Spinal Cord Injuries (Complete and Incomplete), Spinal Cord Injuries (SCI), Spinal Cord Injuries and Disorders (SCI/D)
Conditions
Keywords
Transcutaneous Spinal Stimulation, Transcutaneous Spinal Cord Stimulation, Rehabilitation, Implementation Science, Feasibility Trial, Neuromodulation, Clinical Implementation, Acceptability
Brief summary
Transcutaneous spinal stimulation (TSS) is a non-invasive neuromodulation approach that delivers electrical stimulation to spinal nerve roots through electrodes placed over the spinal cord. TSS may support motor and functional recovery following spinal cord injury (SCI). However, therapeutic potential alone does not establish whether TSS can be feasibly integrated into routine rehabilitation. Clinical implementation introduces practical considerations including clinician training, device setup and operation, time, safety monitoring, acceptability, organizational resources, and compatibility with existing rehabilitation workflows. This study will evaluate the feasibility of integrating TSS into two existing SCI rehabilitation programs at Parkwood Institute: outpatient upper- and lower-extremity functional electrical stimulation (FES) cycling using the Xcite system with TSS functionality, and routine inpatient physiotherapy and occupational therapy using the Stim2Go device. Evaluating TSS across two rehabilitation contexts will identify setting-specific barriers, facilitators, and implementation requirements. The primary objective is to evaluate the feasibility, safety, acceptability, and implementation strategies required to integrate TSS into outpatient FES cycling and inpatient SCI rehabilitation. Secondary objectives are to explore preliminary changes in clinical and functional outcomes and synthesize implementation findings into evidence-informed recommendations for TSS implementation. A multi-methods, multi-intervention case series design will be used. Implementation will be guided by the Active Implementation Frameworks and a Training and Coaching Model. Feasibility will be evaluated using Bowen et al.'s Feasibility Framework and the Theoretical Framework of Acceptability, examining acceptability, demand, implementation, practicality, integration, and limited efficacy. The study will recruit 15 adults with SCI and up to 10 clinicians. Ten patient participants will be recruited from the outpatient FES cycling program and five from inpatient SCI rehabilitation. Up to 10 clinicians who integrate TSS into participant care will also be recruited. Outpatient participants will receive TSS during their regularly scheduled FES cycling sessions for four weeks. TSS will be delivered during routine 30-45-minute cycling sessions one to two times per week, targeting the cervical spine for upper-extremity cycling and lower thoracic/lumbar spine for lower-extremity cycling. Inpatient participants will receive TSS using Stim2Go during routine physiotherapy and occupational therapy for a minimum of four weeks, with a target of at least three TSS-assisted sessions per week. TSS will be embedded within usual rehabilitation activities, including transfer training, pre-gait and mobility training, activity-based therapy, and upper-extremity task-specific training. Primary feasibility outcomes will include recruitment, attrition, intervention adherence, adverse events, and patient and clinician experiences. Following the implementation period, patient participants will complete an acceptability survey and semi-structured interview. Clinicians will complete an acceptability survey and participate in a focus group exploring feasibility, acceptability, barriers, facilitators, and lessons learned from integrating TSS into practice. Exploratory clinical outcomes will also be examined. For outpatient participants, FES cycling outcomes from the four weeks before TSS will be compared descriptively with the four-week TSS period, including session time, distance, asymmetry, time without motor support, energy, power, crank velocity, and stimulation parameters. For inpatient participants, baseline and post-intervention outcomes will assess standing, walking, balance, mobility, endurance, upper- and lower-extremity strength, upper-extremity function when relevant, and independence in daily activities. Quantitative feasibility, demographic, survey, cycling, and clinical data will be summarized descriptively and visually. Individual changes in inpatient clinical outcomes will be interpreted using minimal detectable change values where available. Qualitative interview and focus group data will undergo codebook thematic analysis informed by interpretive description to identify implementation experiences, barriers, facilitators, and recommendations. This study will provide real-world evidence on whether and how TSS can be safely and feasibly incorporated into existing SCI rehabilitation services. Evaluating two devices across inpatient and outpatient contexts will identify practical implementation supports and setting-specific considerations not captured in laboratory-based research. Findings will inform recommendations to support adoption and sustained use of TSS across SCI rehabilitation settings in Canada.
