Development of Low Cost Devices to Increase Access to Treadmill Training

Completed · Not applicable

Conditions studied: Spinal Cord Injury

In brief

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.

Key facts

Study ID

NCT02560506

Run by

Shirley Ryan AbilityLab

People needed

19

Starts

2008-01-01

Expected to finish

2016-09-01

Last updated by the study team

2026-04-27

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Rehabilitation Institute of Chicago — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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