High-intensity Walking Rehabilitation in Outpatient Subacute Spinal Cord Injury
ConditionSpinal Cord Injuries (SCI)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Alberta
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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 design
Design model
Sequential
Treatments tested in this trial
High-intensity Rehabilitation
BehavioralParticipants will receive high-intensity physical therapy intervention
Usual Care
BehavioralUsual care physical therapy
Treatment groups
25 Participants
are divided into 2 treatment groupsGroup A: Usual CareActive comparator 1 intervention
Group B: High-intensity RehabilitationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change from Baseline in the Ten Metre Walk Test
Time to walk ten metres; lower times indicate faster walking speed
Time frame
Baseline and end of rehabilitation (up to 12 weeks following baseline)Secondary outcomes
1
Change from Baseline in the Six Minute Walk Test with Physiological Cost Index
Distance walked in six minutes; longer distances indicate greater walking endurance
Time frame
Baseline and end of rehabilitation (up to 12 weeks following baseline)2
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
Time frame
Baseline and end of rehabilitation (up to 12 weeks following baseline)3
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
Time frame
Baseline and end of rehabilitation (up to 12 weeks following baseline)4
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.
Time frame
Baseline and end of rehabilitation (up to 12 weeks following baseline)Other outcomes
1
Patient and Clinician Perspectives
Semi-structured interviews will be conducted to explore participants' perspectives on high-intensity walking rehabilitation.
Time frame
Within one month of the end of rehabilitation (maximum of 16 weeks from entry to the study)2
Change from Baseline in Daily Activity
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.
Time frame
Baseline and end of rehabilitation (up to 12 weeks following baseline)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Alberta
Lead sponsor
Alberta Paraplegic foundation
Collaborator
Source ClinicalTrials.gov