Spinal Cord InjuriesFIRSTNCT04781621
Foundational Ingredients of Robotic Gait Training for People With Spinal Cord Injury During Inpatient Therapy
A study testing Robotic Gait Training in people with Spinal Cord Injuries, run by Baylor Research Institute at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 16 to 85 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Robotic Gait Training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Apr 2021to 8 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 16 - 85 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Baylor Scott & White Institute for Rehabilitation
Dallas, Texas, 75246
About this study
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).
Read the detailed description
Spinal cord injury (SCI) due to trauma is estimated to affect 288,000 - 500,000 Americans, with about 17,700 new cases annually. Recovery of walking is a primary rehabilitation goal for patients and encouraged by therapists due to its relationship to quality of life, impact on health, psychological profile, and social participation after SCI. Recent technological advances with exoskeleton devices specifically for gait training may yield better walking recovery outcomes compared with usual care intervention approaches, such as body-weight support treadmill training (BWSTT) and overground gait training with braces, yet limited evidence exists for those with SCI.
Aim 1: Use a Community-Based Participatory Research approach to develop an robotic gait training (RGT) program that meets the unique needs of people after incomplete SCI during inpatient rehabilitation. This will be achieved by establishing and engaging an Advisory Board of key stakeholders to review evidence-based literature, advise the research team on the unique aspects and goals of inpatient rehabilitation for people with SCI, review the RGT, and make recommendations for amendments to the RGT program based on our interim and final outcomes of the study over the funding period.
Aim 2: Prospectively examine the efficacy of RGT compared to usual care gait training during inpatient rehabilitation in people with incomplete SCI.
Aim 3: Compare the intensity of RGT and usual care gait training during inpatient rehabilitation.
- Conditions
- Spinal Cord Injuries
- Being tested
- Robotic Gait Training, Usual Care Gait Training
- Keywords
- Gait Training, Exoskeleton, Physical Therapy, Physical Rehabilitation and Medicine, Inpatient Rehabilitation, Robotic Gait Training, Randomized Control Trial
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic Gait TrainingDevice
Also called EksoGT™ robotic exoskeleton
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.
Usual Care Gait TrainingOther
Also called Standard of Care Gait Training; body-weight support treadmill training (BWSTT); Overground gait training with braces,
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Usual Care Gait Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within one week before discharge
Secondary outcomes (12)
Gait speed via 10-Meter Walk Test (10MWT)
The 10MWT assesses gait speed (m/s) over a short duration.
Measured: Within one week of admission before start of treatment; Within one week before discharge
Spinal Cord Independence Measure (SCIM)
The SCIM assesses self-care management, respiration and sphincter management, and functional mobility after a SCI. SCIM is composed of 19 items with total SCIM scores ranging from 0 (required assistance) to 100 (independence).
Measured: Within one week of admission before start of treatment; Within one week before discharge
Numerical Pain Rating Scale (NPRS)
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).
Measured: Within one week of admission before start of treatment; Within one week before discharge
Fatigue Severity Scale (FSS)
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
Measured: Within one week of admission before start of treatment; Within one week before discharge
Penn Spasm Frequency Scale (PSFS)
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.
Measured: Within one week of admission before start of treatment; Within one week before discharge
Patient Health Questionnaire - 9 (PHQ-9)
The PHQ-9 is a self-report measure to assess the presence and intensity of depressive symptoms. For SCI, the PHQ-9 demonstrates excellent internal consistency (Chronbach's alpha = 0.87) and construct validity (r = 0.78).
Measured: Within one week of admission before start of treatment; Within one week before discharge
General Anxiety Disorder (GAD-7)
The GAD-7 is a self-report measure to assess the presence of anxiety. 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 score cutoffs for 5 (mild anxiety), 10 (moderate anxiety) and 15 (severe anxiety).
Measured: Within one week of admission before start of treatment; Within one week before discharge
International Spinal Cord Injury Quality of Life Basic Data Set
The International Spinal Cord Injury Quality of Life Basic Data Set is a three-item quality of life questionnaire suitable for SCI populations containing items assessing general life satisfaction, satisfaction with physical health, and satisfaction with psychological health. Items are answered on a 10-point likert scale that ranges from 0 (completely dissatisfied) to 10 (very satisfied).
Measured: Within one week of admission before start of treatment; Within one week before discharge
Heart Rate (HR)
Polar heart rate monitor (Polar® Unite) will provide data on the day, duration, and intensity (average and maximum) of gait training sessions for both RGT and UC. Participants will be provided a Polar heart rate monitor to wear during each gait training session for the entire length of the study, and gait training session data will be collected weekly. These monitors record beat to beat heart rates and store up to 16 sessions of heart rate data. Each week study staff will upload participants' heart rate data using Polar's FlowLink technology via the Polarpersonaltrainer.com website.
Measured: Immediately following every treatment until discharge, an average of 28 days
Ratings of Perceived Exertion (RPE)
The Borg RPE is a 15-point scale with verbal descriptors to standardize perceived exertion across tasks and individuals. Participants will be asked to provide a self-reported intensity level on the Borg Rating of Perceived Exertion Scale during RGT and UC gait training sessions. A self-report of 12 to 14 on the RPE indicates moderate intensity. The Borg RPE scale has been shown to be a valid measure of exercise intensity with weighted mean validity coefficient of 0.62 for HR.
Measured: Immediately following every treatment session until discharge, an average of 28 days
Number of Steps
The Ekso device records several data points for each session including number of steps, "Up" time (the amount of time spent standing in the device), "Walk" time (the amount of time spent walking in the device), and device assistance scores. While all of these data values will be recorded to describe each RGT session and tracked to monitor progression of the RGT intervention, the number of steps per session will be utilized as an indicator of RGT session intensity.42,91 We will consult our Consumer Advocates for recommendations on incorporating device scores such as "Up" time and "Walk" time as additional measures of intensity.
