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Robotic Gait Training

Robotic Gait Training for Spinal Cord Injury (DOOR SCI Trial)

N/A
Recruiting
Led By Chad Swank, PhD, PT, NCS
Research Sponsored by Baylor Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
All types of motor incomplete SCI (traumatic and non-traumatic)
Undergoing medical care and rehabilitation at Baylor Scott & White Institute for Rehabilitation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 9 months
Awards & highlights

DOOR SCI Trial Summary

This trial is studying how well two treatments, robotic gait training and transcranial magnetic stimulation, work when started during inpatient rehabilitation and continued through early outpatient rehabilitation.

Who is the study for?
This trial is for individuals with motor incomplete spinal cord injuries, in the acute or subacute recovery phase. Participants must be medically stable and receiving care at Baylor Scott & White Institute for Rehabilitation. They should fit within the Ekso robotic exoskeleton's size limits and manage bladder/bowel continence. Exclusions include severe TBI, degenerative conditions, cognitive impairments, pregnancy, or living over 90 miles from the institute.Check my eligibility
What is being tested?
The DOOR SCI study is testing how different amounts of robotic gait training (RGT) combined with transcranial magnetic stimulation (TMS) affect functional outcomes and brain changes after a spinal cord injury. This happens during inpatient rehab and continues into early outpatient care.See study design
What are the potential side effects?
Potential side effects may include discomfort or skin irritation from wearing the robotic exoskeleton, fatigue due to exercise during gait training sessions, mild headaches or scalp sensations from TMS, but individual experiences can vary.

DOOR SCI Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have an incomplete spinal cord injury that affects my movement.
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I am receiving care at Baylor Scott & White Institute for Rehabilitation.
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My gender or ethnicity does not limit my participation.
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I can control my bladder and bowel or am following a management program.
Select...
I have an incomplete spinal cord injury that affects my movement.

DOOR SCI Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 9 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 9 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Walking Index for Spinal Cord Injury - II (WISCI-II) from baseline
Secondary outcome measures
Change in 10-Meter Walk Test (10MWT)
Change in Fatigue Severity Scale (FSS)
Change in Life Satisfaction Questionnaire (LISAT)
+6 more
Other outcome measures
Rate of adverse events
Rate of treatment completion
Self-reported tolerance of treatment

DOOR SCI Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Moderate FrequencyExperimental Treatment1 Intervention
Subjects will receive 3 sessions of robotic gait training (RGT) per week for 8 weeks
Group II: Low FrequencyExperimental Treatment1 Intervention
Subjects will receive 2 sessions of robotic gait training (RGT) per week for 12 weeks
Group III: High FrequencyExperimental Treatment1 Intervention
Subjects will receive 4 sessions of robotic gait training (RGT) per week for 6 weeks
Group IV: Control GroupActive Control1 Intervention
Subjects will receive usual care gait training without robotic gait training

Find a Location

Who is running the clinical trial?

Baylor Research InstituteLead Sponsor
198 Previous Clinical Trials
202,608 Total Patients Enrolled
United States Department of DefenseFED
858 Previous Clinical Trials
225,477 Total Patients Enrolled
Texas Woman's UniversityOTHER
86 Previous Clinical Trials
5,736 Total Patients Enrolled

Media Library

Robotic Gait Training (Robotic Gait Training) Clinical Trial Eligibility Overview. Trial Name: NCT05218447 — N/A
Spinal Cord Injury Research Study Groups: Low Frequency, Moderate Frequency, High Frequency, Control Group
Spinal Cord Injury Clinical Trial 2023: Robotic Gait Training Highlights & Side Effects. Trial Name: NCT05218447 — N/A
Robotic Gait Training (Robotic Gait Training) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05218447 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current enrollment of participants for this trial?

"Indeed, clinicaltrials.gov reveals that recruitment for this clinical trial is still ongoing since its initial posting on May 20th 2022 and latest update on June 20th 2022. The research needs to enlist 144 patients from one particular center."

Answered by AI

Is this research undertaking enrolling individuals who are over twenty years old?

"For individuals to be considered for this trial, they must fall under the age range of 16-85. Additionally, there are 138 studies seeking those younger than 18 and 735 specifically targeting senior citizens."

Answered by AI

Does my eligibility criteria qualify me to join the experiment?

"This clinical trial seeks 144 people with spinal cord injuries aged 16 to 85 years old. Applicants must qualify by demonstrating a motor incomplete SCI (traumatic or non-traumatic), be in the acute/subacute stage of recovery, and medically stable according to their doctor's assessment. They should also receive medical care from Baylor Scott & White Institute for Rehabilitation, have no gender or racial restrictions, satisfy Ekso robotic exoskeleton frame limitations, and demonstrate proper bladder and bowel management techniques."

Answered by AI

Are there any openings left to join this research project?

"According to the clinicaltrials.gov site, this clinical trial is actively recruiting participants. The study was initially made public on May 20th 2022 and has since been updated June 20th 2022."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
Baylor Scott & White Institute for Rehabilitation
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

Recent research and studies
~78 spots leftby Jun 2026