Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-25 @ 2:30 AM
NCT ID:
NCT03237234
Brief 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 brain stimulation has the potential to increase the effectiveness of communication between the brain and spinal cord. Combining motor skill training with brain stimulation may further enhance the restoration of function in persons with SCI. Based on these findings, the primary aim of this proof-of-concept study is to inform future intervention development. To meet this aim, we will determine if moderate-intensity, motor skill training can improve walking-related outcomes among persons with SCI and to determine if the addition of non-invasive brain stimulation will result in greater improvements in function compared to training alone.
Detailed Description:
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 access to intensive training programs, 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, research suggests that enhancing brain excitability might have benefits for improving the communication between the brain and spinal cord. Transcranial direct current stimulation (tDCS) is a type of non-invasive brain stimulation that has been shown to directly increase brain excitability, which may make it easier for the brain and nervous system to respond to training. Combining motor skill exercises with brain stimulation may enhance the restoration of walking function in persons with SCI. Based on these findings, the primary aim of this proof-of-concept study is to inform future intervention development. To meet this aim, we will determine if moderate-intensity, motor skill training can improve walking-related outcomes among persons with SCI and to determine if the addition of non-invasive brain stimulation will result in greater improvements in function compared to training alone.
Participants in the proposed study will complete one baseline testing session, 3 motor training sessions, and one follow-up session over 5 consecutive days. During the first and fifth sessions, participants will complete assessments only, which will take approximately 2-3 hours each day. During the second, third, and fourth sessions, participants will perform a series of 6 standing motor skill exercises designed to challenge balance, lower extremity coordination, agility, and speed. Participants will be randomized to either a motor training only group or a motor training + tDCS group. The motor training + tDCS group will receive brain stimulation during the motor skill training, while the motor training only group will receive sensory level brain stimulation only. Each participant will complete the 6 motor skill exercise circuit 4 times. Motor training exercise sessions will last approximately 25-30 minutes and will be preceded and followed by assessments of walking function, spasticity, and ankle strength in order to determine changes in these measures over time.
Study:
NCT03237234
Study Brief:
Protocol Section:
NCT03237234