Spinal Cord Injury
Conditions
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.
Interventions
DEVICEElastic assisted treadmill walking
Rubber band pulley system that will assist therapists in advancing limbs while gait training. The device is positioned in front of a treadmill and the stretch of the elastic bands when a legs moves backwards on a treadmill is resists the movement and facilitates limb swing when walking.
Sponsors
Shirley Ryan AbilityLab
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Locomotor Performance During Treadmill Walking | change from Baseline in treadmill speed at 8 weeks | Evaluation of the changes in treadmill speed (m/s) prior to and following use of the device |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gait Kinematics | change from Baseline in treadmill speed at 8 weeks | consistency of hip-knee angles |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORThomas G Hornby, PhD
Shirley Ryan AbilityLab
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants |
| Age, Continuous | 43 years STANDARD_DEVIATION 19 |
| peak treadmill speed | .64 m/s STANDARD_DEVIATION 0.26 |
| Region of Enrollment United States | 19 participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| other Total, other adverse events | 0 / 19 |
| serious Total, serious adverse events | 0 / 19 |
Outcome results
None listed