Walking Rehabilitation After Spinal Cord Injury: Locomotor Training Using Adaptive Robotics
Key facts
- Who runs it
- Brooks Rehabilitation
- Where
- Jacksonville, United StatesSee the site
- Trial code
- Status
- Active, not recruiting
- People taking part
- 21 people enrolled
- Started
- 29 Nov 2018
- Expected to end
- 31 Dec 2026
- Type of study
- Interventional
- Treatments tested
- Hybrid Assistive Limb (HAL)
- Record updated
- 19 October 2026
Who can take part
- Age
- 18 years to 80 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 20 criteriaShow less
Who can take part
- Adults 18 - 80 years old
- Diagnosed with chronic, sensory or motor incomplete spinal cord injury (ASIA Impairment Scale (AIS) B, C, D), >1 year post injury
- Medically stable with no acute illness, infections
- Obtained physician approval to participate in study procedures
- Able to walk 10 feet with or without assistance, gait assistive devices and/or orthotics
- Able to provide informed consent
Who cannot take part
- Pacemaker or medical device implants which may interfere with the use of the HAL
- Additional neurologic conditions such multiple sclerosis, Parkinson's disease, stroke, brain injury
- Presence of unstable or uncontrolled medical conditions such as cardiovascular disease, myocardial infarction (<1 year), pulmonary infection or illness, renal disease, autonomic dysreflexia, infections, pain, heterotopic ossification
- Legal blindness or severe visual impairment
- Cognitive or communication impairments limiting communication with study staff or ability to provide informed consent
- Lower extremity joint contractures limiting the ability to stand upright and practice walking
- Skin lesions or wounds affecting participation in walking rehabilitation
- Acute or unstable fracture, diagnosis of osteoarthritis or bone impairments affecting safe participation in walking rehabilitation
- Spasticity or uncontrolled movements limiting participation in walking rehabilitation
- Body weight or height that is incompatible with safe use of the HAL and/or use of a support harness and body weight support system
- Pain that limits walking or participation in walking rehabilitation
- Current participation in rehabilitation to address walking function
- Botox injections in lower extremity muscles affecting walking function within 4 months of study enrollment
- Known pregnancy
Where in United States
- Brooks RehabilitationJacksonville, United States
About the trial
What the trial wants to find out
Locomotor training is an established rehabilitation approach that is beneficial for improving walking function in individuals with spinal cord injuries (SCIs). This approach focuses on repetitive practice and appropriate stepping movements to activate spinal neural networks and promote rhythmic motor output associated with walking. Assistance with stepping movements is often provided by physical therapists and trainers, but this can be costly and difficult to deliver in the cost-constrained U.S. healthcare market. Robotic devices have been used as an alternate method to deliver locomotor training, but current robotic approaches often lack the natural movement variations that characterize normal human stepping. Furthermore, studies to compare locomotor training approaches have not shown any specific benefits of using robotic devices. A new type of robotic device has emerged that uses an individual's muscle activation and stepping movements to control the robot during walking. This adaptive robotic device adjusts to the user's intentions and can assist with stepping during locomotor training in a manner that matches natural human stepping. While this type of adaptive robot has been preliminarily tested, the safety and efficacy of locomotor training using adaptive robotics are not well-established in patients with SCI. This is a critical step to determine if individuals with SCI may benefit from use of this device and for preliminary adoption of this technology. Recent studies have used the Cyberdyne Hybrid Assistive Limb (HAL) to deliver locomotor training and have reported outcomes suggesting that the HAL adaptive robot is safe and efficacious for walking rehabilitation in European SCI patients. Therefore this study will use the HAL adaptive robot to deliver locomotor training. This research is necessary to determine if use of the HAL is potentially beneficial and warranted for use with locomotor training and SCI patients receiving care in the U.S. Results of this study may contribute to the development and implementation of effective walking rehabilitation approaches for people with SCIs.
The group in the trial
- Locomotor training using adaptive robotTreatment being tested
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: Hybrid Assistive Limb (HAL)
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 19 October 2026