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Non-invasive Spinal Stimulation for Spinal Cord Injury
N/A
Waitlist Available
Led By Andrea L Behrman, PT, PhD
Research Sponsored by University of Louisville
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (pre-intervention), after 60 intervention sessions (each session is 1.5 hours) and 3 months after 60 sessions end
Awards & highlights
Study Summary
This trial will 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.
Who is the study for?
This trial is for children aged 3-12 with chronic spinal cord injuries at T10 or above, who are not able to walk and have moderate to severe trunk control issues. They should be new to both activity-based locomotor training and transcutaneous spinal stimulation, and must have been out of in-patient rehab for over a year.Check my eligibility
What is being tested?
The study tests if combining locomotor training with non-invasive spinal stimulation can help improve sitting posture and trunk control in kids with long-term spinal cord injuries. It will involve 12 participants who haven't tried this method before.See study design
What are the potential side effects?
Potential side effects aren't specified here, but similar treatments may cause discomfort at the stimulation site, skin irritation, or muscle fatigue during or after treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been discharged from in-patient rehab.
Select...
I struggle with sitting up straight or reaching without losing my balance.
Select...
I have never had locomotor training or spinal stimulation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (pre-intervention), after 60 intervention sessions (each session is 1.5 hours) and 3 months after 60 sessions end
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (pre-intervention), after 60 intervention sessions (each session is 1.5 hours) and 3 months after 60 sessions end
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Modified Function Reach (MFR)
Segmental Assessment of Trunk Control
Secondary outcome measures
Angular Excursions of the Trunk
Center of Pressure (CoP) displacement
Trial Design
1Treatment groups
Experimental Treatment
Group I: Transcutaneous spinal stimulationExperimental Treatment1 Intervention
Participants with chronic SCI will receive 60 sessions of activity based-locomotor training (AB-LT) combined with transcutaneous stimulation (scTS).
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Who is running the clinical trial?
University of LouisvilleLead Sponsor
338 Previous Clinical Trials
75,972 Total Patients Enrolled
The Craig H. Neilsen FoundationOTHER
54 Previous Clinical Trials
2,883 Total Patients Enrolled
Andrea L Behrman, PT, PhDPrincipal InvestigatorUniversity of Louisville
2 Previous Clinical Trials
18 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a physical condition that limits my movement or an unhealed fracture.My spinal cord injury is due to Spina Bifida.I am currently taking oral baclofen and cannot or do not want to stop under a doctor's advice.I have been discharged from in-patient rehab.I struggle with sitting up straight or reaching without losing my balance.I have had an upper body nerve injury for over a year.I have had surgery for scoliosis.I have never had locomotor training or spinal stimulation.I am not willing to stop using my back brace during the study.I have not used Botox in the last 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: Transcutaneous spinal stimulation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Will individuals aged 65 and above be allowed to partake in this experiment?
"The age range for this research project is between 3 and 12 years old."
Answered by AI
Has recruitment for this experiment commenced?
"Contrary to expectations, clinicaltrials.gov reveals that this study is no longer in need of participants; the original posting was on August 31st 2021 and it had been updated lastly on October 22nd 2021. Nonetheless, there are currently 352 other trials which require patient enrollment."
Answered by AI
Is there an opportunity for me to partake in this medical experiment?
"The eligibility criteria for this trial stipulates that participants must have a spinal cord injury and be between the ages of 3 to 12. The research team is looking for a cohort size of 12 patients in total."
Answered by AI
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