RecruitingNot ApplicableNCT04467437

Transcutaneous Stimulation for Neurological Populations

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


Sponsor

University of Washington

Enrollment

20 participants

Start Date

Jan 1, 2021

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 4 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Gait Training and a medical device called Transcutaneous Spinal Stimulation for people with cerebral palsy and neurological disorder. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERGait Training

Training that targets rehabilitation of walking function

DEVICETranscutaneous Spinal Stimulation

Non-invasive electrical stimulation of the spinal cord over the skin combined with gait training


Locations(1)

University of Washington

Seattle, Washington, United States

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NCT04467437


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