High Intensity Training for Neurological Injury Using Overground Exoskeletons in Inpatient Rehabilitation (HIT Exo IP)

The University of Texas System (UT)

Status

Enrolling

Conditions

Spinal Cord Injuries

Treatments

Device: Ekso

Study type

Interventional

Funder types

Other

Identifiers

NCT04973852

HSC-MS-21-0262

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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