High-intensity Walking Rehabilitation in Outpatient Subacute Spinal Cord Injury
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: High-intensity Rehabilitation, Usual Care.
- Who it may be relevant to
- Registry conditions: Spinal Cord Injuries (SCI). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
High-intensity Walking Rehabilitation in Outpatient Subacute Spinal Cord Injury Rehabilitation: An Effectiveness-implementation Hybrid Study
Overview
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
- Behavioral High-intensity Rehabilitation
Participants will receive high-intensity physical therapy intervention - Behavioral Usual Care
Usual care physical therapy
Primary outcome measures
- Change from Baseline in the Ten Metre Walk Test [Time frame: Baseline and end of rehabilitation (up to 12 weeks following baseline)]
Secondary outcome measures (4)
- Change from Baseline in the Six Minute Walk Test with Physiological Cost Index [Time frame: Baseline and end of rehabilitation (up to 12 weeks following baseline)]
- Change from Baseline in the Timed Up and Go [Time frame: 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) [Time frame: Baseline and end of rehabilitation (up to 12 weeks following baseline)]
- Change from Baseline in Motor-Evoked Potentials (MEPs) [Time frame: Baseline and end of rehabilitation (up to 12 weeks following baseline)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Canada · 1 center
- Glenrose Rehabilitation Hospital — Edmonton
Identifiers
NCT: NCT07553923 · Pro0000159991