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View on ClinicalTrials.gov

Testing High-intensity Rehabilitation for spinal cord injuries (SCI)

Official title: High-intensity Walking Rehabilitation in Outpatient Subacute Spinal Cord Injury

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

Condition: Spinal Cord Injuries (SCI)Sponsor: University of AlbertaTarget enrollment: 25
  • 2 groups
  • One site, in Edmonton
  • Recruiting
Glenrose Rehabilitation Hospital, Edmonton, Alberta

Interventions

  • Behavioural therapy

    High-intensity Rehabilitation

    Participants will receive high-intensity physical therapy intervention

  • Behavioural therapy

    Usual Care

    Usual care physical therapy

Canadian Sites (1)

1 of 1 recruiting

  • Glenrose Rehabilitation Hospital

    Edmonton, Alberta

    Recruiting

Eligibility Criteria

See who this study is looking for7 criteria

The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.

Inclusion

  • +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

  • 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
5 concepts to explore on this page · up to 1,300 pointsTap any term to learn what it means.

In plain language

Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.

Learning 
What this study is

This study is testing a treatment for a condition.

This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.

From the trial registry

Built from these fields:

  • designModule.designInfo.primaryPurpose
  • designModule.phases
Who receives what

There are 2 groups in this study.

Group A, the comparison group, receives Usual CareStandard of careThe treatment normally given for a condition outside a study.Read more →.

Registry label: A: Usual Care

Group B receives High-intensity Rehabilitation.

Registry label: B: High-intensity Rehabilitation

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].label
  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
How the study is run

Groups are assigned by the study team using set rules, rather than by chance.

This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.

From the trial registry

Built from these fields:

  • designModule.designInfo.allocation
  • designModule.designInfo.maskingInfo.masking
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

One group receives an existing treatment, so the two can be compared.

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for

The study lists a minimum age of 18 years, with no upper limit given.

The study is open to people of any sex.

The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.

These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.

From the trial registry

Built from these fields:

  • eligibilityModule.minimumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How big and how long

The study aims to enrol about 25 people.

The study is currently expected to finish around October 2027.

The main measurement is taken over: BaselineBaselineYour starting measurements, taken before treatment begins.Read more → and end of rehabilitation (up to 12 weeks following baseline).

From the trial registry

Built from these fields:

  • designModule.enrollmentInfo.count
  • statusModule.completionDateStruct.date
  • outcomesModule.primaryOutcomes[].timeFrame
What the study measures

Change from BaselineBaselineYour starting measurements, taken before treatment begins.Read more → in the Ten Metre Walk Test — measured over Baseline and end of rehabilitation (up to 12 weeks following baseline).

From the trial registry

Built from these fields:

  • outcomesModule.primaryOutcomes[].measure
  • outcomesModule.primaryOutcomes[].timeFrame

Source: NCT07553923 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.

Not medical advice. What do these terms mean?

What is being tested — in plain terms

About High-intensity RehabilitationBehavioural

Participants will receive high-intensity physical therapy intervention

From the trial registry — its own words, unedited.

What a behavioural is here: A programme, therapy, education, or lifestyle approach being studied.

Read the full explanation → · in clinical review

About Usual CareBehavioural

Usual care physical therapy

From the trial registry — its own words, unedited.

What a behavioural is here: A programme, therapy, education, or lifestyle approach being studied.

Read the full explanation → · in clinical review

Common questions

Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.

Am I eligible for this trial?

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.

What the study lists: a minimum age of 18 years.

The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.

The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.eligibilityCriteria
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

One group receives an existing treatment so the two can be compared.

From the trial registry
  • armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?

This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.

Groups are assigned by the study team using set rules, rather than by chance.

From the trial registry
  • designModule.designInfo.maskingInfo.masking
  • designModule.designInfo.allocation
Who can join?

The study lists a minimum age of 18 years, with no upper limit given.

It is open to people of any sex.

It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How long would this take?

The study's main measurement is taken over: BaselineBaselineYour starting measurements, taken before treatment begins.Read more → and end of rehabilitation (up to 12 weeks following baseline).

The study as a whole is currently expected to finish around 2027-10.

How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.

From the trial registry
  • outcomesModule.primaryOutcomes[].timeFrame
  • statusModule.completionDateStruct.date
How many people are taking part?

The study aims to enrol about 25 people.

From the trial registry
  • designModule.enrollmentInfo.count
Where is this happening?

This study lists one location: Edmonton, Alberta, Canada.

Sites can open and close during a study, so confirm with the team before travelling.

From the trial registry
  • trial_locations

About This Trial

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

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This page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.