UnknownNot Applicable

Algorithmic-Based Evaluation and Treatment Approach for Robotic Gait Training

United States75 participantsStarted 2016-03

Plain-language summary

The purpose of this study is to develop an algorithmic-based evaluation and treatment approach for wearable robotic exoskeleton (WRE) gait training for patients with neurological conditions.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Spinal Cord Injury Inclusion Criteria: * Male or non-pregnant female * ≥18 years of age * Chronic (\> 6 mo post) injury * Diagnosis of spinal cord injury * Able to achieve adequate fit within exoskeleton * Sufficient range of motion to attain normal, reciprocal gait pattern, and transition from normal sit to stand or stand to sit * Weight \<220 pounds * Intact skin on all surfaces in contact with device and load bearing surfaces * Ability to perform informed consent * Cognitively intact and able to follow directions and demonstrate learning capability Spinal Cord Injury Exclusion Criteria: * Pregnancy * Spinal instability * Non-English speaking * Unhealed limb or pelvic fractures or any condition restricting weight bearing in limbs * Diagnosis of other neurological injury other than SCI such as CVA, MS, ABI, CP * Uncontrolled spasticity (≥3 on Modified Ashworth Scale)\[21\] * Colostomy * Decreased range of motion or contractures in legs (\>10° at hips, knees or ankles) * Uncontrolled autonomic dysreflexia * Unresolved deep vein thrombosis * Inability to tolerate standing due to cardiovascular issues or orthostatic hypotension * Severe comorbidities: active infections, heart, lung, or circulatory conditions * Pressure sores, impaired skin integrity Acquired Brain Injury(ABI) Inclusion Criteria: * Male or non-pregnant female * ≥18 years of age * Chronic (\> 6 mo post) injury * Able to achieve adequate fit within exoskeleton * Ability to perform informed consent * Sufficien…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in over ground gait speed as assessed by the 10 Meter Walk Test without WRE

Timeframe: within one week before start of WRE training, within 2 weeks after start of WRE training

Change in walking endurance as assessed by the 6 Minute Walk Test without WRE

Timeframe: within one week before start of WRE training, within 2 weeks after start of WRE training

Change in muscle activity as assessed by electromyography (EMG) during 10MWT without WRE

Timeframe: within one week before start of WRE training, within 2 weeks after start of WRE training

Change in muscle activity as assessed by electromyography (EMG) during 6MWT without WRE

Timeframe: within one week before start of WRE training, within 2 weeks after start of WRE training

Change in energy expenditure as assessed by oxygen consumption during 10MWT without WRE

Timeframe: within one week before start of WRE training, within 2 weeks after start of WRE training

Change in energy expenditure as assessed by oxygen consumption during 6MWT without WRE

Timeframe: within one week before start of WRE training, within 2 weeks after start of WRE training

Trial details

NCT IDNCT03057652

SponsorThe University of Texas Health Science Center, Houston

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12

Contact for this trial

Shuo-Hsiu Chang, PT, PhD

713-799-7016 shuo-hsiu.chang@uth.tmc.edu

View on ClinicalTrials.gov More Complete Spinal Cord Injury trials