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

The University of Texas Health Science Center, Houston12 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Spinal Cord Injuries

Interventions

Robotic exoskeleton trainingDEVICE

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.

Conventional physical therapyOTHER

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Outcomes

Primary Outcomes

Change in Over Ground Gait Speed as Assessed by the 10 Meter Walk Test

The 10 Meter Walk Test assesses the time taken to walk 10 meters.

Time frame: baseline, week 4

Change in Walking Endurance as Assessed by the 6 Minute Walk Test

The 6 Minute Walk Test assesses the distance walked in 6 minutes.

Time frame: baseline, week 4

Change in Dynamic Mobility Assessment as Determined by the Timed Up and Go Test

The Timed Up and Go test assessed the time it takes to stand from a sitting position, complete a 3 meter walk, and then return to sitting.

Time frame: baseline, week 4

Change in Muscle Activity as Assessed by Surface Electromyography (EMG)

Surface EMG sensors will be placed on the skin of subjects' lower extremities and trunk to measure muscle activity. Only one participant data was analyzed. Emg was recorded from the soleus, gastrocnemius, tibialis anterior, rectus femoris, vastus medialis, bicep femoris and semitendinosus muscles. The outcome measure is the %age change between the baseline and 4 week assessments. Negative values denotes decrease in muscle activity at 4 week compared to baseline.

Time frame: baseline, week 4

Change in Energy Expenditure During Walking as Assessed by Oxygen Cost

Oxygen cost will be calculated from oxygen consumption as the product of gait speed and body weight.20 Oxygen consumption will be calculated on a breath-by-breath basis measured by a portable metabolic system (Cosmed K4b2).

Time frame: baseline, week 4

Secondary Outcomes

Change in Gait Characteristics as Assessed by the GAITRite Walkway (Cadence)

Gait quality will be measured with the GAITRite Walkway which can quantify step cadence, step length, step time, double support time, and symmetry. Cadence is measured as steps/min. Change in cadence is reported as difference between baseline and post assessment.

Data from ClinicalTrials.gov

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