RECRUITING

Transcutaneous Stimulation for Neurological Populations

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Conditions

Neurological DisorderCerebral PalsySpinal Electrical StimulationTreadmill Training

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2021-01-01
Study Completion:2027-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04467437

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:4 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * have a neurologic condition
  2. * can walk 20 yards, with or without an assistive device
  3. * have stable medical condition
  4. * are capable of performing simple cued motor tasks and who can follow 2-3 step commands
  5. * have ability to attend up to 5 sessions per week physical therapy sessions and testing activities
  6. * 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.
  7. * who are volunteering to be involved in this study
  8. * can read and speak English
  1. * have significant medical disease; including uncontrolled systemic hypertension with values above 170/100 mmHg; cardiac or pulmonary disease; uncorrected coagulation abnormalities or need for therapeutic anticoagulation.
  2. * have cardiovascular or musculoskeletal disease or injury that would prevent full participation in physical therapy intervention
  3. * have a history of uncontrolled seizures
  4. * have unhealed fracture or other musculoskeletal impairment that might interfere with lower extremity rehabilitation or testing activities
  5. * are dependent on ventilation support
  6. * have implanted stimulator (e.g. epidural stimulator, vagus nerve stimulator, pacemaker, cochlear implant, etc) or drug delivery device (e.g. baclofen pump)
  7. * have history of orthopedic surgery in lower extremities or neurosurgery that may be a confounding factor for interpretation of the results (such as tendon transfer, tendon or muscle lengthening for spasticity management, injection therapies to lower extremity muscles, etc.) in last 12 months
  8. * have established osteoporosis and taking medication for osteoporosis treatment.
  9. * have rheumatic diseases (rheumatoid arthritis, systemic lupus erythematosus, etc.)
  10. * have active cancer

Contacts and Locations

Study Contact

Siddhi R Shrivastav, BPTh, MS
CONTACT
973-444-1940
siddhis@uw.edu
Chet T Moritz, PhD
CONTACT
206-221-2842
ctmoritz@uw.edu

Principal Investigator

Katherine M Steele, PhD
PRINCIPAL_INVESTIGATOR
University of Washington

Study Locations (Sites)

University of Washington
Seattle, Washington, 98115
United States

Collaborators and Investigators

Sponsor: University of Washington

  • Katherine M Steele, PhD, PRINCIPAL_INVESTIGATOR, University of Washington

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-01-01
Study Completion Date2027-12

Study Record Updates

Study Start Date2021-01-01
Study Completion Date2027-12

Terms related to this study

Keywords Provided by Researchers

  • Spinal Electrical Stimulation
  • Treadmill Training

Additional Relevant MeSH Terms

  • Neurological Disorder
  • Cerebral Palsy