Dosing of Overground Robotic Gait Training with Functional Outcomes and Neuroplasticity After Spinal Cord Injury

NCT05218447 | Recruiting DMC FDA Device

• 1 other identifier: BSWRI IRB 021-205
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

The DOOR SCI project examines dosing effects of robotic gait training (RGT) and transcranial magnetic stimulation (TMS) initiated during inpatient rehabilitation and continued through early outpatient rehabilitation

Conditions

Spinal Cord Injuries

Keywords

Exoskeleton; Wearable assistive technology; Transcranial magnetic stimulation; Robotic gait training

Outcome Measures

Primary Outcomes (1)

• Change in Walking Index for Spinal Cord Injury - II (WISCI-II) from baseline

  The 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. The 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.

  Change in baseline, within 5 days of discharge, within 5 days post-intervention (RGT Groups) or 1-month post-discharge (UC group), 1-month post-intervention or 2-months post-discharge (UC group) (5) 9-months post-SCI onset

Secondary Outcomes (9)

• Change in 10-Meter Walk Test (10MWT)

  Change in baseline, within 5 days of discharge, within 5 days post-intervention (RGT Groups) or 1-month post-discharge (UC group), 1-month post-intervention or 2-months post-discharge (UC group) (5) 9-months post-SCI onset

• Change in Spinal Cord Independence Measure (SCIM)

  Change in baseline, within 5 days of discharge, within 5 days post-intervention (RGT Groups) or 1-month post-discharge (UC group), 1-month post-intervention or 2-months post-discharge (UC group) (5) 9-months post-SCI onset

• Change in Numerical Pain Rating Scale (NPRS)

  Change in baseline, within 5 days of discharge, within 5 days post-intervention (RGT Groups) or 1-month post-discharge (UC group), 1-month post-intervention or 2-months post-discharge (UC group) (5) 9-months post-SCI onset

• Change in Fatigue Severity Scale (FSS)

  Change in baseline, within 5 days of discharge, within 5 days post-intervention (RGT Groups) or 1-month post-discharge (UC group), 1-month post-intervention or 2-months post-discharge (UC group) (5) 9-months post-SCI onset

• Change in Penn Spasm Frequency Scale (PSFS)

  Change in baseline, within 5 days of discharge, within 5 days post-intervention (RGT Groups) or 1-month post-discharge (UC group), 1-month post-intervention or 2-months post-discharge (UC group) (5) 9-months post-SCI onset

Other Outcomes (3)

• Rate of adverse events

  Through study completion, an average of 9 months

• Self-reported tolerance of treatment

  Through study completion, an average of 9 months

• Rate of treatment completion

  Through study completion, an average of 9 months

Study Arms (4)

Low Frequency

EXPERIMENTAL

Subjects will receive 2 sessions of robotic gait training (RGT) per week for 12 weeks

Device: Robotic Gait Training

Moderate Frequency

EXPERIMENTAL

Subjects will receive 3 sessions of robotic gait training (RGT) per week for 8 weeks

Device: Robotic Gait Training

High Frequency

EXPERIMENTAL

Subjects will receive 4 sessions of robotic gait training (RGT) per week for 6 weeks

Device: Robotic Gait Training

Control Group

ACTIVE COMPARATOR

Subjects will receive usual care gait training without robotic gait training

Other: Usual Care (UC) Gait Training

Interventions

Robotic Gait Training DEVICE

Subjects will be randomized to one of 4 gait training group. The duration of treatment will span across their inpatient rehabilitation length of stay after providing informed consent to their 9 months post-SCI visit in the outpatient rehabilitation setting. Subjects will wear an exoskeleton device and receive robotic gait training (RGT) with a physical therapist during a 45-minutes inpatient rehabilitation session. Subjects will complete 24 robotic gait training sessions over different durations during outpatient rehabilitation. Subjects will also complete a transcranial magnetic stimulation (TMS) assessment and questionnaires about walking and function. Subjects will be asked to wear an activity monitor to measure their activity.

