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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 range18 Years

SexALL

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…

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