N/A
Completed N=19
Effects of Robotic Versus Manually-Assisted Locomotor Training for Individuals With Incomplete Spinal Cord Injury
Spinal Cord Injuries
Source: ClinicalTrials.gov NCT00127439 ↗
Enrolled (actual)
19
Serious AEs
5.3%
Results posted
Jan 2018
Primary outcomePrimary: Self Selected Velocity on Treadmill — 0.24; 0.22; 0.4; 0.39 m/s — p=0.05
Summary
The purpose of this study is to collect data comparing two means of providing locomotor training: manual and robotic and the possible differential effects it may have on walking ability for persons with spinal cord injury (SCI).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Self Selected Velocity on Treadmill |
0.24; 0.22; 0.4; 0.39 | 0.05 |
| PRIMARY Stepping: Foot Trajectory Toe-Off |
2.58; 0.92; 3.56; -0.58; -23.17; -38.87 | 0.05 |
| PRIMARY Stepping: Foot Trajectory Toe-off % Cycle |
-0.46; 4.51; -2.23; 1.02; 74.1; 85.66 | 0.05 |
| PRIMARY Foot Trajectory Initial Contact |
-2.57; -3.94; -2.99; -4.23; 0.71; -4.35 | 0.05 |
| PRIMARY Foot Trajectory Range (Toe Off to Heel Strike) |
2.14; -2.22; 3.12; -2.98; -10.06; -27.24 | 0.05 |
| PRIMARY Propulsion: Propulsive Impulse |
1.51; 7.76; 2.08; 7.12; 9.06; 15.97 | 0.05 |
| PRIMARY Kinematics: Minimum Thigh Angle |
1.45; -0.33; 1.54; -1.71; -6.9; -12.4 | 0.05 |
| PRIMARY Kinematics: Minimum Hip Angle - Extension |
0.11; -1.79; 0.74; -2.4; -0.09; -9.8 | 0.05 |
| PRIMARY Kinematics: Trunk Angle Mid-Stance |
-1.41; -0.72; -1.84; -0.72; -10.79; -8.01 | 0.05 |
Eligibility Criteria
Inclusion Criteria
- Adults at least 18 years of age
- Spinal cord injury (SCO) at least 6 months since injury
- Motor I-SCI, upper motor neuron lesion only at cervical or thoracic levels
- A diagnosis of first time SCI including etiology from trauma, vascular, or orthopedic pathology
- SCI as defined by the American ASIA Impairment Scale categories C or D
- Medically stable condition that is asymptomatic for bladder infection, decubiti, osteoporosis, cardiopulmonary disease, pain, contractures or other significant medical complications that would prohibit or interfere with testing of walking function and training or alter compliance with the training protocol
- Documented medical approval from the participant's personal physician verifying the participant's medical status at time of enrollment
- Ability to walk a minimum of 30 feet with or without an assistive device, independently or with minimal assistance
- Over ground gait speed < 0.8 m/s
- Persons using anti-spasticity medication must maintain stable medication dosage during the study
- Able to give informed consent
Exclusion Criteria
- Current participation in a rehabilitation program/research protocol that could interfere or influence the outcome measures of the current study
- History of congenital SCI (e.g. myelomeningocele, intraspinal neoplasm, Friedreich's ataxia) or other degenerative spinal disorders (e.g. spinocerebellar degeneration, syringomyelia) that may complicate the protocol
- Inappropriate or unsafe fit of the harness or robotic trainer due to the participant's body size and/or joint contractures or severe spasticity that would prohibit the safe provision of either training modality
Data sourced from ClinicalTrials.gov (NCT00127439). 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.