Improving Gait Performance in Individuals With Spinal Cord Injuries: an Intervention Using Robotic Exoskeletons
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Spinal Cord Injuries
- Sponsor
- The University of Texas Health Science Center, Houston
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Change in Over Ground Gait Speed as Assessed by the 10 Meter Walk Test
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
The purpose of this study is to investigate whether robotic exoskeleton training can improve walking performance after SCI as compared to conventional physical therapy.
Investigators
Matthew Edward Davis
Assistant Professor
The University of Texas Health Science Center, Houston
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Change in Over Ground Gait Speed as Assessed by the 10 Meter Walk Test
Time Frame: baseline, week 4
The 10 Meter Walk Test assesses the time taken to walk 10 meters.
Change in Walking Endurance as Assessed by the 6 Minute Walk Test
Time Frame: baseline, week 4
The 6 Minute Walk Test assesses the distance walked in 6 minutes.
Change in Dynamic Mobility Assessment as Determined by the Timed Up and Go Test
Time Frame: baseline, week 4
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.
Change in Muscle Activity as Assessed by Surface Electromyography (EMG)
Time Frame: baseline, week 4
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.
Change in Energy Expenditure During Walking as Assessed by Oxygen Cost
Time Frame: baseline, week 4
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).
Secondary Outcomes
- Change in Gait Characteristics as Assessed by the GAITRite Walkway (Cadence)(baseline, week 4)
- Change in Gait Characteristics as Assessed by the GAITRite Walkway (Step Length)(baseline, week 4)
- Change in Gait Characteristics as Assessed by the GAITRite Walkway (Step Time)(baseline, week 4)
- Change in Lower Extremity Strength as Assessed by American Spinal Injury Association (ASIA) Lower Extremity Motor Score (LEMS)(baseline, week 4)
- Exoskeleton User Feedback as Assessed by a Questionnaire(week 4)