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Robotic Controllers for Motor Learning After Neurological Injuries (HRCEML Trial)

N/A

Recruiting

Led By Jose Pons, Ph.D

Research Sponsored by Shirley Ryan AbilityLab

Eligibility Criteria Checklist

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

Must have

No history of a brain and/or skull lesion

Normal hearing and vision, can be corrected

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change in score at baseline, midpoint of intervention after 10 training sessions with assistive robot, and endpoint after 10 additional training sessions with the other assistive robot through participant completion, an average of 5 months.

Awards & highlights

HRCEML Trial Summary

This trial is looking at how humans physically interact with each other and how that might help develop robot controllers that can exhibit human-like behavior.

Who is the study for?

This trial is for individuals aged 18-80 with normal hearing and vision, who can understand English and give informed consent. It's suitable for healthy participants as well as those post-stroke or with spinal cord injury (SCI), provided they can walk over 10m independently. People with brain lesions, neurological disorders, abnormal limb movements, or outside the height range of 3'6" to 6'2" cannot join.Check my eligibility

What is being tested?

The study aims to develop robot controllers that mimic human behavior in physical interactions. These will be tested on single joint (ankle) and multi-joint (ankle, knee, hip) robots using variable haptic behaviors like collaboration and competition to enhance motor learning in humans.See study design

What are the potential side effects?

Since this trial involves behavioral interaction conditions rather than medical interventions or drugs, traditional side effects are not applicable. However, there may be fatigue or discomfort from interacting with the robotic devices.

HRCEML Trial Eligibility Criteria

Inclusion Criteria

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

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I have never had a brain or skull lesion.

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My hearing and vision are normal or corrected to normal.

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I am between 18 and 80 years old.

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I don't have conditions that cause abnormal limb movements.

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I do not have any neurological disorders.

HRCEML Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change in score at baseline, midpoint of intervention after 10 training sessions with assistive robot, and endpoint after 10 additional training sessions with the other assistive robot through participant completion, an average of 5 months.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change in score at baseline, midpoint of intervention after 10 training sessions with assistive robot, and endpoint after 10 additional training sessions with the other assistive robot through participant completion, an average of 5 months.

This trial's timeline: 3 weeks for screening, Varies for treatment, and change in score at baseline, midpoint of intervention after 10 training sessions with assistive robot, and endpoint after 10 additional training sessions with the other assistive robot through participant completion, an average of 5 months. for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Change in lower limb motor control.

Change in motor output from surface EMG of lower limb muscles

Secondary outcome measures

Change in 10 meter walking test.

Change in 6 minute walking test.

Change in BERG balance scale (BBS)

+8 more

HRCEML Trial Design

4Treatment groups

Experimental Treatment

Group I: Healthy Participants Bilateral Lower Limb Exoskeleton (H3/X2)Experimental Treatment3 Interventions

The investigators will look at how the task performance and motor performance of individuals in dyadic physical interactions are affected.

Group II: Healthy Participants Ankle Robot (M1)Experimental Treatment3 Interventions

The investigators will look at how the task performance and motor performance of individuals in dyadic physical interactions are affected.

Group III: Clinical Populations Bilateral Lower Limb Exoskeleton (H3/X2)Experimental Treatment4 Interventions

The investigators will look at how the task performance and motor performance of individuals in dyadic physical interactions are affected.

Group IV: Clinical Populations Ankle Robot (M1)Experimental Treatment4 Interventions

The investigators will look at how the task performance and motor performance of individuals in dyadic physical interactions are affected.

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

U.S. National Science FoundationFED

34 Previous Clinical Trials

8,330 Total Patients Enrolled

2 Trials studying Stroke

12 Patients Enrolled for Stroke

Shirley Ryan AbilityLabLead Sponsor

194 Previous Clinical Trials

16,368 Total Patients Enrolled

70 Trials studying Stroke

7,801 Patients Enrolled for Stroke

Jose Pons, Ph.DPrincipal Investigator - Shirley Ryan AbilityLab

Shirley Ryan AbilityLab

1 Previous Clinical Trials

100 Total Patients Enrolled

Media Library

Behavioral Interaction Conditions Clinical Trial Eligibility Overview. Trial Name: NCT04578665 — N/A

Behavioral Interaction Conditions 2023 Treatment Timeline for Medical Study. Trial Name: NCT04578665 — N/A

Stroke Research Study Groups: Healthy Participants Ankle Robot (M1), Clinical Populations Ankle Robot (M1), Clinical Populations Bilateral Lower Limb Exoskeleton (H3/X2), Healthy Participants Bilateral Lower Limb Exoskeleton (H3/X2)

Stroke Clinical Trial 2023: Behavioral Interaction Conditions Highlights & Side Effects. Trial Name: NCT04578665 — N/A

Frequently Asked Questions

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

May I be admitted into this clinical trial?

"To be eligible to participate in this trial, individuals must have sustained a spinal cord injury and fit into the age range between 18 and 80. At present, there is an effort underway to recruit 544 participants."

Answered by AI

What is the current recruitment rate for this medical experiment?

"Correct, the clinical trial database has information indicating that this medical study is seeking participants. It was first announced on July 13th 2021 and last updated a year later; it requires up to 544 individuals from one site for completion."

Answered by AI

Are there any current opportunities to enroll in this experiment?

"Affirmative, the clinicaltrials.gov website states that this trial is currently recruiting participants. It was first published on July 13th 2021 and recently updated for a one-year period ending July 13th 2022. This research requires 544 individuals to be enlisted from 1 site."

Answered by AI

What are the main goals of this research endeavor?

"This trial will evaluate participants' motor output, balance while walking (FGA scale 0-30), static and dynamic sitting/standing balance (BBS range of 0-56) via BERG Balance Scale, and strength with a dynamometer over an average 5 month period. Secondary outcomes include changes in Functional Gait Assessment score, BERG Balance Scale results, and dynamometer testing for muscular force production."

Answered by AI