All > Hemiplegia

Implantation, controller development, and evaluation for Hemiplegic Gait

Louis Stokes Cleveland Veterans Affairs Medical Center, Cleveland, OH
Hemiplegic Gait+2 More ConditionsIST 12 & IST 16 - Device
Eligibility
21 - 75
All Sexes

Study Summary

This trial will evaluate if a stimulator implant can help stroke survivors walk better. It includes two phases of testing and implantation.

Eligible Conditions
  • Hemiplegic Gait
  • Hemiplegia
  • Stroke

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
N/A

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Study Objectives

1 Primary · 1 Secondary · Reporting Duration: baseline, ~18 weeks post implant, ~44-week post implant

Week 44
Difference in Gait speed
Week 18
Difference in Usability Rating Scale (URS)

Trial Safety

Phase-Based Safety

1 of 3

Similar Trials

1
Sensory Augmentation
1
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1
Peripheral nerve stimulation

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

1 Treatment Group

Implantation, controller development, and evaluation
1 of 1

Experimental Treatment

6 Total Participants · 1 Treatment Group

Primary Treatment: Implantation, controller development, and evaluation · No Placebo Group · N/A

Implantation, controller development, and evaluationExperimental Group · 2 Interventions: IST 12 & IST 16, IRS-8 · Intervention Types: Device, Device
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
IRS-8
1996
N/A
~20

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, ~18 weeks post implant, ~44-week post implant

Who is running the clinical trial?

Cleveland State UniversityOTHER
12 Previous Clinical Trials
2,063 Total Patients Enrolled
MetroHealth Medical CenterLead Sponsor
110 Previous Clinical Trials
21,288 Total Patients Enrolled
1 Trials studying Hemiplegic Gait
60 Patients Enrolled for Hemiplegic Gait
Case Western Reserve UniversityOTHER
282 Previous Clinical Trials
199,403 Total Patients Enrolled
Louis Stokes VA Medical CenterFED
19 Previous Clinical Trials
3,403 Total Patients Enrolled
Nathan Makowski, PhDPrincipal InvestigatorThe MetroHealth System

Eligibility Criteria

Age 21 - 75 · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You had a stroke at least 6 months ago.
You have muscles in your legs and trunk that can move and respond to signals from the nervous system.
You have difficulty moving your hip, knee, or ankle while walking or standing.
You have enough help and a stable living situation.
References

Frequently Asked Questions

Which demographics can sign up to take part in this investigation?

"To become a participant in this clinical trial, individuals must be between 21 and 75 years of age with a stroke diagnosis. There are 6 openings available." - Anonymous Online Contributor

Unverified Answer

Does this research program still have availability for participants?

"According to the latest information on clinicaltrials.gov, this medical experiment is still in search of participants. It was initially posted on November 30th 2022 and its most recent update happened on February 13th 2023." - Anonymous Online Contributor

Unverified Answer

Does the research team include elderly participants aged 80 and over?

"To qualify for this trial, the individual must be between 21 and 75 years of age. Patients that are younger than 18 can opt to join one of 43 other studies available while those over 65 may choose from 1043 different clinical trials." - Anonymous Online Contributor

Unverified Answer

How many participants have been invited to take part in this project?

"Indeed, the data posted on clinicaltrials.gov verifies that this medical trial is currently recruiting participants. This project was initially launched on November 30th 2022 and recently updated on February 13th 2023. At present, 6 individuals are needed between two distinct locations." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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