Clinical trial NCT03011099: Improving Gait Performance in Individuals With Spinal Cord Injuries: an Intervention Using Robotic Exoskeletons
Official title: Improving Gait Performance in Individuals With Spinal Cord Injuries: an Intervention Using Robotic Exoskeletons
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2017-01-05
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.
* 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

Primary outcomes:
measure: Change in Over Ground Gait Speed as Assessed by the 10 Meter Walk Test
timeFrame: baseline, week 4
measure: Change in Walking Endurance as Assessed by the 6 Minute Walk Test
timeFrame: baseline, week 4
measure: Change in Dynamic Mobility Assessment as Determined by the Timed Up and Go Test
timeFrame: baseline, week 4
measure: Change in Muscle Activity as Assessed by Surface Electromyography (EMG)
timeFrame: baseline, week 4
measure: Change in Energy Expenditure During Walking as Assessed by Oxygen Cost
timeFrame: baseline, week 4
Secondary outcomes:
measure: Change in Gait Characteristics as Assessed by the GAITRite Walkway (Cadence)
timeFrame: baseline, week 4
measure: Change in Gait Characteristics as Assessed by the GAITRite Walkway (Step Length)
timeFrame: baseline, week 4
measure: Change in Gait Characteristics as Assessed by the GAITRite Walkway (Step Time)
timeFrame: baseline, week 4
measure: Change in Lower Extremity Strength as Assessed by American Spinal Injury Association (ASIA) Lower Extremity Motor Score (LEMS)
timeFrame: baseline, week 4
measure: Exoskeleton User Feedback as Assessed by a Questionnaire
timeFrame: week 4
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Matthew Davis, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chang SH, Afzal T; TIRR SCI Clinical Exoskeleton Group; Berliner J, Francisco GE. Exoskeleton-assisted gait training to improve gait in individuals with spinal cord injury: a pilot randomized study. Pilot Feasibility Stud. 2018 Mar 5;4:62. doi: 10.1186/s40814-018-0247-y. eCollection 2018.