High Intensity Training for Neurological Injury Using Overground Exoskeletons in Inpatient Rehabilitation
Purpose
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.
Condition
- Spinal Cord Injuries
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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 <220 pounds
Exclusion Criteria
- Pregnancy - Spinal instability - Unhealed limb or pelvic fractures or any condition restricting weight-bearing in limbs - Diagnosis of other neurological injuries other than CVA or SCI - Uncontrolled spasticity (≥3 on Modified Ashworth Scale) - 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 - 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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Exoskeleton |
5 sessions of overground ambulation with wearable exoskeleton where heart rate is monitored over each session. |
|
Recruiting Locations
Houston, Texas 77030
James Chang
More Details
- Status
- Recruiting
- Sponsor
- The University of Texas Health Science Center, Houston
Detailed Description
The purpose of this study is to determine the feasibility and potential efficacy to implement high cardiovascular intensity training parameters (70-80% heart rate reserve) with the use of overground wearable robotic exoskeletons in an inpatient rehabilitation setting for locomotor recovery. The second aim is to investigate the potential functional improvements in gait after receiving high-intensity locomotor training with an overground exoskeleton, as measured on the 10-meter walk test and six-minute walk test.