Number of steps for the UC group will be collected via pedometer during each gait training session. The number of steps captured on the device will be recorded on the case report form after each gait training session. The watch will be reset before each use.
Measured: Immediately following every treatment session until discharge, an average of 28 days
Patient Perceptual Survey
This survey contains six open-ended questions assessing participant perception and satisfaction with treatment as well as asking participants to describe observable changes in functional activities.
Measured: Within one week before discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2021
- Study start12 Apr 2021
- Primary completion8 Mar 2024
- Study completion8 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by Baylor Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Control Trial. Patients are randomized into one of two groups: robotic exoskeleton gait training and usual care gait training.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Disability, Independent Living, and Rehabilitation Research
- Responsible party
- Sponsor
- Investigators
- Seema Sikka, MD, Principal investigator, Baylor Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04781621
- Sponsor's protocol ID
- 020-483
- Acronym
- FIRST
- Status last verified
- Apr 2026
- First submitted
- 3 Feb 2021
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 35536844
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Foundational Ingredients of Robotic Gait Training for People With Spinal Cord Injury During Inpatient Therapy
- ClinicalTrials.gov ID
- NCT04781621
- Acronym / sponsor ID
- FIRST / 020-483
- Conditions
- Spinal Cord Injuries
- Keywords
- Gait Training, Exoskeleton, Physical Therapy, Physical Rehabilitation and Medicine, Inpatient Rehabilitation, Robotic Gait Training, Randomized Control Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Collaborators
- National Institute on Disability, Independent Living, and Rehabilitation Research
- Study start
- 12 Apr 2021 (actual)
- Primary completion
- 8 Mar 2024 (actual)
- Study completion
- 8 Mar 2024 (actual)
- First posted
- 4 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Spinal cord injury (SCI) due to trauma is estimated to affect 288,000 - 500,000 Americans, with about 17,700 new cases annually. Recovery of walking is a primary rehabilitation goal for patients and encouraged by therapists due to its relationship to quality of life, impact on health, psychological profile, and social participation after SCI. Recent technological advances with exoskeleton devices specifically for gait training may yield better walking recovery outcomes compared with usual care intervention approaches, such as body-weight support treadmill training (BWSTT) and overground gait training with braces, yet limited evidence exists for those with SCI.
Aim 1: Use a Community-Based Participatory Research approach to develop an robotic gait training (RGT) program that meets the unique needs of people after incomplete SCI during inpatient rehabilitation. This will be achieved by establishing and engaging an Advisory Board of key stakeholders to review evidence-based literature, advise the research team on the unique aspects and goals of inpatient rehabilitation for people with SCI, review the RGT, and make recommendations for amendments to the RGT program based on our interim and final outcomes of the study over the funding period.
Aim 2: Prospectively examine the efficacy of RGT compared to usual care gait training during inpatient rehabilitation in people with incomplete SCI.
Aim 3: Compare the intensity of RGT and usual care gait training during inpatient rehabilitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Control Trial. Patients are randomized into one of two groups: robotic exoskeleton gait training and usual care gait training.
| Arm | Type | Receives |
|---|---|---|
| Robotic Gait Training | Experimental | Device: Robotic Gait TrainingPatients 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. |
| Usual Care Gait Training | Active comparator | Other: Usual Care Gait TrainingUsual Care (UC) gait training including body weight-supported treadmill training (BWSTT) and conventional overground walking. |
Who may qualify
- Ages
- 16 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 16 - 85 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robotic Gait TrainingAlso: EksoGT™ robotic exoskeletonParticipants 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. | Device | Robotic Gait Training |
| Usual Care Gait TrainingAlso: Standard of Care Gait Training; body-weight support treadmill training (BWSTT); Overground gait training with braces,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. | Other | Usual Care Gait Training |
Primary outcome
Walking Index for Spinal Cord Injury - II (WISCI-II)
Time frame: Within one week before discharge
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.
12 secondary outcomes
Gait speed via 10-Meter Walk Test (10MWT)
Time frame: Within one week of admission before start of treatment; Within one week before discharge
Spinal Cord Independence Measure (SCIM)
Time frame: Within one week of admission before start of treatment; Within one week before discharge
Numerical Pain Rating Scale (NPRS)
Time frame: Within one week of admission before start of treatment; Within one week before discharge
Fatigue Severity Scale (FSS)
Time frame: Within one week of admission before start of treatment; Within one week before discharge
Penn Spasm Frequency Scale (PSFS)
Time frame: Within one week of admission before start of treatment; Within one week before discharge
Patient Health Questionnaire - 9 (PHQ-9)
Time frame: Within one week of admission before start of treatment; Within one week before discharge
General Anxiety Disorder (GAD-7)
Time frame: Within one week of admission before start of treatment; Within one week before discharge
International Spinal Cord Injury Quality of Life Basic Data Set
Time frame: Within one week of admission before start of treatment; Within one week before discharge
Heart Rate (HR)
Time frame: Immediately following every treatment until discharge, an average of 28 days
Ratings of Perceived Exertion (RPE)
Time frame: Immediately following every treatment session until discharge, an average of 28 days
Number of Steps
Time frame: Immediately following every treatment session until discharge, an average of 28 days
Patient Perceptual Survey
Time frame: Within one week before discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Background: PubMed 35536844Swank 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seema Sikka, MD principal investigator
Baylor Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic Gait Training in people with Spinal Cord Injuries, run by Baylor Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Walking Index for Spinal Cord Injury - II (WISCI-II) (time frame: Within one week before discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04781621, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.