N/A
Completed N=11
Improving Gait Performance in Individuals With Spinal Cord Injuries: an Intervention Using Robotic Exoskeletons
Spinal Cord Injuries
Source: ClinicalTrials.gov NCT03011099 ↗
Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Apr 2018
Primary outcomePrimary: Change in Over Ground Gait Speed as Assessed by the 10 Meter Walk Test — -6.815; -0.5 seconds
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Over Ground Gait Speed as Assessed by the 10 Meter Walk Test |
-6.815; -0.5 | — |
| PRIMARY Change in Walking Endurance as Assessed by the 6 Minute Walk Test |
34.3833; 25.3 | — |
| PRIMARY Change in Dynamic Mobility Assessment as Determined by the Timed Up and Go Test |
-10.575; -1.59 | — |
| PRIMARY Change in Muscle Activity as Assessed by Surface Electromyography (EMG) |
-44; -37; 57; 12; -18; 33 | — |
| PRIMARY Change in Energy Expenditure During Walking as Assessed by Oxygen Cost |
-0.84 | — |
| SECONDARY Change in Gait Characteristics as Assessed by the GAITRite Walkway (Cadence) |
0.12; 0.08 | — |
| SECONDARY Change in Gait Characteristics as Assessed by the GAITRite Walkway (Step Length) |
0.04; -0.03 | — |
| SECONDARY Change in Gait Characteristics as Assessed by the GAITRite Walkway (Step Time) |
-0.09; -0.02 | — |
| SECONDARY Change in Lower Extremity Strength as Assessed by American Spinal Injury Association (ASIA) Lower Extremity Motor Score (LEMS) |
0.42; -0.17 | — |
| SECONDARY Exoskeleton User Feedback as Assessed by a Questionnaire |
1.83 | — |
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
Data sourced from ClinicalTrials.gov (NCT03011099). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.