Spinal Cord Injuries (SCI)
Conditions
Keywords
high-intensity, subacute, walking, physical therapy
Brief summary
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: * Does high-intensity walking rehabilitation improve walking ability, compared to usual care for individuals with subacute spinal cord injury? * What are some of the barriers and facilitators to delivering high-intensity walking rehabilitation in an outpatient setting? 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: * Attend regular outpatient physical therapy sessions focused on walking rehabilitation * Receive either usual care or a higher-intensity walking program delivered by their physical therapist * Have their activities, heart rate, step counts, and self-reported effort during therapy sessions monitored * Complete walking, balance, and neurophysiological assessments at the start and end of rehabilitation * Wear an activity monitor for one week at the beginning and end of the study to measure daily activity outside of therapy * Participants who receive the higher-intensity intervention may participate in an interview to share their experiences with rehabilitation
Interventions
BEHAVIORALHigh-intensity Rehabilitation
Participants will receive high-intensity physical therapy intervention
BEHAVIORALUsual Care
Usual care physical therapy
Sponsors
University of Alberta
Alberta Paraplegic foundation
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult (≥ 18 years of age) * Sustained a SCI within the past year * Motor incomplete SCI - classified as American Spinal Injury Association (ASIA) Impairment Scale levels C or D * Able to stand and initiate reciprocal steps through voluntary lower extremity movement but may require maximal physical assistance of at least one person and may include assistive devices (SWAT level 2A or above) * Indicate a walking-related goal on admission to outpatient physical therapy
Exclusion criteria
* Medical or movement restriction(s) that limit high-intensity standing or walking rehabilitation (e.g., weight bearing restriction to lower extremities, cardiovascular constraints) * Inability to understand or communicate verbally in English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in the Ten Metre Walk Test | Baseline and end of rehabilitation (up to 12 weeks following baseline) | Time to walk ten metres; lower times indicate faster walking speed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in the Six Minute Walk Test with Physiological Cost Index | Baseline and end of rehabilitation (up to 12 weeks following baseline) | Distance walked in six minutes; longer distances indicate greater walking endurance |
| Change from Baseline in the Timed Up and Go | Baseline and end of rehabilitation (up to 12 weeks following baseline) | Time taken to stand, walk 3 metres and return to sitting position; longer time indicates balance and mobility impairments |
| Change from Baseline in the Modified Spinal Cord Injury Functional Ambulation Profile (mSCI-FAP) | Baseline and end of rehabilitation (up to 12 weeks following baseline) | Participants are timed while completing four walking-related tasks; lower times indicate greater walking ability |
| Change from Baseline in Motor-Evoked Potentials (MEPs) | Baseline and end of rehabilitation (up to 12 weeks following baseline) | Transcranial magnetic stimulation (TMS) will be used and MEPs will be measured in lower extremity muscles. Size and latency of MEPs will be measured. |
Countries
Canada
Contacts
CONTACTCaitlin Hurd, PhD
Outcome results
None listed