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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Elastic assisted treadmill walking | Experimental | Participants will participate in treadmill training with a low cost pulley system device made of rubber bands (Theraband(R)), which will assist therapists in advancing limbs while gait training. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elastic assisted treadmill walking | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Locomotor Performance During Treadmill Walking | Evaluation of the changes in treadmill speed (m/s) prior to and following use of the device | change from Baseline in treadmill speed at 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Gait Kinematics | consistency of hip-knee angles | change from Baseline in treadmill speed at 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Overground Gait Speed | Gait speed (m/s) will be collected during overground walking | outcomes will be assessed prior to and following up to 8 weeks of training |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas G Hornby, PhD | Shirley Ryan AbilityLab | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rehabilitation Institute of Chicago | Chicago | Illinois | 60611 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Elastic Assisted Treadmill Walking | Participants will participate in treadmill training with a low cost pulley system device made of rubber bands (Theraband(R)), which will assist therapists in advancing limbs while gait training. Elastic 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Elastic Assisted Treadmill Walking | Participants will participate in treadmill training with a low cost pulley system device made of rubber bands (Theraband(R)), which will assist therapists in advancing limbs while gait training. Elastic 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | 18-64 years old used DOB |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Locomotor Performance During Treadmill Walking | Evaluation of the changes in treadmill speed (m/s) prior to and following use of the device | same as above | Posted | Mean | Standard Deviation | m/s | change from Baseline in treadmill speed at 8 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Elastic Assisted Treadmill Walking | Participants will participate in treadmill training with a low cost pulley system device made of rubber bands (Theraband(R)), which will assist therapists in advancing limbs while gait training. Elastic 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. T. George Hornby | Indiana University | 3123508291 | tghornby@iu.edu |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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|
|
| Count of Participants |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| peak treadmill speed | Mean | Standard Deviation | m/s |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Gait Kinematics | consistency of hip-knee angles | Posted | Mean | Standard Deviation | no units | change from Baseline in treadmill speed at 8 weeks |
|
|
|
| Other Pre-specified | Changes in Overground Gait Speed | Gait speed (m/s) will be collected during overground walking | Not Posted | outcomes will be assessed prior to and following up to 8 weeks of training | Participants |
| 0 |
| 19 |
| 0 |
| 19 |
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| D014947 | Wounds and Injuries |