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 range3 Years – 12 Years

SexALL

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

What they're measuring

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)

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)

Trial details

NCT IDNCT05091463

SponsorUniversity of Louisville

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-07-30

View on ClinicalTrials.gov More Spinal Cord Injuries trials

Plain-language summary

Who can participate

Age range3 Years – 12 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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)

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)