Interventions
Transcutaneous spinal stimulation (TSS) is a non-invasive neuromodulation intervention that delivers electrical stimulation to spinal nerve roots through surface electrodes placed over the spinal cord. TSS will be delivered concurrently with participants' existing rehabilitation activities to modulate spinal neural circuitry and support motor activation during functional training. Stimulation will use a biphasic waveform with a 1000 μs pulse duration, frequency of 30-35 Hz, and amplitude up to 100 mA, individualized based on participant response and tolerance. Depending on the rehabilitation program and therapeutic goals, stimulation will be delivered using either the Xcite system with TSS functionality during outpatient FES cycling or the Stim2Go device during inpatient physiotherapy and occupational therapy.
OTHERInpatient SCI Physiotherapy
Inpatient spinal cord injury physiotherapy consists of individualized rehabilitation delivered as part of routine clinical care. Physiotherapy focuses on improving mobility, strength, balance, functional independence, and upper- and lower-extremity function according to each participant's rehabilitation goals and abilities. Interventions may include activity-based therapy, bed mobility and transfer training, sitting and standing balance, strengthening, pre-gait training, walking and mobility training, and other clinically appropriate therapeutic activities. Participants typically receive approximately five physiotherapy sessions per week, with sessions lasting approximately 45-90 minutes. Treatment selection, intensity, and progression are individualized by the treating physiotherapist based on the participant's clinical presentation, tolerance, and rehabilitation goals.
OTHERInpatient SCI Occupational Therapy
Inpatient spinal cord injury occupational therapy consists of individualized rehabilitation delivered as part of routine clinical care. Occupational therapy focuses on improving independence and participation in daily activities based on each participant's functional abilities and rehabilitation goals. Interventions may include upper-extremity strengthening and task-specific training, fine motor and hand function activities, activities of daily living such as dressing, grooming, and feeding, transfer and mobility-related activities, equipment assessment and training, and other clinically appropriate therapeutic activities. Participants typically receive approximately five occupational therapy sessions per week, with sessions lasting approximately 45-90 minutes. Treatment selection, intensity, and progression are individualized by the treating occupational therapist based on the participant's clinical presentation, tolerance, and rehabilitation goals.
OTHERFES Cycling
Functional electrical stimulation (FES) cycling consists of upper- or lower-extremity cycling using an RTI 300 cycle ergometer with electrical stimulation applied to selected muscles to facilitate active cycling. Upper-extremity FES cycling may stimulate muscles including the deltoids, biceps, triceps, wrist and finger flexors and extensors, and scapular stabilizers. Lower-extremity FES cycling may stimulate the gluteals, quadriceps, hamstrings, gastrocnemius, and tibialis anterior. Participants typically complete one to two FES cycling sessions per week, with sessions lasting approximately 60-90 minutes. Muscle selection and stimulation parameters are individualized according to each participant's functional abilities, therapeutic goals, and response to stimulation.
Sponsors
Janelle Unger
Praxis Spinal Cord Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This study uses a single-group, multi-intervention case series design to evaluate the feasibility of integrating transcutaneous spinal stimulation (TSS) into existing spinal cord injury rehabilitation. Participants will receive TSS within their existing clinical program: either outpatient functional electrical stimulation cycling or routine inpatient physiotherapy and occupational therapy. The two clinical contexts are not intended as comparative study arms; rather, each will be evaluated to understand the feasibility, safety, acceptability, and implementation of TSS within its respective rehabilitation setting.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of SCI * Enrolled in either the FES-Cycling program at Parkwood Institute for at least 6 weeks, or admitted to the In-Patient SCI Rehabilitation program at Parkwood Institute. * Be able to communicate and provide informed consent in English
Exclusion criteria
* Experiencing progressive worsening of symptoms related to their SCI * Have a secondary condition significantly impacting their ability to participate in active rehabilitation (e.g., uncontrolled orthostatic hypotension, high fracture risk, inability to follow directions, etc.). * Clinical team determines that the person has contraindications to using TSS (i.e., poor skin integrity on their back, implanted metal device along their spine, pacemaker, active fracture, pregnancy, cancer of the spine or adjacent to a stimulation area, uncontrolled epilepsy, uncontrolled autonomic dysreflexia). * Have an allergy to adhesives. * Have not had Botox to upper or lower extremities in the last three months. * Are not currently participating in another clinical trial with similar objectives.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Attrition Rate | Collected at the end of the intervention (Week 4). | The number of participants who are withdrawn from the study or drop out, expressed as a percentage of the total sample. |
| Adverse Events | Collected throughout the intervention period with final reporting at the end of the intervention (Week 4). | An Adverse Event reporting form will be used to track the number, type, and severity of adverse events. This data will be reported descriptively. |
