Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05218447

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

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

Age range

16 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baylor Scott & White Institute for Rehabilitation

Dallas, Texas, 75246, United States

About this study

Emerging evidence indicates that robotic exoskeleton use results in positive outcomes for those with chronic SCI, yet limited evidence exists for the acute setting. The potential benefit of RGT initiated during inpatient rehabilitation when recovery is greatest is unknown yet appears promising due to established principles of neuroplasticity and the fact that RGT incorporates the critical components of gait training. As a result of the lack of evidence, no clinical practice guidelines exist that delineate which gait retraining approach or dose during early phases of recovery results in the best outcomes for people with motor incomplete SCI. The DOOR SCI project examines dosing effects on 5 occasions over 9 months: (1) inpatient rehabilitation admission and (2) discharge, (3) after completing 24 RGT sessions, (4) 1-month post RGT, and (5) 9-months post SCI). To test the overarching goal, investigators propose three specific aims:

Aim 1: Using a randomized controlled trial, prospectively examine whether the dosing frequency [24 sessions delivered as high, moderate, or low frequency, defined by number days/week (4, 3, or 2 days/week over 6, 8, 12 weeks)] of RGT therapy provided during the acute/subacute recovery phase after motor incomplete SCI impacts outcomes compared to usual care only.

Aim 2: Investigate the difference over 9 months of the neuroplastic effect of RGT dosing as measured by single pulse TMS.

Aim 3: Evaluate the safety, tolerability, and feasibility of delivering different dosing frequencies of RGT from inpatient to outpatient rehabilitation settings.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

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.

Other names: Ekso GT™ robotic exoskeleton

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.

Primary outcomes

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

    Time frame: 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

    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.

Secondary outcomes

  1. Change in 10-Meter Walk Test (10MWT)

    Time frame: 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

    The 10MWT assesses gait speed (m/s) over a short duration.

  2. Change in Spinal Cord Independence Measure (SCIM)

    Time frame: 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

    The SCIM assesses the ability of a person with spinal cord injury (SCI) to preform specified tasks independently, with assistance, or with assistive devices.

    SCIM is composed of 19 items with total SCIM scores ranging from 0 (required assistance) to 100 (independence). A higher score means greater independence.

  3. Change in Numerical Pain Rating Scale (NPRS)

    Time frame: 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

    Pain is a significant problem in many individuals with SCI. A 0-10 Point Numerical Pain Rating Scale (NRS) is recommended as the outcome measure for pain intensity after SCI during acute and subacute phases. Pain severity can be categorized into 3 distinct groups as relates to pain interference: 1-3 (mild), 4-7 (moderate), 8-10 (severe). A higher score means greater pain severity.

  4. Change in Fatigue Severity Scale (FSS)

    Time frame: 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

    The Fatigue Severity Scale (FSS) is used to measure fatigue in neurologic disorders and measures the effects of fatigue on function. It is measure on the following scale:

    • - Strongly Disagree
    • - Disagree
    • - Slightly Disagree
    • - Neutral
    • - Slightly Agree
    • - Agree
    • - Strongly Agree A higher score means greater fatigue.

  5. Change in Penn Spasm Frequency Scale (PSFS)

    Time frame: 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

    The PSFS is a self-report measure to assess a patient's perception of spasticity frequency and severity following a SCI. With excellent internal consistency (ICC = 0.90), the current version was modified from the original to include both frequency and severity. A higher score means greater magnitude in spasms.

  6. Change in Patient Health Questionnaire - 9 (PHQ-9)

    Time frame: 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

    The PHQ-9 is a self-report measure to assess the presence of depressive symptoms. Each items is scored on the following scale:

    0 - not at all

    • - several days
    • - more than half the days
    • - nearly daily

    Total scores are calculated by adding all the score and provides a possible depression severity score:

    none (0-4), mild (5-9), moderate (10-14), moderately severe (15-19), and severe (20-27). A higher score means greater severity in depressive symptoms.

  7. Change in Life Satisfaction Questionnaire (LISAT)

    Time frame: 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

    The LISAT is a nine-item quality of life questionnaire suitable for SCI populations containing a single item assessing overall life satisfaction, along with eight additional domain-specific items. Items are answered on a 6-point likert scale that ranges from 1 (very dissatisfied), to 6 (very satisfied). The total Life Satisfaction score is computed as the mean of the item scores and the results are divided into dissatisfied (1-4) and satisfied (5-6). A higher score score means greater life satisfaction.

  8. Change in Physical Activity by GT9x Actigraph accelerometer

    Time frame: 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

    Active energy expenditure will be measured in counts per day using a GT9x Actigraph accelerometer. Patient will be instructed to wear the watch on an unaffected wrist for one week. Higher counts represent greater physical activity.

  9. Change in Neurophysiologic biomarkers by single pulse transcranial magnetic stimulation (TMS)

    Time frame: 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

    Motor evoked potential (MEP) amplitudes will be measured and indexed from lower extremity muscle by single pulse transcranial magnetic stimulation (TMS).

Other outcomes

  1. Rate of adverse events

    Time frame: Through study completion, an average of 9 months

    Number of adverse events occurring at baseline through study completion.

  2. Self-reported tolerance of treatment

    Time frame: Through study completion, an average of 9 months

    Subjects provide feedback on their tolerance of treatment sessions via an 18-item questionnaire. The questionnaire measures tolerability on a scale 0 (Not tolerable at all to 10 (Maximally tolerable). A higher score means greater tolerability in robotic gait training.

  3. Rate of treatment completion

    Time frame: Through study completion, an average of 9 months

    The average number of session attended divided by the number of scheduled sessions.

Sponsors and collaborators

Lead sponsor

Baylor Research Institute

Other

Collaborators

  • Congressionally Directed Medical Research Programs
  • Texas Woman's University

Registry information

Acronym: DOORSCI

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Feb 1, 2022
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.