Robotic-Assisted Walking Rehabilitation for Spinal Cord Injury

LD
Emily Fox profile photo
Overseen ByEmily Fox
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve walking function for people with spinal cord injuries using a new robotic device called the Hybrid Assistive Limb (HAL). The device aids walking by adapting to a person's muscle movements, creating a more natural experience. The goal is to determine if this robotic-assisted method is safe and beneficial compared to traditional physical therapy. This trial may suit individuals who have had a spinal cord injury for over a year, can walk at least 10 feet with some assistance, and are medically stable. As an unphased trial, it offers a unique opportunity to explore innovative technology that could enhance mobility and quality of life.

What prior data suggests that this robotic device is safe for walking rehabilitation in SCI patients?

Research has shown that the Hybrid Assistive Limb (HAL) robot is safe for helping people walk again. Recent studies in Europe have used the HAL device to assist patients with spinal cord injuries (SCIs) in learning to walk. These studies found that patients managed the device well during training, with no serious side effects. The HAL robot adjusts to the user's movements, making the training feel more natural. This personalized support may also reduce the risk of injury during sessions. While more research is needed, current evidence suggests that using the HAL for walking rehabilitation is generally safe for people with SCIs.12345

Why are researchers excited about this trial?

Researchers are excited about the Hybrid Assistive Limb (HAL) for spinal cord injury rehabilitation because it combines robotics with traditional therapy to enhance recovery. Unlike standard treatments like physical therapy alone, HAL uses a robotic exoskeleton that adapts to the user's movements, providing real-time assistance and feedback to improve walking ability. This innovative approach could lead to more significant improvements in mobility and independence for patients compared to conventional methods.

What evidence suggests that this adaptive robotic device is effective for spinal cord injury rehabilitation?

Research has shown that the Hybrid Assistive Limb (HAL), used by participants in this trial, can significantly aid individuals with spinal cord injuries (SCIs) in improving mobility. One study found that after 90 days of using HAL, patients showed improvement in walking and overall movement. Other studies have also demonstrated that patients walked faster, farther, and for longer durations. The HAL senses muscle signals, assisting patients in walking by mimicking natural movements. This robotic suit is considered a promising tool for enhancing recovery in SCI patients.678910

Who Is on the Research Team?

EJ

Emily J Fox, DPT, PhD

Principal Investigator

Brooks Rehabilitation

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am currently not suffering from any serious illnesses or infections.
Obtained physician approval to participate in study procedures
I can walk 10 feet by myself or with help or devices.
See 2 more

Exclusion Criteria

I don't have skin issues that would stop me from walking rehab.
I have a neurological condition like MS, Parkinson's, had a stroke, or brain injury.
I can communicate clearly and understand the details of the study.
See 11 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
Phone and in-person screenings

Treatment

Participants undergo locomotor training using the HAL adaptive robot, 5 days per week for 12 weeks

12 weeks
60 sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of walking speed and endurance

4 weeks
2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Hybrid Assistive Limb (HAL)

Trial Overview

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.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Locomotor training using adaptive robotExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Brooks Rehabilitation

Lead Sponsor

Trials
16
Recruited
1,900+

University of Florida

Collaborator

Trials
1,428
Recruited
987,000+

Citations

"Hybrid Assistive Limb Exoskeleton HAL in the ...

RESULTS: After a training period of 90 days, all 21 patients significantly improved their functional and ambulatory mobility without the ...

Hybrid Assistive Limb (HAL) Treatment for Spinal Cord ...

“We've already seen the results of improved mobility and ability to walk in patients with spinal cord injury (SCI) at several international ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/34776919/

Rehabilitation of Acute Vs. Chronic Patients With Spinal ...

This study aimed to assess the outcome of acute and chronic participants with spinal cord injury (SCI) after 12 weeks of bodyweight supported ...

Hybrid Assisted Limb Therapy (HAL) | Technology

Hybrid assisted limb (HAL) is a robotic exoskeleton that detects muscle signals to help people with neurological conditions walk. See how Brooks uses it.

Robotic exoskeleton HAL improves spinal cord injury rehab

Researchers in Germany have found that an intense rehabilitation program using HAL improves walking speed, walking distance, walking time, and ...

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