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NCT Number: NCT07553923

High-intensity Walking Rehabilitation in Outpatient Subacute Spinal Cord Injury

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Glenrose Rehabilitation Hospital

Edmonton, Alberta, T5G 0B7, Canada

Location status: Recruiting

Location contact

Caitlin Hurd, PhD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High-intensity Rehabilitation

Behavioral

Participants will receive high-intensity physical therapy intervention

Usual Care

Behavioral

Usual care physical therapy

Other names: Walking rehabilitation

Primary outcomes

  1. Change from Baseline in the Ten Metre Walk Test

    Time frame: Baseline and end of rehabilitation (up to 12 weeks following baseline)

    Time to walk ten metres; lower times indicate faster walking speed

Secondary outcomes

  1. 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)

    Distance walked in six minutes; longer distances indicate greater walking endurance

  2. Change from Baseline in the Timed Up and Go

    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

  3. 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)

    Participants are timed while completing four walking-related tasks; lower times indicate greater walking ability

  4. Change from Baseline in Motor-Evoked Potentials (MEPs)

    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.

Other outcomes

  1. Patient and Clinician Perspectives

    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.

  2. Change from Baseline in Daily Activity

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Caitlin Hurd, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Collaborators

  • Alberta Paraplegic foundation

Registry information

Official study title

High-intensity Walking Rehabilitation in Outpatient Subacute Spinal Cord Injury Rehabilitation: An Effectiveness-implementation Hybrid Study

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 28, 2026
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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