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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up daily and change in baseline to weeks 6 and 12
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am currently not suffering from any serious illnesses or infections.
Select...
I can walk 10 feet by myself or with help or devices.
Select...
I am between 18 and 80 years old.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
10-Meter Walk Test (10MWT)
6-Minute Walk Test (6MWT)
Secondary outcome measures
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
Find a Location
Who is running the clinical trial?
Brooks RehabilitationLead Sponsor
13 Previous Clinical Trials
1,732 Total Patients Enrolled
University of FloridaOTHER
1,340 Previous Clinical Trials
715,684 Total Patients Enrolled
Emily J Fox, DPT, PhDPrincipal InvestigatorBrooks Rehabilitation
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently not suffering from any serious illnesses or infections.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.I cannot stand or walk properly due to joint stiffness in my legs.I don't have skin issues that would stop me from walking rehab.I do not have any uncontrolled health issues like heart disease or infections.I don't have recent fractures or bone conditions that would make walking unsafe.I have muscle stiffness or uncontrolled movements that make it hard for me to walk.My body size may not be safe for certain medical equipment use.I have not had Botox injections in my leg muscles within the last 4 months.I can walk 10 feet by myself or with help or devices.I have a spinal cord injury that still allows for some feeling or movement, and it happened over a year ago.My pain stops me from walking or joining in walking rehab.I am between 18 and 80 years old.I am currently in a program to improve my walking.I am legally blind or have severe vision problems.
Research Study Groups:
This trial has the following groups:- Group 1: Locomotor training using adaptive robot
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.
Are the elderly able to participate in this medical research endeavor?
"The eligibility criteria for this medical study specifies a minimum age of 18 and maximum age of 80."
Answered by AI
How many participants are partaking in this research endeavor?
"Correct, clinicaltrials.gov's records show that this trial is actively enrolling patients. The research was initially published on November 29th 2018 and was recently amended on December 3rd 2021. This study requires 24 participants from one medical site to take part."
Answered by AI
Who is eligible to become involved with this research project?
"This clinical trial is recruiting 24 people with spinal cord injuries aged between 18 and 80. To qualify, applicants must possess the following characteristics: Adults in age from 18 - 80 years old; diagnosed with a chronic sensory or motor incomplete spinal cord injury (ASIA Impairment Scale (AIS) B, C, D); post-injury for over one year; medically stable without acute illness/infections; obtained physician approval to join study procedures; able to walk 10 feet independently or aided by gait assistive devices and orthotics; willing to provide informed consent."
Answered by AI
Is there still room to enroll participants in this research endeavor?
"The clinical trial is currently enrolling patients, as evidenced on clinicaltrials.gov; the initial posting was November 29th 2018 and it has been updated most recently on December 3rd 2021."
Answered by AI
Who else is applying?
What site did they apply to?
Brooks Rehabilitation
What portion of applicants met pre-screening criteria?
Met criteria
Why did patients apply to this trial?
I get around with a cane and Walker.
PatientReceived 1 prior treatment
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