Non-invasive Spinal Stimulation as an Adjuvant Therapy for Trunk Control After Pediatric SCI
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About
The overall purpose of this study is to test the efficacy of multi-modal training combining activity-based locomotor training and transcutaneous spinal stimulation (ABLT+scTS) to improve sitting posture and trunk control in children with a chronic spinal cord injury.
The investigators will recruit 12 participants, ages 3-12 with chronic, acquired SCI, T10 and above and non-ambulatory. The participants in this study will be novices to scTS and AB-LT.
Full description
This is a within subjects, repeated measures design study. Participants with chronic, acquired SCI (T10 and above and non-ambulatory), ages 3-12 years will serve as their own control and will participate in the studies for all three aims. The participants in this study will be novices to scTS and AB-LT. Medical history and demographics will be collected according to NINDS-Common Data Elements guidelines for pediatric SCI and recommended, standardized outcomes used.
The participants will participate in 60 sessions, 5 days/week for 90 minutes/session. The participants will be assessed at the following time points: Baseline (prior to intervention), after 20 sessions, after 40 sessions and after 60 sessions.
If possible, there will be follow-up assessments occur at 3 months post-60 sessions.
Aim 1: To determine the effects of 60 AB-LT + scTS therapy sessions on sitting posture and trunk control.
Participants will be tested over a total of 4 session (2 pre- and 2 post-60 session intervention). Sessions 1 and 2 will include testing for clinical (Segmental Assessment of Trunk Control (SATCo) and Modified Functional Reach (MFR)) and biomechanical outcomes (Sitting with best posture and MFR), respectively. The two sessions will be conducted within one week.
Aim 2: Determine a) the rate of change in sitting posture and trunk control across, 20, 40, and 60 sessions of AB-LT + scTS, b) the durability of training effects at 3-months follow-up, and c) responsiveness of clinical outcome measures (SATCo and MFR) of trunk control.
Aim 3: To determine residual activation of trunk muscle below the level of the lesion, functional neurophysiological assessment (FNPA) and trunk perturbations will be assess pre- and post-intervention.
The investigators will attain parent/guardian informed consent and participant assent for children > 7 years. Twelve total participants, ages 3-12 years will be recruited and enrolled for all three aims. Participants will be enrolled for 60 sessions (3 months) for the intervention and will be re-tested 3 months post-training.
Enrollment
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Inclusion criteria
- Chronic (> 1 year since injury), Acquired Upper motor Neuron injury (T10 and above)
- Discharged from in-patient rehabilitation
- Moderate to severe trunk control deficit as assessed by the Segmental Assessment of Trunk Control (SATCo, score <16/20) OR unable to fully sit upright while lifting their arms or reaching outside of their base of support while maintaining posture
- Novice to activity-based locomotor training and transcutaneous spinal stimulation
Exclusion criteria
- Botox use within the past 3 months
- Current oral baclofen use and unwillingness or unable to wean under medical guidance
- Baclofen pump use
- Musculoskeletal impairment limiting range of motion, unhealed fracture, or other medical complication limiting participation
- Prior surgery for scoliosis
- Unwillingness to wean from the use of thoraco-lumbosacral orthosis (TLSO) during study
- Spina Bifida as etiology of spinal cord injury
Trial design
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Interventional model
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12 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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