Spinal Cord Injuries
Conditions
Keywords
Transcutaneous Spinal Cord Stimulation (TSCS)
Brief summary
Aim 1: Determine the safety and feasibility of administration of TSCS to children in a clinical setting. Participants will be randomly assigned to experimental (TSCS) or control (sham stimulation) groups. Both groups will receive eight-weeks of individualized gait training. We will measure adverse events, including pain and skin irritation, to determine safety as the primary outcome. Hypothesis 1: Administration of TSCS to children in a clinical setting will be safe based on similar safety outcomes as sham TSCS. Hypothesis 2: TSCS is feasible based on compliance to session interventions and long-term adherence to the protocol. Additionally, we will collect data on effort during sessions of both participant and therapist. We anticipate that the participants will report less effort in the experimental condition, as compared to the control and therapists will report equal effort across conditions. Aim 2: Determine the neurophysiologic impact of TSCS within a single session. We hypothesize that participants will demonstrate increased volitional muscle activity and strength with TSCS as compared to sham stimulation. This will be assessed by surface EMG and hand-held dynamometry of the dominant-side quadriceps muscle during maximum volitional contraction (MVC), across multiple time points. Changes in EMG activity will indicate change in central excitability in response to stimulation. Aim 3: Exploratory measurement of TSCS and gait training on walking function. We hypothesize that concurrent TSCS and gait training will augment walking function in children with iSCI, as compared to gait training with sham stimulation. In addition to outcomes defined above, participants will be assessed with clinically relevant outcome measures, to include the Timed Up and Go, 10-Meter Walk Test, Walking Index for Spinal Cord Injury II, and 6-Minute Walk Test. Data collected as part of this aim will elucidate trends in responder qualities and timeline of changes to inform future studies.
Interventions
OTHERGait training with/without TSCS
To assess the safety and impact of paired stimulation and training on gait in children with iSCI, participants will participate in 24 total sessions. Two sessions will involve assessment only and 22 sessions will include two hours of therapy. Sessions will occur at least three times per week, but may be scheduled as many as five times per week. In each session, participants will receive 60 minutes of treadmill training followed by strengthening, segmental task practice, and gait-based interventions. Participants will receive stimulation based on their group assignment (TSCS or sham).
Sponsors
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Years to 16 Years
Healthy volunteers
No
Inclusion criteria
* Age 3-16 * ≥ 6 months post injury * Non-progressive SCI * American Spinal Injury Association Impairment Scale (AIS) Classification C or D AIS C is an incomplete classification where more than half of the key muscles below the neurological level have a muscle grade of 3 or less AIS D is an incomplete classification where more than half of the key muscles below the neurological level have a muscle grade of more than 3 * Neurologic level above T10 * Tolerates upright position for \>30 minutes * Able to advance one lower extremity (LE) when in standing, bracing and assistive device allowed * Medically stable (no hospitalizations in last 3 mos.) * Able to comply with The International Standards for neurological and functional Classification of Spinal Cord Injury (ISNCSCI) exam
Exclusion criteria
* Progressive Spinal Cord Injury or Disease (SCI/D) (Multiple Sclerosis, Acute Disseminated Encephalomyelitis, etc.) * Active wounds * Range of motion limits impacting gait training * Cardiac pacemaker/defibrillator * Active cancer diagnosis * Absent LE reflexes * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Timed Up and Go (TUG) | session 1, 6, 12, 18, and 24 (5-8 weeks total) | Measures walking function, balance, and mobility. |
| 10-Meter Walk Test (10MWT) | session 1, 6, 12, 18, and 24 (5-8 weeks total) | Measures walking speed. |
| Walking Index for Spinal Cord Injury II (WISCI II) | session 1, 6, 12, 18, and 24 (5-8 weeks total) | Measures walking quality, including need for assistive device and physical assistance. |
| 6-Minute Walk Test (6MWT) | session 1, 6, 12, 18, and 24 (5-8 weeks total) | Measures walking endurance |
Countries
United States
Contacts
CONTACTShannon M Inches
PRINCIPAL_INVESTIGATORRebecca Martin, OTR/L, OTD, CPAM
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Outcome results
None listed