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Exoskeleton

Exoskeleton-Assisted Walking for Stroke Rehabilitation

N/A

Recruiting

Led By Meheroz H Rabadi, MD, MRCPI

Research Sponsored by University of Oklahoma

Eligibility Criteria Checklist

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

Must have

All patients with acute hemorrhagic or ischemic stroke documented clinically and by neuroimaging

Medically stable from a cardio-respiratory stand point so that they can participate in daily therapies

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (day 1) and at 4-weeks to measure change

Awards & highlights

Study Summary

This trial will test if a machine that helps people walk can improve rehab outcomes for stroke patients.

Who is the study for?

This trial is for patients who have had a stroke and are stable enough to do daily therapies. They must be able to understand the study (with an MMSE score of at least 21), give written consent, and stand on their own. People with severe communication issues or confusion, those who can't stand alone, or refuse to consent cannot join.Check my eligibility

What is being tested?

The study tests if using an electromechanical exoskeleton (Indego Exoskeleton) during gait training helps improve walking and movement better than standard rehabilitation alone in stroke patients at an in-patient facility.See study design

What are the potential side effects?

Potential side effects may include discomfort while using the exoskeleton, skin irritation from device contact points, muscle soreness due to new movements, and fatigue from increased physical activity.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have had a stroke confirmed by a doctor and scans.

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My heart and lungs are stable enough for daily treatments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (day 1) and at 4-weeks to measure change

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (day 1) and at 4-weeks to measure change

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (day 1) and at 4-weeks to measure change for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

The Functional Independence Measure (FIM™)

The two minute walk test (2-MWT)

Secondary outcome measures

Discharge disposition

Modified Ashworth Scale (MAS)

The Beck Depression Inventory (BDI)

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Exo-groupExperimental Treatment2 Interventions

Standard rehabilitation plus use of Exoskeleton

Group II: Control-GroupPlacebo Group1 Intervention

Standard rehabilitation

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Indego Exoskeleton

2017

N/A

~90

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of OklahomaLead Sponsor

455 Previous Clinical Trials

95,873 Total Patients Enrolled

3 Trials studying Stroke

46 Patients Enrolled for Stroke

Meheroz H Rabadi, MD, MRCPIPrincipal InvestigatorAffiliate; Oklahoma VA Health Care System

3 Previous Clinical Trials

146 Total Patients Enrolled

2 Trials studying Stroke

130 Patients Enrolled for Stroke

Media Library

Indego Exoskeleton (Exoskeleton) Clinical Trial Eligibility Overview. Trial Name: NCT03980457 — N/A

Stroke Research Study Groups: Control-Group, Exo-group

Stroke Clinical Trial 2023: Indego Exoskeleton Highlights & Side Effects. Trial Name: NCT03980457 — N/A

Indego Exoskeleton (Exoskeleton) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03980457 — N/A

Frequently Asked Questions

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

What is the participant size for this experiment?

"Affirmative. According to information published on clinicaltrials.gov, this medical experiment is still looking for participants and was initially uploaded on September 1st 2021. In total, 50 patients must be recruited from one site before the trial can start properly."

Answered by AI

Are there any slots remaining for participants in this research endeavor?

"Affirmative. According to clinicaltrials.gov, this experiment is actively seeking participants and was first published on the 1st of September 2021 with a most recent update dated 17th May 2022. The study requires 50 individuals from a single location."

Answered by AI