Improving Gait Performance in Individuals With Spinal Cord Injuries: an Intervention Using Robotic Exoskeletons

The University of Texas System (UT)

Status: Completed

Conditions: Spinal Cord Injuries

Treatments: Other: Conventional physical therapy; Device: Robotic exoskeleton training

Study type: Interventional

Funder types: Other

Identifiers

NCT03011099

HSC-MS-13-0536

Details and patient eligibility

About

The purpose of this study is to investigate whether robotic exoskeleton training can improve walking performance after SCI as compared to conventional physical therapy.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Motor Incomplete spinal cord injury, as classified by American Spinal Injury Association guidelines, above the lumbar level (T12 and above).
• Able to independently stand for two minutes with or without an assistive device and with or without orthoses distal to the knee.
• Male or non-pregnant woman
• ≥ 18-years of age
• At least 6 months after injury
• Height between 5'2" and 6'2" (150-188 cm)
• Weight ≤ 220 pounds (100 kg)
• Ability to perform informed consent

Exclusion criteria

• Presence of clinical signs of lower motor neuron injury
• History of severe neurologic injuries other than SCI (MS, CP, ALS, TBI, CVA, etc.)
• Severe comorbidities: active infections, heart, lung, or circulatory conditions, pressure ulcers.
• Documented severe osteoporosis affecting the hip and spine
• Severe spasticity in the lower extremities (Modified Ashworth ≥ 3) or uncontrolled clonus
• Unstable spine
• Unhealed limb or pelvic fractures
• Skin issues that would prevent wearing the device
• Range of motion restrictions that would prevent subject from achieving a normal, reciprocal gait pattern, or would restrict a subject from completing normal sit to stand or stand to sit transitions.
• Upper extremity strength deficits that limit ability to balance with a front rolling walker or crutches.
• Heterotopic ossification that resists functional range of motion in lower extremities
• Contractures (>15 degrees at the hips or >20 degrees at the knees)
• Psychiatric or cognitive comorbidities resulting in motor planning or impulsivity concerns
• Colostomy
• Have received any physical therapy intervention within 3 months prior to enrolment in the study
• Non-English speaking

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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12 participants in 2 patient groups

Robotic exoskeleton training

Experimental group

Description:

During the training, subjects will wear a lower extremity exoskeleton robotic walking device. Subjects will participate in individualized treatment sessions which may include: sit to stand, static and dynamic standing balance, weight shifting, walking, turning, and stand to sit. Each training session will last up to 90 minutes (60 minutes of training with 30 minutes for setup, don/doff of device) and training will be held 5 days per week for 3 weeks with a total of 15 sessions. During the training period, subjects will be required to maintain the same amount and level of regular daily physical activity and exercise.

Treatment:

Device: Robotic exoskeleton training

Conventional Physical Therapy

Active Comparator group

Description:

During the training, subjects will receive conventional physical therapy that is designed to facilitate/promote gait. This will include individualized treatment sessions for each subject and may involve stretching, strengthening, balance training, standing, and gait training. Subjects will not be able to participate in any form of robotic assisted or body weight supported treadmill training. Each training session will last up to 60 minutes and training will be held 5 days per week for 3 weeks with a total of 15 sessions. Consistent with the RET group, subjects will be required to maintain the same amount and level of regular daily physical activity and exercise during study period.

Treatment:

Other: Conventional physical therapy