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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
Must not have
Aphasic patients unable to communicate
Patients unable to stand alone
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (day 1) and at 4-weeks to measure change

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.
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.
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.
Select...
My heart and lungs are stable enough for daily treatments.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I cannot speak or understand speech due to a brain condition.
Select...
I cannot stand by myself.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The Functional Independence Measure (FIM™)
The two minute walk test (2-MWT)
Secondary study objectives
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

Find a Location

Who is running the clinical trial?

University of OklahomaLead Sponsor
473 Previous Clinical Trials
93,631 Total Patients Enrolled
4 Trials studying Stroke
128 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
~17 spots leftby Sep 2026
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