SCIMS Site Specific Project: Activating Spinal Circuits to Improve Walking, Balance, Strength, and Reduce Spasticity

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

For many people with spinal cord injury (SCI), the goal of walking is a high priority. There are many approaches available to restore walking function after SCI; however, these approaches often involve extensive rehabilitation training and access to facilities, qualified staff, and advanced technology that make practicing walking at home difficult. For this reason, developing training approaches that could be easily performed in the home would be of great value. In addition, non-invasive spinal stimulation has the potential to increase the effectiveness of communication between the brain and spinal cord. Combining motor skill training (MST) with transcutaneous spinal stimulation (TSS) may further enhance the restoration of function in persons with SCI. Therefore, the purpose of this study is to determine if moderate-intensity, MST can improve walking-related outcomes among persons with SCI and to determine if the addition of non-invasive TSS will result in greater improvements in function compared to training alone.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Be 18-70 years of age

• Have a spinal cord injury (neurological level C3-T12) that occurred ≥3 months (sub-acute to chronic) prior to enrollment

• Have ISNCSCI severity classification C or D

• Able to stand for at least 5 minutes (with or without the aid of an assistive device)

• Able to move each leg independently for at least 3 steps (with or without the aid of an assistive device)

• Able to rise from sit to stand with moderate assistance from one person

• Use of prescription medication(s) for control of spasticity if the dosage has not changed in the last 2 weeks and you notify the study staff if your medication(s) change during study participation

• Ability and willingness to consent and authorize use of personal health information

• Ability to follow multiple instructions and communicate pain or discomfort

Locations
United States
Georgia
Shepherd Center
RECRUITING
Atlanta
Contact Information
Primary
Charles J Creech, DPT
jacob.creech@shepherd.org
678-877-9572
Backup
Nicholas Evans, MHS, PhD
Nicholas.Evans@shepherd.org
404-350-7742
Time Frame
Start Date: 2022-03-01
Estimated Completion Date: 2026-03
Participants
Target number of participants: 28
Treatments
Experimental: MST + TSS
Individuals will participate in 6 training sessions of MST combined with TSS.
Sham_comparator: MST + ShamTSS
Individuals will participate in 6 training sessions of MST while receiving shamTSS.
Authors
Edelle C Field-Fote
Sponsors
Collaborators: National Institute on Disability, Independent Living, and Rehabilitation Research
Leads: Shepherd Center, Atlanta GA

This content was sourced from clinicaltrials.gov