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Robotic Device

Robotic-Assisted Walking Rehabilitation for Spinal Cord Injury

N/A

Waitlist Available

Led By Emily J Fox, DPT, PhD

Research Sponsored by Brooks Rehabilitation

Eligibility Criteria Checklist

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

Must have

Medically stable with no acute illness, infections

Able to walk 10 feet with or without assistance, gait assistive devices and/or orthotics

Must not have

Additional neurologic conditions such multiple sclerosis, Parkinson's disease, stroke, brain injury

Cognitive or communication impairments limiting communication with study staff or ability to provide informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up daily and change in baseline to weeks 6 and 12

Awards & highlights

Summary

This trial will test the safety and efficacy of using a robotic device to help with locomotor training for people with spinal cord injuries, to improve walking function.

Who is the study for?

This trial is for adults aged 18-80 with chronic, incomplete spinal cord injury who can walk at least 10 feet with or without help. They must be over a year post-injury, able to consent, medically stable, and have physician approval. Excluded are those with cognitive impairments, severe joint contractures, current rehab participation, recent Botox in leg muscles affecting walking function within the last four months.

What is being tested?

The study tests the Hybrid Assistive Limb (HAL), an adaptive robotic device designed to improve walking rehabilitation after spinal cord injury by matching natural human stepping patterns during locomotor training. It's being evaluated for safety and effectiveness in U.S. patients.

What are the potential side effects?

While not explicitly listed in the provided information, potential side effects may include discomfort from wearing HAL equipment or fatigue due to physical exertion during rehabilitation sessions.

Eligibility Criteria

Inclusion Criteria

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

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I am currently not suffering from any serious illnesses or infections.

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I can walk 10 feet by myself or with help or devices.

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I am between 18 and 80 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a neurological condition like MS, Parkinson's, had a stroke, or brain injury.

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I can communicate clearly and understand the details of the study.

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I cannot stand or walk properly due to joint stiffness in my legs.

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I don't have skin issues that would stop me from walking rehab.

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I do not have any uncontrolled health issues like heart disease or infections.

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I don't have recent fractures or bone conditions that would make walking unsafe.

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I have muscle stiffness or uncontrolled movements that make it hard for me to walk.

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My pain stops me from walking or joining in walking rehab.

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I am legally blind or have severe vision problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ daily and change in baseline to weeks 6 and 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~daily and change in baseline to weeks 6 and 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and daily and change in baseline to weeks 6 and 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

10-Meter Walk Test (10MWT)

6-Minute Walk Test (6MWT)

Secondary study objectives

Electromyogram (EMG) will be used to assess the neuromuscular activation of the lower extremities

Trial Design

1Treatment groups

Experimental Treatment

Group I: Locomotor training using adaptive robotExperimental Treatment1 Intervention

The intervention will consist of 60 sessions of locomotor training using the HAL adaptive robot. The training sessions will be scheduled 5 days per week for 12 weeks. A physical therapist with expertise in SCI walking rehabilitation and use of the HAL will oversee all intervention sessions. The intervention sessions will include up to a total of 40 minutes of stepping time, which may take up to 2 hours to complete due to set up time and rest breaks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Hybrid Assistive Limb (HAL)

2015

N/A

~50

0 / 12Eligibility criteria met

Find a Location

Who is running the clinical trial?

Brooks RehabilitationLead Sponsor

14 Previous Clinical Trials

1,782 Total Patients Enrolled

University of FloridaOTHER

1,380 Previous Clinical Trials

762,374 Total Patients Enrolled

Emily J Fox, DPT, PhDPrincipal InvestigatorBrooks Rehabilitation

Media Library

Hybrid Assistive Limb (HAL) (Robotic Device) Clinical Trial Eligibility Overview. Trial Name: NCT03504826 — N/A

Spinal Cord Injury Research Study Groups: Locomotor training using adaptive robot

Spinal Cord Injury Clinical Trial 2023: Hybrid Assistive Limb (HAL) Highlights & Side Effects. Trial Name: NCT03504826 — N/A

Hybrid Assistive Limb (HAL) (Robotic Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03504826 — N/A

~3 spots leftby Sep 2025

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