Clinical trial NCT05091463: Non-invasive Spinal Stimulation as an Adjuvant Therapy for Trunk Control After Pediatric SCI
Official title: Non-invasive Spinal Stimulation as an Adjuvant Therapy for Trunk Control After Pediatric Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Spinal Cord Injuries
Keywords: Pediatric-onset
Transcutaneous spinal stimulation
Trunk deficit
Lead sponsor: University of Louisville
Sponsor class: OTHER
Collaborators: name: The Craig H. Neilsen Foundation
First posted: 2021-10-25
Enrollment: 12
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Segmental Assessment of Trunk Control
timeFrame: Change from baseline (Pre-Intervention), after 20 sessions, after 40 sessions, after 60 sessions and after 3 months post 60 sessions(each session is 1.5 hours)
measure: Modified Function Reach (MFR)
timeFrame: Change from baseline (Pre-Intervention), after 20 sessions, after 40 sessions, after 60 sessions and after 3 months post 60 sessions(each session is 1.5 hours)
Secondary outcomes:
measure: Center of Pressure (CoP) displacement
timeFrame: baseline (Pre-Intervention), After 60 intervention Sessions (each session is 1.5 hours) and 3 months after 60 sessions end
measure: Angular Excursions of the Trunk
timeFrame: baseline (Pre-Intervention), After 60 Intervention sessions (each session is 1.5 hours) and 3 months after 60 sessions end
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Kentucky Spinal Cord Injury Res Center, University of Louisville
state: Kentucky
Study officials:
affiliation: University of Louisville
name: Andrea L Behrman, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: