Walking Rehabilitation After Spinal Cord Injury: Locomotor Training Using Adaptive Robotics

NCT03504826 | Active Not Recruiting FDA Device

• 1 other identifier: 2017-02655
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Spinal Cord Injuries

Keywords

adaptive robotics; locomotor training; Spinal Cord diseases; walking rehabilitation; Spinal Cord Injury

Outcome Measures

Primary Outcomes (2)

• 10-Meter Walk Test (10MWT)

  Performance assessment of comfortable and fastest safe walking speed for 10 meters. A reduced time (in seconds) to complete the 10-Meter Walk Test reflects improvement in walking function.

  Daily and change in baseline to weeks 6 and 12

• 6-Minute Walk Test (6MWT)

  Performance assessment of walking endurance for 6 minutes. An increase in the number of meters walked during this assessment reflects an improvement in walking endurance.

  Daily and change in baseline to weeks 6 and 12

Secondary Outcomes (1)

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

  Change in baseline to week 12

Study Arms (1)

Locomotor training using adaptive robot

EXPERIMENTAL

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.

Device: Hybrid Assistive Limb (HAL)

Interventions

Hybrid Assistive Limb (HAL) DEVICE

Intensive training with the HAL consisting of two components to the intervention session that include: 1) locomotor treadmill training with the HAL device and 2) locomotor training over ground without the HAL device. All training will be overseen by a licensed physical therapist.

Locomotor training using adaptive robot

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• Legal blindness or severe visual impairment
• Known pregnancy
• Pacemaker or medical device implants which may interfere with the use of the HAL

Sponsors & Collaborators

• Brooks Rehabilitation: lead
• University of Florida: collaborator

Study Sites (1)

Brooks Rehabilitation

Jacksonville, Florida, 32216, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Spinal Cord Diseases

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Emily J Fox, DPT, PhD

  Brooks Rehabilitation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2018
• First Posted: April 20, 2018
• Study Start: November 29, 2018
• Primary Completion: July 1, 2024
• Study Completion: December 1, 2024
• Last Updated: April 2, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)