High-intensity Walking Rehabilitation in Outpatient Subacute Spinal Cord Injury

NCT07553923 | Not Yet Recruiting

• 1 other identifier: Pro0000159991
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

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

Conditions

Spinal Cord Injuries (SCI)

Keywords

high-intensity; subacute; walking; physical therapy

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (4)

• Change from Baseline in the Six Minute Walk Test with Physiological Cost Index

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

• Change from Baseline in the Timed Up and Go

  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)

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

• Change from Baseline in Motor-Evoked Potentials (MEPs)

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

Other Outcomes (1)

• Patient and Clinician Perspectives

  Within one month of the end of rehabilitation (maximum of 16 weeks from entry to the study)

Study Arms (2)

Usual Care

ACTIVE COMPARATOR

Participants will receive usual physical therapy intervention

Behavioral: Usual Care

High-intensity Rehabilitation

EXPERIMENTAL

Participants will receive high-intensity physical therapy intervention

Behavioral: High-intensity Rehabilitation

Interventions

High-intensity Rehabilitation BEHAVIORAL

Participants will receive high-intensity physical therapy intervention

High-intensity Rehabilitation

Usual Care BEHAVIORAL

Usual care physical therapy

Also known as: Walking rehabilitation

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alberta: lead
• Alberta Paraplegic foundation: collaborator

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2026
• First Posted: April 28, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share