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| ID | Type | Description | Link |
|---|---|---|---|
| CDMRP- SC220241 | Other Grant/Funding Number | CDMRP |
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| Name | Class |
|---|---|
| Baylor Scott and White Health | OTHER |
| University of Florida | OTHER |
| Congressionally Directed Medical Research Programs | FED |
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The purpose of this study is to evaluate if a specific type of additional walking therapy, called body weight supported treadmill training (BWSTT) affects walking ability following a traumatic spinal cord injury. Specifically, the study will look at whether starting BWSTT, which uses a body harness to support body weight while walking on a treadmill at different times within the first 6 months after the injury, makes a difference in how effective this therapy may be, While we know that the brain re-learns patterns following an injury, there has not been a lot of prior research evaluating how starting this type of walking therapy at specific times within the first 6 months after injury may impact any effectiveness of the additional therapy.
The study will randomize participants into four groups: those who start this therapy within 60 days, within 3 months, within 6 months or who do not receive this additional research therapy. Randomization means that which group you will be in as part of this study is determined by chance, like the flip of a coin. The additional walking therapy for this research study, if you are randomized for one of the three groups who receives the additional therapy, will be given on top of (meaning in addition to) any standard of care therapies that you may be receiving at that time point after your injury.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early Intervention | Active Comparator | Additional training will begin no more than 60 days following spinal cord injury |
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| Sub-acute Intervention | Active Comparator | Additional training will occur 3 months following spinal cord injury |
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| Chronic Intervention | Active Comparator | Additional training will occur 6-12 months following SCI |
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| Standard of Care | No Intervention | This group only receives standard of care treatment but is assessed at the same time points as the other groups |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Body Weight Supported Treadmill Training | Procedure | For these training sessions, participants will undergo walking training sessions that consist of wearing a harness for either body weight support or as a safety precaution while walking on a treadmill. |
| Measure | Description | Time Frame |
|---|---|---|
| 10 Meter walk test | Used to assess walking speed, time taken to walk 10 meters at fastest pace | 1-5 days Following Intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 6 Minute Walk test | Used to assess distance traveled during a 6 minute walking test at a self selected pace | 1-5 days Following Intervention |
| Walking Index for spinal cord injury | Assessment to determine the physical assistance and assistive devices needed to walk 10 meters |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexander Barry, MS, CCRC | Contact | 3122381435 | abarry@sralab.org |
| Name | Affiliation | Role |
|---|---|---|
| Milap Sandhu, PhD | Shirley Ryan AbilityLab | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Shirley Ryan AbilityLab | Recruiting | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39702102 | Derived | Henry M, Coxe RC, Barry A, O'Donnell A, Kessler A, Shan G, Swank C, Rymer WZ, Sandhu MS. A research protocol to study the critical time window for rehabilitation after incomplete spinal cord injury: early vs. late locomotor training. BMC Neurol. 2024 Dec 19;24(1):482. doi: 10.1186/s12883-024-03980-x. |
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We are not currently planning to make individual participant data available to other researchers
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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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Participants will be randomized into one of 4 intervention groups, based around if and when additional walking training is given following injury
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Investigator and outcome assessor will have no knowledge of groups, cannot blind participants as they know when they will be receiving the additional training
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| 1-5 days following intervention |
| Daily step counts | Step counts from a waist worn activity tracker | 2 weeks following 3-, 6-, 9-, and 12- month assessments |
| Gait Deviation idex | A measure of gait quality by quantifying joint angles during a gait cycle. This data is recorded via a marker-less motion capture system | Baseline, 3-, 6-, 9-, and 12- month assessments |
| Baylor Scott and White Institute for Rehabilitation | Not yet recruiting | Fort Worth | Texas | 76132 | United States |
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| D014947 | Wounds and Injuries |