| Feasibility Survey | Collected at the end of the intervention (Week 4). | All participants will complete a survey about the use of TSS during their therapy. This survey uses a 7-point Likert scale (strongly disagree to strongly agree) to score a total of 13 items, meaning the minimum score would be 13, indicating low feasibility, and the maximum score would be 91, indicating high feasibility. The findings will be reported descriptively. |
| Semi-Structured Interview | Collected at the end of the intervention (Week 4). | A semi-structured interview will ask participants for their perspectives on the intervention. The data will be reported qualitatively. |
| Recruitment Rate | During study enrolment | The number of participants that consent given the number of potential participants that are approached about the study, expressed as a percentage. |
| Intervention Adherence | Collected at the end of the intervention (Week 4). | The number of intervention sessions attended by participants compared to the anticipated number of sessions, expressed as a percentage. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Grip Strength | Collected at baseline and at the end of the intervention (Week 4). | For participants in inpatient rehabilitation, measured in kilograms. |
| Graded Redefined Assessment of Strength, Sensibility, and Prehension | Collected at baseline and at the end of the intervention (Week 4) as appropriate. | For participants in inpatient rehabilitation with upper extremity function identified as a goal. Standardized scale with 3 components and 20 items scored bilaterally. Minimum score of 0, indicating the lowest level of function, and a maximum score of 94, indicating the highest level of function. |
| Spinal Cord Independence Measure | Collected at baseline and at the end of the intervention (Week 4). | For participants in inpatient rehabilitation. Standardized scale with 4 components and 19 items. Minimum score of 0, indicating the lowest level of independence, and a maximum score of 100, indicating the highest level of independence. |
| Session Time | Collected throughout the intervention period with final reporting at the end of the intervention (Week 4). | Time spent in each session, along with time using TSS. Measured in minutes. |
| Distance Travelled | Collected throughout the intervention period with final reporting at the end of the intervention (Week 4). | For participants using the FES bike, measured in meters. |
| Asymmetry Output | Collected throughout the intervention period with final reporting at the end of the intervention (Week 4). | For participants using the FES bike, measured as percentage of time using the right and left legs. |
| Time Off Motor Support | Collected throughout the intervention period with final reporting at the end of the intervention (Week 4). | For participants using the FES bike, measured as percentage of time spent in active compared to passive cycling. |
| Energy | Collected throughout the intervention period with final reporting at the end of the intervention (Week 4). | For participants using the FES bike, measured as kilocalories per hour. |
| Power | Collected throughout the intervention period with final reporting at the end of the intervention (Week 4). | For participants using the FES bike, measured as average Watts over each session. |
| Velocity | Collected throughout the intervention period with final reporting at the end of the intervention (Week 4). | For participants using the FES bike, measured as average revolutions per minute (RPM) over each session. |
| Berg Balance Scale | Collected at baseline and at the end of the intervention (Week 4) as appropriate. | For participants in inpatient rehabilitation in SWAT stages 1-4. Standardized scale with 14 items scored from 0 to 4, with a minimum score of 0, indicating the lowest level of function, and a maximum score of 52, indicating the highest functional level. |
| Standing and Walking Assessment Tool (SWAT) | Collected at baseline and at the end of the intervention (Week 4). | For participants in inpatient rehabilitation. Standardized functional scale. Lowest functional stage of 0 (inability to stand) and highest functional stage of 4 (unimpaired community walking). |
| Modified Timed-Up-and-Go | Collected at baseline and at the end of the intervention (Week 4) as appropriate. | For participants in inpatient rehabilitation in SWAT stages 2-4. Measured in time taken to complete (seconds). |
| 10 Meter Walk Test | Collected at baseline and at the end of the intervention (Week 4) as appropriate. | For participants in inpatient rehabilitation in SWAT stages 2-4. Measured in time taken to complete which is converted to walking speed (meters per second). |
| Six Minute Walk Test | Collected at baseline and at the end of the intervention (Week 4) as appropriate. | For participants in inpatient rehabilitation in SWAT stages 3-4. Measured in total distance walked (meters). |
| Activities-specific Balance Confidence Scale | Collected at baseline and at the end of the intervention (Week 4) as appropriate. | For participants in inpatient rehabilitation in SWAT stages 2-4. Standardized scale with 16 items scored from 0 to 100 and then averaged, with a minimum score of 0, indicating the lowest level of confidence, and a maximum score of 100, indicating the highest confidence level. |
| Manual Muscle Testing | Collected at baseline and at the end of the intervention (Week 4). | For participants in inpatient rehabilitation. Standardized scale with 16 muscles scored from 0 (no muscle activation) to 5 (full strength against resistance) bilaterally. Total scores for the upper and lower extremity summed. |
Countries
Canada
Contacts
CONTACTJanelle Unger, PhD
Outcome results
None listed