Transcutaneous Spinal Stimulation With Intensive Gait Training for Individuals With Neurologic Conditions

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

The purpose of the study is to evaluate whether non-invasive stimulation over the spinal cord at the neck and/or lower back can improve walking function for people with neurologic conditions. Spinal stimulation has been used extensively for individuals with spinal cord injury, and has demonstrated improvements in function. This study will extend this work to other neurologic conditions, such as cerebral palsy and stroke, that also demonstrate similar impairments as spinal cord injury. The primary aims of this study are to: Aim 1: Evaluate impact of spinal stimulation on spasticity and locomotor function. Aim 2: Investigate participant perceptions of spinal stimulation. The investigators will be using a cross-over design study to compare intensive training only to intensive training combined with spinal stimulation. After an initial baseline period of up to 4 weeks (Phase I). Participants will have their first intervention phase of the study (Phase II). This will involve either intensive training only (Condition A) or intensive training combined with spinal stimulation (Condition B). This will be followed by a washout period with no intervention (Phase III) and then the second intervention phase (Phase IV). The second intervention phase will involve either Condition A or Condition B, whichever the participants did not received during Phase II. Phases II-IV will each last up to 8 weeks. After the intervention period is complete, the participant will be asked to come for follow-up visits up to 3 months after the intervention phases are completed (Phase V).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 4
Maximum Age: 70
Healthy Volunteers: f
View:

• have a neurologic condition

• can walk 20 yards, with or without an assistive device

• have stable medical condition

• are capable of performing simple cued motor tasks and who can follow 2-3 step commands

• have ability to attend up to 5 sessions per week physical therapy sessions and testing activities

• have adequate social support to be able to participate in training and assessment sessions, up to 5 sessions per week, for the duration of up to 11 months within the study period.

• who are volunteering to be involved in this study

• can read and speak English

Locations
United States
Washington
University of Washington
RECRUITING
Seattle
Contact Information
Primary
Siddhi R Shrivastav, BPTh, MS
siddhis@uw.edu
973-444-1940
Backup
Chet T Moritz, PhD
ctmoritz@uw.edu
206-221-2842
Time Frame
Start Date: 2021-01-01
Estimated Completion Date: 2027-12
Participants
Target number of participants: 20
Treatments
Active_comparator: Intensive Training Only
Physical and gait training that targets rehabilitation of walking function.
Active_comparator: Intensive Training Combined with Spinal Stimulation
Transcutaneous spinal stimulation combined with physical and gait training that targets rehabilitation of walking function.
Related Therapeutic Areas
Sponsors
Collaborators: Seattle Children's Hospital
Leads: University of Washington

This content was sourced from clinicaltrials.gov