Spinal Cord Injuries (SCI)NCT07553923
High-intensity Walking Rehabilitation in Outpatient Subacute Spinal Cord Injury
A study testing High-intensity Rehabilitation in people with Spinal Cord Injuries (SCI), run by University of Alberta at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries (SCI)
- What is being tested?
- High-intensity Rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteCanada
- Study dates
- 26 May 2026to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Caitlin Hurd, PhD contact
Canada1 site, 1 recruiting
- Recruiting
Glenrose Rehabilitation Hospital
Edmonton, Alberta, T5G 0B7
Caitlin Hurd, PhD, clhurd@ualberta.ca
About this study
Official title: High-intensity Walking Rehabilitation in Outpatient Subacute Spinal Cord Injury Rehabilitation: An Effectiveness-implementation Hybrid Study
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:
Read more
- 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)
- Being tested
- High-intensity Rehabilitation, Usual Care
- Keywords
- high-intensity, subacute, walking, physical therapy
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-intensity RehabilitationBehavioural
Participants will receive high-intensity physical therapy intervention
Usual CareBehavioural
Also called Walking rehabilitation
Usual care physical therapy
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Active comparator | Participants will receive usual physical therapy intervention Receives: Behavioral: Usual Care |
| High-intensity Rehabilitation | Experimental | Participants will receive high-intensity physical therapy intervention Receives: Behavioral: High-intensity Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in the Ten Metre Walk Test
Time to walk ten metres; lower times indicate faster walking speed
Measured: 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
Distance walked in six minutes; longer distances indicate greater walking endurance
Measured: Baseline and end of rehabilitation (up to 12 weeks following baseline)
Change from Baseline in the Timed Up and Go
Time taken to stand, walk 3 metres and return to sitting position; longer time indicates balance and mobility impairments
Measured: 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)
Participants are timed while completing four walking-related tasks; lower times indicate greater walking ability
Measured: Baseline and end of rehabilitation (up to 12 weeks following baseline)
Change from Baseline in Motor-Evoked Potentials (MEPs)
Transcranial magnetic stimulation (TMS) will be used and MEPs will be measured in lower extremity muscles. Size and latency of MEPs will be measured.
Measured: Baseline and end of rehabilitation (up to 12 weeks following baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2026
- Study start26 May 2026
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord Injuries (SCI)Studies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Alberta Paraplegic foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07553923
- Sponsor's protocol ID
- Pro0000159991
- Status last verified
- Jun 2026
- First submitted
- 14 Apr 2026
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-intensity Walking Rehabilitation in Outpatient Subacute Spinal Cord Injury Rehabilitation: An Effectiveness-implementation Hybrid Study
- ClinicalTrials.gov ID
- NCT07553923
- Acronym / sponsor ID
- Pro0000159991
- Conditions
- Spinal Cord Injuries (SCI)
- Keywords
- high-intensity, subacute, walking, physical therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Alberta Paraplegic foundation
- Study start
- 26 May 2026 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 28 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Active comparator | Behavioral: Usual CareParticipants will receive usual physical therapy intervention |
| High-intensity Rehabilitation | Experimental | Behavioral: High-intensity RehabilitationParticipants will receive high-intensity physical therapy intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-intensity RehabilitationParticipants will receive high-intensity physical therapy intervention | Behavioural | High-intensity Rehabilitation |
| Usual CareAlso: Walking rehabilitationUsual care physical therapy | Behavioural | Usual Care |
Primary outcome
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
4 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Caitlin Hurd, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-intensity Rehabilitation in people with Spinal Cord Injuries (SCI), run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Caitlin Hurd, PhD (clhurd@ualberta.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in the Ten Metre Walk Test (time frame: Baseline and end of rehabilitation (up to 12 weeks following baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.