. Assessments will be repeated one-week, one-month, three-months, six-months, and 12-months after treatment. Feasibility and safety of the delivery method will be measured throughout the trial.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Delivery of iStride™ device gait treatment using telemedicine

2020

N/A

~10

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