An interventional study of Spinal Stimulation and Treadmill Walking in Cerebral Palsy, sponsored by University of Washington. Recruiting at 1 site in United States. Open to participants aged 4 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by University of Washington · Not applicable, Interventional, and Basic science
Among 10 studies in Cerebral Palsy by University of Washington — 4 open to participants now, 4 under way, none of them phase 3. Cerebral Palsy · University of Washington.
Among the 10 studies in Cerebral Palsy by University of Washington, this one is the only one that started in 2026, is one of 8 with no phase, and was the 9th registered.
1,936 studies on the registry are indexed under Cerebral Palsy; 458 are open to participants now.
Browse Cerebral Palsy studies →4 of the 10 studies in Cerebral Palsy by University of Washington are open now, in 1 country. Recruiting first, the newest first:
University of Washington · Sites in United States
University of Washington · Sites in United States
University of Washington · Sites in United States
By country, each count listing its studies:
Of the 270 Cerebral Palsy studies recruiting now, 27 (10%) set no upper age limit and 235 (87%) stop at 75 or younger; 255 take children under 18; 51 take healthy volunteers.
This study: 4 Years to 65 Years · all sexes · no healthy volunteers.
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10 studies; the count open now beside each. This study's row is marked.
First in 2013; this study’s year is marked. 1 started in 2026.
This study's planned enrollment of 20 is below the median of 34 across 1,431 interventional studies indexed under Cerebral Palsy.
Median enrollment 22 across the 8 interventional studies, 390 across the 2 observational. Of the 6 that completed or were terminated, 5 (83%) have results posted.
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University of Washington is the lead sponsor of 1,433 studies on the registry; 225 are open to participants now.
Of its 158 completed or terminated interventional studies of FDA-regulated products, 136 (86%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 10 studies in Cerebral Palsy by University of Washington, from their registry updates:
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This research study will examine the acute effects of non-invasive spinal stimulation on spasticity and walking in individuals with cerebral palsy. The hypothesis is that walking with spinal stimulation will lead to greater reductions in spasticity than walking without spinal stimulation. Additionally, it is hypothesized that the average step length and Gait Deviation Index will be higher while walking with spinal stimulation compared to walking without spinal stimulation.
Children with cerebral palsy (CP) have altered neuromuscular control that impacts gait and participation in daily activities. This research will characterize the acute effects of transcutaneous spinal stimulation (tSCS) on spasticity and gait for individuals with CP using a combined approach of quantitative biomechanical assessment and clinician assessment. Previous research has shown decreases in spasticity after walking with tSCS, but it is unclear whether these changes are due to physical activity or neuromodulation. This research will provide a foundation to characterize changes in spasticity after an acute session of tSCS for individuals with CP.
This research will use the SpineX Spinal Cord Innovation in Pediatrics (SCiP) system. The SCIP system allows for tSCS intensity (mA) at two electrodes to be independently adjusted in 1 mA increments. Other stimulation parameters such as pulse frequency (30 Hz), overlap frequency (10 kHz), pulse width (1 ms), and waveform (biphasic) are constant on the SCiP device. To target sensorimotor function of lower-extremity muscle groups within the spinal cord, the two electrodes are positioned over the spinous process at T11 and L1 with grounding electrodes placed on the pelvis. The tSCS intensity will be set to each individual's maximum tolerable stimulation intensity.
This study will recruit 20 individuals with CP to attend two in-lab visits. One visit will include treadmill walking with tSCS and the other will include treadmill walking without tSCS. The visit order will be pseudo-randomized and balanced across participants. Participants will be consented at the initial visit and will also conduct 3 trials of the 10-Meter Walk Test to evaluate self-selected walking speed. The average speed from these trials will be used to set treadmill speed. At the beginning of each visit, participants will complete a physical exam to characterize range of motion and spasticity via the Modified Tardieu Scale. Participants will complete a 5-minute treadmill familiarization at their self-selected speed to ensure it is comfortable. The tSCS intensity will gradually increase during treadmill familiarization until participants report discomfort. The tSCS intensity will be set at 1 mA below the level of discomfort if the visit calls for tSCS. During the treadmill walking, participants will walk at their self-selected walking speed for 10 - 20 minutes with either (1) no stimulation or (2) tSCS at their maximum tolerable stimulation intensity.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Individuals who:
Exclusion Criteria:
Individuals who:
Participants randomized into this arm will complete two visits. The first visit will use spinal stimulation while walking on a treadmill, and the second visit will be treadmill walking without stimulation.
Device: Spinal Stimulation · Other: Treadmill Walking
Participants randomized into this arm will complete two visits. The first visit will involve walking on a treadmill without stimulation, while the second visit will be treadmill walking with stimulation.
Device: Spinal Stimulation · Other: Treadmill Walking
A stimulator will be used non-invasively stimulate the spine at the neck and/or lower back (cervical and/or lumbar).
Also known as: SpineX, xStep
Participant will walk on a treadmill.
Modified Tardieu Scale of Spasticity
Change in quality of muscle reaction of the gastrocnemius assessed by the score on the Tardieu assessment. Lower score indicates less spasticity.
Time frame: End of treadmill walking during visit, anticipated average 20 minutes, relative to baseline at start of visit.
Step Length
From quantitative gait analysis step length is quantified as the average during the final minute of walking using gait analysis and markers on the foot.
Time frame: End of treadmill walking during visit, anticipated average 20 minutes, relative to baseline at start of visit.
Gait Deviation Index (GDI)
A multivariate metric derived from quantitative gait analysis that quantifies how much a gait cycle deviates from normative data. Average GDI calculated at the last 5 minutes of walking. Higher GDI indicates more normative walking.
Time frame: Last 5 minutes of treadmill walking during visit relative to baseline at start of walking.
Plan to share: Yes — De-identified IPD of each outcome measure will be made available on the NICHD Data and Specimen Hub (DASH) and reported in aggregate on clinicaltrials.gov.
Supporting information: Study protocol, Statistical analysis plan
Time frame: IPD will be made available 6 months following publication of study results.
Access criteria: Direct access with registration on NIH repository.
No publications or documents are linked to this record.
Started Aug 2026 (actual). Primary completion is estimated for Jun 2028, 21 months after the start.
Of 902 non-industry interventional studies with no phase under Cerebral Palsy, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 31. This study's planned 21 months is above that.
Counting every sponsor, half of 921 studies reached it within 12 months; a quarter within 5 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
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