Clinical trial NCT02560506: Development of Low Cost Devices to Increase Access to Treadmill Training
Official title: Development of Low Cost Devices to Increase Access to Treadmill Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injury
Lead sponsor: Shirley Ryan AbilityLab
Sponsor class: OTHER
First posted: 2015-09-25
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: The investigators will develop and assess the use of spring-loaded devices to assist limb swing and forward propulsion during body weight supported treadmill training (BWSTT) (Aim 1). Prototype models of both devices have been developed.

These devices will be:

1. simple to use in the clinical setting;
2. will be easily adjustable to alter the assistance provided; and,
3. will be able to quantify the amount of assistance necessary to facilitate normal stepping patterns.

The investigators will also evaluate short- and long-term adaptations in locomotor performance following BWSTT in individuals with incomplete SCI with the use of these devices. This information will identify the effects of variable assistance at the limbs or trunk to modulate muscle activity and/or motor performance (kinematics) during stepping to maximize walking recovery.

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

Primary outcomes:
measure: Change in locomotor performance during treadmill walking
timeFrame: outcomes will be assessed prior to and following up to 8 weeks of training
Secondary outcomes:
measure: Change in oxygen consumption
timeFrame: outcomes will be assessed prior to and following up to 8 weeks of training
Other outcomes:
measure: Changes in overground gait speed
timeFrame: outcomes will be assessed prior to and following up to 8 weeks of training
Locations:
city: Chicago
country: United States
facility: Rehabilitation Institute of Chicago
state: Illinois
Study officials:
affiliation: Shirley Ryan AbilityLab
name: Thomas G Hornby, PhD
role: PRINCIPAL_INVESTIGATOR
References: