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Device
Delivery of iStride™ device gait treatment using telemedicine for Neurologic Gait Disorders
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
Study Summary
This trial will investigate whether the Moterum iStride Solution™ can improve gait in people with hemiparetic gait impairments when delivered via the Moterum Digital Platform.
Eligible Conditions
- Neurologic Gait Disorders
- Stroke
- Orthotics
- Gait Analysis
- 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.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Achievability of telemedicine delivery protocol
Feasibility of safely implementing the treatment protocol
Secondary outcome measures
Feasibility of screening criteria
Stakeholder Acceptability
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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Who is running the clinical trial?
Moterum Technologies, Inc.Lead Sponsor
2 Previous Clinical Trials
29 Total Patients Enrolled
Stephen T. Shultz, PT, DPT, OCSPrincipal InvestigatorWingate University
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