Foundational Ingredients of Robotic Gait Training for People With Spinal Cord Injury During Inpatient Therapy

NCT04781621 | Completed DMC FDA Device

• 1 other identifier: 020-483
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

Brief Summary

The FIRST project compares the dose of robotic gait training (RGT) with usual care gait training for patients with spinal cord injury (SCI) undergoing rehabilitation at Baylor Scott \& White Institute for Rehabilitation (BSWIR).

Conditions

Spinal Cord Injuries

Keywords

Gait Training; Exoskeleton; Physical Therapy; Physical Rehabilitation and Medicine; Inpatient Rehabilitation; Robotic Gait Training; Randomized Control Trial

Outcome Measures

Primary Outcomes (1)

• Walking Index for Spinal Cord Injury - II (WISCI-II)

  WISCI-II defines the physical limitation for gait secondary to impairment at the person level and indicates the ability of a person to walk after SCI. WISC-II rank orders the ability a person to walk on a scale of 0-20 with 0 representing no ability to stand or participate in assisted walking and 20 representing an ability to walk 10 meters with no devices, no braces, and no physical assistance.

  Within one week before discharge

Secondary Outcomes (12)

• Gait speed via 10-Meter Walk Test (10MWT)

  Within one week of admission before start of treatment; Within one week before discharge

• Spinal Cord Independence Measure (SCIM)

  Within one week of admission before start of treatment; Within one week before discharge

• Numerical Pain Rating Scale (NPRS)

  Within one week of admission before start of treatment; Within one week before discharge

• Fatigue Severity Scale (FSS)

  Within one week of admission before start of treatment; Within one week before discharge

• Penn Spasm Frequency Scale (PSFS)

  Within one week of admission before start of treatment; Within one week before discharge

Study Arms (2)

Robotic Gait Training

EXPERIMENTAL

Patients in the Robotic Gait Training (RGT) group will receive 90 minutes per week of RGT once patients are deemed clinically appropriate as defined by being able to tolerate standing for 15 minutes without orthostatic intolerance. The duration of treatment will span the patient's length of stay in inpatient rehabilitation. The Ekso Bionics Ekso GT™ robotic exoskeleton will be used for RGT.

Device: Robotic Gait Training

Usual Care Gait Training

ACTIVE COMPARATOR

Usual Care (UC) gait training including body weight-supported treadmill training (BWSTT) and conventional overground walking.

Other: Usual Care Gait Training

Interventions

Robotic Gait Training DEVICE

Participants will wear an exoskeleton suit and receive robotic gait training with a physical therapist for 90 minutes each week. Robot gait training will include standing and walking activities while wearing the The Ekso Bionics Ekso GT™ robotic exoskeleton. Participants will be asked to complete questionnaires about walking and function. They will also be asked to wear a watch measuring their heart rate monitor.

Also known as: EksoGT™ robotic exoskeleton

Robotic Gait Training

Usual Care Gait Training OTHER

Participants receive usual care gait training with a physical therapist for 90 minutes each week. Usual care gait training includes standard gait training involving standing and walking activities such as conventional overground walking, body weight-supported treadmill training (BWSTT), overground body weight-supported overground system, and various assistive devices (e.g., BWSTT, overground with braces, walker, etc.). Participants will be asked to complete questionnaires about walking and function. They will also be asked to wear a watch measuring their heart rate monitor and number of steps.

Also known as: Standard of Care Gait Training; body-weight support treadmill training (BWSTT); Overground gait training with braces,

Usual Care Gait Training

Eligibility Criteria

• Age: 16 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Years of Age
• All types of incomplete Spinal Cord Injury (SCI) (traumatic and non-traumatic)
• Acute/Subacute phase of recovery
• Medically stable as deemed by physician
• Undergoing medical care and inpatient rehabilitation at BSW
• Both genders and all races and ethnicities
• Meet the Ekso robotic exoskeleton frame limitations
• Continence of or a program for bladder and bowel management

You may not qualify if:

• Moderate to Severe Traumatic Brain Injury (TBI)
• Degenerative diagnoses
• Wound located in proximity to the exoskeleton frame
• Severe osteoporosis/-penia as shown with dual energy x-ray absorptiometry (DXA)
• Pre-morbid developmental disability, significant psychological diagnosis, or other cognitive impairment

Sponsors & Collaborators

• Baylor Research Institute: lead
• National Institute on Disability, Independent Living, and Rehabilitation Research: collaborator

Study Sites (1)

Baylor Scott & White Institute for Rehabilitation

Dallas, Texas, 75246, United States

Location

Related Publications (1)

• Swank C, Holden A, McDonald L, Driver S, Callender L, Bennett M, Sikka S. Foundational ingredients of robotic gait training for people with incomplete spinal cord injury during inpatient rehabilitation (FIRST): A randomized controlled trial protocol. PLoS One. 2022 May 10;17(5):e0267013. doi: 10.1371/journal.pone.0267013. eCollection 2022.

  PMID: 35536844 BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Braces

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Study Officials

• Seema Sikka, MD

  Baylor Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Control Trial. Patients are randomized into one of two groups: robotic exoskeleton gait training and usual care gait training.

Study Record Dates

• First Submitted: February 3, 2021
• First Posted: March 4, 2021
• Study Start: April 12, 2021
• Primary Completion: March 8, 2024
• Study Completion: March 8, 2024
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)