Non-invasive Spinal Stimulation as an Adjuvant Therapy for Trunk Control After Pediatric SCI (NCT05091463) | Clinical Trial Compass
By InvitationNot Applicable
Non-invasive Spinal Stimulation as an Adjuvant Therapy for Trunk Control After Pediatric SCI
United States12 participantsStarted 2021-08-31
Plain-language 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.
Who can participate
Age range
3 Years – 12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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)
2
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)