Transcutaneous Stimulation for Neurological Populations
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-70
SponsorUniversity of Washington
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
Gait Training
Other interventionTraining that targets rehabilitation of walking function
Transcutaneous Spinal Stimulation
DeviceNon-invasive electrical stimulation of the spinal cord over the skin combined with gait training
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Intensive Training OnlyActive comparator 1 intervention
Group B: Intensive Training Combined with Spinal StimulationActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
Change from baseline - Six Minute Walk Test
Measure of walking ability. The distance is reported in meters.
Time frame
Measurements at baseline and repeated measurements once every two weeks throughout the study, an average of 10 months.2
Change from baseline - Ten Meter Walk Test
The measure of walking ability at fast and self-selected speeds. The walking speed is reported as meters per second.
Time frame
Measurements at baseline and repeated measurements once every two weeks throughout the study, an average of 10 months.Secondary outcomes
1
Change from baseline - Kinetic and kinematic gait analysis using three dimensional camera system
Measurement of leg function and walking ability. Joint angle is reported in angle degrees, and velocity is reported in meters per second. Kinematic analysis will able to used to measure gait coordination and spatiotemporal outcomes, such as step length and step time.
Time frame
Measurements at baseline and repeated measurements once every two months throughout the study, an average of 10 months.2
Change from baseline - Electromyography recording of lower extremity muscles
Measurement of muscle and nerve functions. The muscle activities are reported in micro-volts.
Time frame
Measurements at baseline and repeated measurements once every two months throughout the study, an average of 10 months.3
Change from baseline - Gait Outcomes Assessment List
The patient-reported outcome measure for ambulatory children with cerebral palsy. The Gait Outcomes Assessment List comprises 48 items distributed across 7 subscales and spans all domains of the International Classification of Functioning, Disability, and Health. The score range is between 0 and 100. The higher scores mean a better outcome.
Time frame
Measurements at baseline and repeated measurements once every two months throughout the study, an average of 10 months.4
Change from baseline - Timed Up and Go
Measurement of mobility and fall risk. The time to complete the test is recorded in seconds.
Time frame
Measurements at baseline and repeated measurements once every two months throughout the study, an average of 10 months.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Washington
Lead sponsor
Seattle Children's Hospital
Collaborator
Source ClinicalTrials.gov