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Spinal Stimulation and Mobility Devices

Primary Purpose

Cerebral Palsy, Stroke, Premature Birth

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mobility Device
Spinal Stimulation
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Cerebral Palsy focused on measuring Pediatric, Mobility Aids, Assistive Technology, Spinal Stimulation

Eligibility Criteria

4 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • have a neurologic condition
  • are 4-70 years of age
  • have stable medical condition
  • can perform simple cued motor tasks and who can follow 2-3 step commands
  • who are volunteering to be involved in this study
  • can provide feedback on comfort and experience during lab visits

Exclusion Criteria:

  • 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.
  • have cardiovascular or musculoskeletal disease or injury that would prevent full participation in physical therapy intervention
  • have a history of uncontrolled seizures
  • have unhealed fracture or other musculoskeletal impairment that might interfere with lower extremity rehabilitation or testing activities
  • are dependent on ventilation support
  • have implanted stimulator (e.g. epidural stimulator, vagus nerve stimulator, pacemaker, cochlear implant, etc) or drug delivery device (e.g. baclofen pump)
  • 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
  • have established osteoporosis and taking medication for osteoporosis treatment.
  • have rheumatic diseases (rheumatoid arthritis, systemic lupus erythematosus, etc.)
  • have active cancer

Sites / Locations

  • University of WashingtonRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Neurologic Disorders

Arm Description

Evaluation of individual and combined effects of mobility devices and spinal stimulation for individuals with neurologic disorders.

Outcomes

Primary Outcome Measures

Muscle Coordination
Change in level of co-contraction between the plantarflexor and tibialis anterior muscles during the gait cycle monitored from electromyography recordings.

Secondary Outcome Measures

Modified Ashworth Scale
Change in summed score of spasticity from lower-extremity muscles. Lower values indicate less spasticity.
Plantarflexor Muscle Strength
Change in maximum voluntary contraction level of the plantarflexor muscles taken as the average of three trials where the participant exerts the maximum amount of force measured from a handheld dynamometer with verbal encouragement.

Full Information

First Posted
August 22, 2022
Last Updated
October 23, 2023
Sponsor
University of Washington
Collaborators
Seattle Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05520359
Brief Title
Spinal Stimulation and Mobility Devices
Official Title
Transcutaneous Stimulation and Mobility Device Use for Individuals With Neurologic Conditions
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 4, 2022 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
Seattle Children's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This research study will combine non-invasive spinal stimulation with mobility devices to examine the acute impact of the individual and combined effects of these innovative techniques on mobility in children with cerebral palsy.
Detailed Description
For people with neurological conditions, excessive and inappropriate muscle activity resulting from injured sensory pathways (e.g., spasticity or hypertonicity) contributes to inefficient movement, bone deformities, pain, and other comorbidities. Research with humans and animals have highlighted the critical importance of both motor and sensory pathways for motor learning after neurologic injury. However, the best techniques for engaging motor and sensory pathways in a way that brings high quality mobility are not well understood. With this study we will examinee how increased sensory feedback, through mobility device use and electrical spinal stimulation, impact movement mechanics in people with neurological conditions to inform long-term studies and eventual implementation into clinical practice. Mobility devices offer a promising approach to improve mobility rehabilitation through engagement of sensory and motor pathways. These devices can either assist in movement by providing support to perform an activity or they can be used to provide resistance to build strength. Mechanistically how these devices impact movement mechanics is still not well understood. Electrical spinal stimulation with intensive, repetitive training has demonstrated exciting potential to improve limb function after neurologic injury. Spinal stimulation has shown to improve motor function with long-term training. Stimulation is hypothesized to improve motor pathways through boosting sensory input. However, the neuromechanical effects of stimulation as a result of increased sensory feedback over an acute time frame has not been explored in efforts to test this hypothesis. This study aims to evaluate the acute effects of increased afferent feedback in individuals with neurological conditions via mobility devices and spinal stimulation. Understanding how these approaches affect the quantity and quality of movement in the short term is a first step before determining potential treatment outcomes. In this research, we will quantify the neuromechanics of movement with and without these approaches for individuals with neurologic disorders.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Stroke, Premature Birth, Hypoxic-Ischemic Encephalopathy, Periventricular Leukomalacia
Keywords
Pediatric, Mobility Aids, Assistive Technology, Spinal Stimulation

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Randomized order of visits with individual and combined effects of mobility devices and spinal stimulation.
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Neurologic Disorders
Arm Type
Experimental
Arm Description
Evaluation of individual and combined effects of mobility devices and spinal stimulation for individuals with neurologic disorders.
Intervention Type
Device
Intervention Name(s)
Mobility Device
Other Intervention Name(s)
Biomotum SPARK, Trexo, Portable Mobility Aid for Children (PUMA, ENLITEN)
Intervention Description
Use of mobility device during session.
Intervention Type
Device
Intervention Name(s)
Spinal Stimulation
Other Intervention Name(s)
SpineX
Intervention Description
A stimulator will be used non-invasively stimulate the spine at the neck and/or lower back (cervical and/or lum
Primary Outcome Measure Information:
Title
Muscle Coordination
Description
Change in level of co-contraction between the plantarflexor and tibialis anterior muscles during the gait cycle monitored from electromyography recordings.
Time Frame
Comparing first and last minute of walking on treadmill at each experimental session.
Secondary Outcome Measure Information:
Title
Modified Ashworth Scale
Description
Change in summed score of spasticity from lower-extremity muscles. Lower values indicate less spasticity.
Time Frame
Physical exam conducted at the beginning and end of each experimental session.
Title
Plantarflexor Muscle Strength
Description
Change in maximum voluntary contraction level of the plantarflexor muscles taken as the average of three trials where the participant exerts the maximum amount of force measured from a handheld dynamometer with verbal encouragement.
Time Frame
Physical exam conducted at the beginning and end of experimental session.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: have a neurologic condition are 4-70 years of age have stable medical condition can perform simple cued motor tasks and who can follow 2-3 step commands who are volunteering to be involved in this study can provide feedback on comfort and experience during lab visits Exclusion Criteria: 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. have cardiovascular or musculoskeletal disease or injury that would prevent full participation in physical therapy intervention have a history of uncontrolled seizures have unhealed fracture or other musculoskeletal impairment that might interfere with lower extremity rehabilitation or testing activities are dependent on ventilation support have implanted stimulator (e.g. epidural stimulator, vagus nerve stimulator, pacemaker, cochlear implant, etc) or drug delivery device (e.g. baclofen pump) 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 have established osteoporosis and taking medication for osteoporosis treatment. have rheumatic diseases (rheumatoid arthritis, systemic lupus erythematosus, etc.) have active cancer
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Katherine Steele, PHD
Phone
206-685-2390
Email
kmsteele@uw.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Charlotte Caskey
Phone
864-207-1155
Email
cdcaskey@uw.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katherine Steele, PHD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katie Landwehr, MS
Phone
937-231-1205
Email
klandweh@uw.edu
First Name & Middle Initial & Last Name & Degree
Siddhi Shrivastav, PhD
Phone
973-444-1940
Email
siddhis@uw.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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