Also known as: Ekso GT™ robotic exoskeleton

High Frequency; Low Frequency; Moderate Frequency

Usual Care (UC) Gait Training OTHER

Subjects will be randomized to one of 4 gait training group. The duration of treatment will span across their inpatient rehabilitation length of stay after providing informed consent to their 9 months post-SCI visit in the outpatient rehabilitation setting. Subjects will complete gait training with a physical therapist during a 45-minutes inpatient rehabilitation session. Subjects will also complete a transcranial magnetic stimulation (TMS) assessment and questionnaires about walking and function. Subjects will be asked to wear an activity monitor to measure their activity.

Control Group

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:

• All types of motor incomplete SCI (traumatic and non-traumatic)
• Acute/Subacute phase of recovery
• Medically stable as deemed by physician
• Undergoing medical care and rehabilitation at Baylor Scott \& White Institute for Rehabilitation
• 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:

• Concurrent moderate to severe traumatic brain injury (TBI)
• Degenerative diagnoses
• Pre-morbid developmental disability, significant psychological diagnosis, or other cognitive impairment
• Pregnancy

Sponsors & Collaborators

• Baylor Research Institute: lead
• United States Department of Defense: collaborator
• Texas Woman's University: collaborator

Study Sites (1)

Baylor Scott & White Institute for Rehabilitation

Dallas, Texas, 75246, United States

RECRUITING

Related Publications (5)

• Swank C, Trammell M, Bennett M, Ochoa C, Callender L, Sikka S, Driver S. The utilization of an overground robotic exoskeleton for gait training during inpatient rehabilitation-single-center retrospective findings. Int J Rehabil Res. 2020 Sep;43(3):206-213. doi: 10.1097/MRR.0000000000000409.

  PMID: 32282573 BACKGROUND

• Swank C, Sikka S, Driver S, Bennett M, Callender L. Feasibility of integrating robotic exoskeleton gait training in inpatient rehabilitation. Disabil Rehabil Assist Technol. 2020 May;15(4):409-417. doi: 10.1080/17483107.2019.1587014. Epub 2019 Mar 19.

  PMID: 30887864 BACKGROUND

• DiPasquale J, Trammell M, Clark K, Fowler H, Callender L, Bennett M, Swank C. Intensity of usual care physical therapy during inpatient rehabilitation for people with neurologic diagnoses. PM R. 2022 Jan;14(1):46-57. doi: 10.1002/pmrj.12577. Epub 2021 Apr 15.

  PMID: 33599119 BACKGROUND

• Swank C, Galvan C, DiPasquale J, Callender L, Sikka S, & Driver D. Lessons Learned with Robotic Exoskeleton Use During Rehabilitation - therapeutic and medical severity considerations. Technology & Disability. 2020; 32(2): 103-110.

  BACKGROUND

• Suhalka A, da Silva Areas FZ, Meza F, Ochoa C, Driver S, Sikka S, Hamilton R, Goh HT, Callender L, Bennett M, Shih HT, Swank C. Dosing overground robotic gait training after spinal cord injury: a randomized clinical trial protocol. Trials. 2024 Oct 18;25(1):690. doi: 10.1186/s13063-024-08503-0.

  PMID: 39425122 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

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

Study Officials

• Chad Swank, PhD, PT, NCS

  Baylor Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Faith Meza, MPH

CONTACT

469-531-1577; Faith.Meza@BSWHealth.org

Christa Ochoa, MPH

CONTACT

Christa.Ochoa@BSWHealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All clinical and study specific assessments will be completed by trained assessors blinded to group allocation. Clinical assessments will be completed by a physical therapist (e.g., WISCI-II, SCIM). Study specific assessments (e.g., FSS, actigraphy, TMS) will be conducted by study staff and investigator. Subjects will not be blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Investigator

Model Details: Subjects will be randomly assigned into one of 4 gait training groups: usual care (UC) gait training only; high frequency RGT - 4 sessions/week for 6 weeks; moderate frequency RGT - 3 sessions/week for 8 weeks; or low frequency RGT - 2 sessions/week for 12 weeks

Study Record Dates

• First Submitted: December 20, 2021
• First Posted: February 1, 2022
• Study Start: May 20, 2022
• Primary Completion: June 14, 2025
• Study Completion: September 14, 2025
• Last Updated: February 6, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)