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| Name | Class |
|---|---|
| Alberta Paraplegic foundation | UNKNOWN |
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People with incomplete spinal cord injury (SCI) often have some preserved movement and may regain walking ability, but recovery can be limited, and more effective rehabilitation approaches are needed.The goal of this clinical trial is to learn if high-intensity walking rehabilitation can improve walking recovery and overall neurological recovery in individuals with subacute SCI. The investigators are also exploring the process of incorporating this type of physical therapy approach in an outpatient rehabilitation setting.
The main questions it aims to answer are:
The investigators will compare usual care rehabilitation to a high-intensity rehabilitation program to see if higher-intensity physical therapy leads to better walking outcomes and improved recovery. The study will also explore how feasible it is to deliver this type of program in a real-world outpatient rehabilitation setting and gather perspectives from both participants and clinicians.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | Active Comparator | Participants will receive usual physical therapy intervention |
|
| High-intensity Rehabilitation | Experimental | Participants will receive high-intensity physical therapy intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-intensity Rehabilitation | Behavioral | Participants will receive high-intensity physical therapy intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in the Ten Metre Walk Test | Time to walk ten metres; lower times indicate faster walking speed | Baseline and end of rehabilitation (up to 12 weeks following baseline) |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in the Six Minute Walk Test with Physiological Cost Index | Distance walked in six minutes; longer distances indicate greater walking endurance | Baseline and end of rehabilitation (up to 12 weeks following baseline) |
| Change from Baseline in the Timed Up and Go |
| Measure | Description | Time Frame |
|---|---|---|
| Patient and Clinician Perspectives | Semi-structured interviews will be conducted to explore participants' perspectives on high-intensity walking rehabilitation. | Within one month of the end of rehabilitation (maximum of 16 weeks from entry to the study) |
| Change from Baseline in Daily Activity |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Caitlin Hurd, PhD | Contact | clhurd@ualberta.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Glenrose Rehabilitation Hospital | Recruiting | Edmonton | Alberta | T5G 0B7 | Canada |
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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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| Usual Care | Behavioral | Usual care physical therapy |
|
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Time taken to stand, walk 3 metres and return to sitting position; longer time indicates balance and mobility impairments |
| Baseline and end of rehabilitation (up to 12 weeks following baseline) |
| Change from Baseline in the Modified Spinal Cord Injury Functional Ambulation Profile (mSCI-FAP) | Participants are timed while completing four walking-related tasks; lower times indicate greater walking ability | Baseline and end of rehabilitation (up to 12 weeks following baseline) |
| Change from Baseline in Motor-Evoked Potentials (MEPs) | Transcranial magnetic stimulation (TMS) will be used and MEPs will be measured in lower extremity muscles. Size and latency of MEPs will be measured. | Baseline and end of rehabilitation (up to 12 weeks following baseline) |
Activity monitors will be used to measure daily activity levels (including daily step counts). Average activity over 4-7 days of monitoring will be calculated. |
| Baseline and end of rehabilitation (up to 12 weeks following baseline) |
| D014947 | Wounds and Injuries |