Glenrose Rehabilitation Hospital
Edmonton, Alberta, T5G 0B7, Canada
Location status: Recruiting
NCT Number: NCT07553923
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
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Edmonton, Alberta, T5G 0B7, Canada
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will receive high-intensity physical therapy intervention
Usual care physical therapy
Other names: Walking rehabilitation
Time frame: Baseline and end of rehabilitation (up to 12 weeks following baseline)
Time to walk ten metres; lower times indicate faster walking speed
Time frame: Baseline and end of rehabilitation (up to 12 weeks following baseline)
Distance walked in six minutes; longer distances indicate greater walking endurance
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: Within one month of the end of rehabilitation (maximum of 16 weeks from entry to the study)
Semi-structured interviews will be conducted to explore participants' perspectives on high-intensity walking rehabilitation.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
University of Alberta
Other
High-intensity Walking Rehabilitation in Outpatient Subacute Spinal Cord Injury Rehabilitation: An Effectiveness-implementation Hybrid Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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