N/A
N=11
High Intensity Training for Neurological Injury Using Overground Exoskeletons in Inpatient Rehabilitation
Spinal Cord Injuries
Bottom Line
View on ClinicalTrials.gov: NCT04973852 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Apr 2026
Primary outcome: Primary: Percentage of Heart Rate Readings Within the Target Zone Achieved During HIT Gait Training Session — 72.67 Percentage of readings
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Ekso (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The University of Texas Health Science Center, Houston
- Primary completion
- May 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Heart Rate Readings Within the Target Zone Achieved During HIT Gait Training Session |
80.75 | — |
| PRIMARY Percentage of Heart Rate Readings Within the Target Zone Achieved During HIT Gait Training Session |
80.75 | — |
| PRIMARY Percentage of Heart Rate Readings Within the Target Zone Achieved During HIT Gait Training Session |
80.75 | — |
| PRIMARY Percentage of Heart Rate Readings Within the Target Zone Achieved During HIT Gait Training Session |
80.75 | — |
| PRIMARY Percentage of Heart Rate Readings Within the Target Zone Achieved During HIT Gait Training Session |
80.75 | — |
| PRIMARY Change in Self Selected Gait Speed as Assessed by the 10 Meter Walk Test (10MWT) |
0.09 | — |
| PRIMARY Change in Fast Gait Speed as Assessed by the 10 Meter Walk Test (10MWT) |
0.18 | — |
| PRIMARY Change in Walking Endurance as Assessed by the 6 Minute Walk Test (6MWT) |
81.66 | — |
| SECONDARY Change in Seated Dynamic Reach as Assessed by the Modified Functional Reach Test |
1.98 | — |
| SECONDARY Change in Spatial-Temporal Gait Parameters as Assessed by the GAITRite Pressure Map (Step Length Parameter) |
5.5 | — |
| SECONDARY Change in Spatial-Temporal Gait Parameters as Assessed by the GAITRite Pressure Map (Stride Length Parameter) |
9.5 | — |
| SECONDARY Change in Spatial-Temporal Gait Parameters as Assessed by the GAITRite Pressure Map (Single Support Parameter) |
-0.02 | — |
| SECONDARY Change in Spatial-Temporal Gait Parameters as Assessed by the GAITRite Pressure Map (Double Support Parameter) |
0.15 | — |
| SECONDARY Change in Spatial-Temporal Gait Parameters as Assessed by the GAITRite Pressure Map (Swing Time Parameter) |
0.05 | — |
| SECONDARY Change in Spatial-Temporal Gait Parameters as Assessed by the GAITRite Pressure Map (Stance Time Parameter) |
0.22 | — |
| SECONDARY Change in Spatial-Temporal Gait Parameters as Assessed by the GAITRite Pressure Map (Heel to Heel Base of Support Time Parameter) |
-1.83 | — |
| SECONDARY Change in Metabolic Expenditure During 10MWT, as Assessed by Oxygen Consumption |
— | — |
| SECONDARY Change in Metabolic Expenditure During 6MWT, as Assessed by Oxygen Consumption |
0.44 | — |
Summary
The purpose of this study is to see if it's possible to reach high cardiovascular intensity training parameters (exercise at a rate that elevates heart rate to the level recommended for improving strength and endurance) while walking in a wearable robotic exoskeleton. This study will also evaluate if exercising at high intensity will lead to improvement in walking ability. Participants in this study will be asked to attend 5 walking training sessions using Ekso exoskeleton. There will be two additional sessions, one before and one after the five training sessions. At these two sessions, study participants will be asked to participate in seated balance, walking speed and endurance tests and breathing assessments.
Eligibility Criteria
Inclusion Criteria
- Able to achieve adequate fit within the exoskeleton
- Diagnosis of CVA or motor incomplete SCI (AIS C or D)
- Sufficient range of motion to attain normal, reciprocal gait pattern, and transition from normal sit to stand or stand to sit
- Intact skin on all surfaces in contact with device and load-bearing surfaces
- Weight 10° at hips, knees, or ankles)
- Uncontrolled autonomic dysreflexia
- Unresolved deep vein thrombosis
- Inability to tolerate standing due to cardiovascular issues or orthostatic hypotension
- Inability to follow 3 step commands
- Severe comorbidities: active infections, heart, lung, or circulatory conditions
- Pressure sores, impaired skin integrity
- Use of mechanical ventilation for respiratory support
Data sourced from ClinicalTrials.gov (NCT04973852). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.