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High-intensity Gait Training for Stroke Recovery
N/A
Waitlist Available
Led By Arun Jayaraman, PhD
Research Sponsored by Shirley Ryan AbilityLab
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 week 1, week 2, week 3
Awards & highlights
Study Summary
This trial will study the effects of two different types of intense gait training on people who have had a stroke, focusing on mobility, strength, balance, and endurance.
Who is the study for?
This trial is for individuals aged 18-80 who've had a stroke in the last six months and show contraversive pushing behaviors. They must be medically cleared, have certain cognitive function levels, speak English, and consent to participate. Excluded are those with severe communication issues or neglect, prior strokes, other neurological conditions, severe osteoporosis, open wounds where equipment touches skin, unstable spines or fractures, DVTs not resolved yet.Check my eligibility
What is being tested?
The study compares two high-intensity walking training methods: one using a body-weight-supported treadmill and another using an EksoNR exoskeleton by Ekso Bionics. It aims to see how these affect post-stroke patients' pushing behaviors and overall mobility including strength balance and endurance while also assessing the strain on therapists.See study design
What are the potential side effects?
While specific side effects aren't listed for this type of physical therapy intervention trial participants may experience general discomfort fatigue muscle soreness or skin irritation from contact with the devices.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 1, week 2, week 3
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 1, week 2, week 3
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Burke Lateropulsion Scale
Change in Scale for Contraversive Pushing
Secondary outcome measures
Change in 10 Meter Walk Test
Change in 6 Minute Walk Test
Change in Berg Balance Scale
+10 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: EksoNR exoskeletonExperimental Treatment1 Intervention
Participants complete prescribed gait training program for at least three weeks or until they discharge.
Group II: Body-weight-supported treadmill trainingExperimental Treatment1 Intervention
Participants complete prescribed gait training program for at least three weeks or until they discharge.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ekso Bionics EksoNR exoskeleton
2021
N/A
~20
Body-weight-supported treadmill
2021
N/A
~20
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Who is running the clinical trial?
Shirley Ryan AbilityLabLead Sponsor
192 Previous Clinical Trials
14,871 Total Patients Enrolled
69 Trials studying Stroke
6,331 Patients Enrolled for Stroke
Arun Jayaraman, PhDPrincipal Investigator - Shirley Ryan AbilityLab
Shirley Ryan AbilityLab
5 Previous Clinical Trials
241 Total Patients Enrolled
2 Trials studying Stroke
81 Patients Enrolled for Stroke
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have severe difficulty talking or expressing yourself.You have severe neglect behavior, as shown by a high score on the Catherine Bergego Scale.You have had a stroke in the past.You have another ongoing neurological condition, like Parkinson's disease, traumatic brain injury, or multiple sclerosis.You have had a past injury to the nerves in your arms or legs.You have severe stiffness or tightness in your lower limbs.You have very serious osteoporosis, as confirmed by a doctor.You have a blood clot in a deep vein that has not been treated yet.You are between 18 and 80 years old.You had a stroke on one side of your brain within the last six months.You exhibit contraversive pushing behaviors as indicated by a score higher than 0 on the Scale for Contraversive Pushing.You have severe osteoarthritis in your knee, hip, or ankle.You have any open wounds where the exoskeleton or harness touches your body.You have a spine that is not strong or fractures that have not healed.You need to avoid putting weight on a certain part of your body.
Research Study Groups:
This trial has the following groups:- Group 1: Body-weight-supported treadmill training
- Group 2: EksoNR exoskeleton
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the purpose of this experiment?
"The aim of this 8-week clinical trial is to assess the Burke Lateropulsion Scale. Additionally, the study will look at how effective the medication is by measuring changes in patients' 6 Minute Walk Test score, their Modified Ashworth Scale score, and Manual Muscle Test results."
Answered by AI
Does this study have an age limit, and if so, what is it?
"Based on the age limit set by the trial's eligibility criteria, any person over 18 and under 80 years old can participate."
Answered by AI
For which kind of patients is this research opportunity open?
"Eligibility requirements for this study include being between 18-80 years old and having suffered a stroke. The trial is currently recruiting approximately 10 individuals."
Answered by AI
Are new participants being enrolled in this clinical trial at this time?
"The latest information on clinicaltrials.gov suggests that this particular trial is actively recruiting patients. The listing for the trial was first posted on January 1st, 2021 and updated most recently on May 3rd, 2022."
Answered by AI
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