N/A
N=19
Development of Low Cost Devices to Increase Access to Treadmill Training
Spinal Cord Injury
Bottom Line
View on ClinicalTrials.gov: NCT02560506 ↗Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Apr 2026
Primary outcome: Primary: Change in Locomotor Performance During Treadmill Walking — 0.8 m/s
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Elastic assisted treadmill walking (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Shirley Ryan AbilityLab
- Primary completion
- Sep 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Locomotor Performance During Treadmill Walking |
0.8 | — |
| SECONDARY Gait Kinematics |
0.84 | — |
Summary
The goals of this Model System Program are to expand upon and advance the findings and outcomes of previous and current Model Systems clinical research, to continue to develop and study the effectiveness of innovative treatment strategies for persons with spinal cord injury (SCI); and to evaluate the benefits of a well-designed, comprehensive, coordinated, interdisciplinary continuum of care that lead to improved outcomes for all persons with SCI. In order to achieve these goals, the following objectives of the Midwest Regional Spinal Cord Injury Care System (MRSCICS) model system grant proposal will be accomplished.
Eligibility Criteria
Inclusion Criteria
- non-progressive lesion between spinal levels C1-T10 of > 3 months duration. Subjects with below T10 will be excluded due to potential lower motor neuron (LMN) injury
- score > 10 on the Lower Extremity Motor Score (LEMS) developed previously to measure strength in SCI. For the LEMS criteria, preliminary data indicate that subjects with LEMS < 10 in the chronic stages do not recover walking
- All subjects must require physical assistance to ambulate on the treadmill at a speed of 4.0 kmph at 0% body weight support (BWS)
- All subjects will have an overground gait speed <.8m/s
- range of motion (ankle: -10 to 30 deg, knee: 0 to 90 deg, hip: -10 to 40 deg) consistent with gait
- medically stable with medical clearance to participate (absence of concurrent illness, including unhealed decubiti, infection, cardiopulmonary disease, osteoporosis, active heterotrophic ossification or peripheral nerve damage in the lower limbs, history of traumatic head injury)
- able to tolerate 30 minutes of upright (standing) position without orthostasis (decrease in blood pressure by 20 mmHg systolic and 10 mmHg diastolic; minimized with ambulatory population)
- women of childbearing potential
Exclusion Criteria
- women who are pregnant will be excluded due to potential forces at trunk from BWS or pelvic assistance
- those in concurrent physical therapy to eliminate effects of additional interventions
Data sourced from ClinicalTrials.gov (NCT02560506). 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.