An interventional study of Mobility Device and Spinal Stimulation in Cerebral Palsy, Stroke and Premature Birth, sponsored by University of Washington. Completed at 1 site in United States. Open to participants aged 4 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by University of Washington · Not applicable, Interventional, and Basic science
This research study will combine non-invasive spinal stimulation with an ankle exoskeleton to examine the acute impact of the stimulation on gait in children with cerebral palsy.
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 electrical spinal stimulation, impact movement mechanics in people with cerebral palsy while using an ankle exoskeleton to inform long-term studies and eventual implementation into clinical practice.
Mobility devices like ankle exoskeletons 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 spinal stimulation for individuals with cerebral palsy.
1,936 studies on the registry are indexed under Cerebral Palsy; 458 are open to participants now.
This study's enrollment of 10 is below the median of 34 across 1,431 interventional studies indexed under Cerebral Palsy.
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Exclusion Criteria:
Evaluation of individual and combined effects of mobility devices and spinal stimulation for individuals with neurologic disorders.
Device: Mobility Device · Device: Spinal Stimulation
Use of mobility device, an ankle exoskeleton, during walking sessions.
Also known as: Biomotum SPARK
A stimulator will be used non-invasively stimulate the spine at the neck and/or lower back (cervical and/or lum
Also known as: SpineX
Muscle Coordination
Level of co-contraction between the ankle plantarflexor and tibialis anterior muscles during gait monitored from electromyography recordings on the more-affected limb during the final minute of the walking trial.
Time frame: Co-contraction index during the last minute of a 5-minute walking trial at a single visit.
Modified Ashworth Scale of Spasticity
Change in summed score of spasticity from the gastrocnemius and soleus muscles on the more affected limb after completing the walking trial. Lower values indicate greater reductions in spasticity after trial. The maximum score on the Modified Ashworth Scale is a 5, indicating excessive spasticity and rigidity. The minimum score is 0 indicating normal muscle tone. This outcome measure sums the two ankle plantarflexor muscles on the more affected limb, including the gastrocnemius and soleus muscles, resulting in a maximum score of 10 and minimum score of 0 at a given time point.
Time frame: Physical exam conducted at the beginning and end of each visit.
Plantarflexor Muscle Strength
Change in maximum voluntary contraction level of the plantarflexor muscles in the more affect limb taken as the average of three trials where the participant exerts the maximum amount of force measured from a handheld dynamometer with verbal encouragement comparing trial with mobility device and spinal stimulation to mobility device alone. Lower values indicate greater reduction in strength after trial with mobility device and spinal stimulation versus mobility device alone.
Time frame: Physical exam conducted at the beginning and end of each visit.
Participants were recruited through the University of Washington and Seattle Children's Hospital via flyers, social media postings, and word of mouth at local clinics and community organizations. Recruitment started in the 2021 and was completed in 2023.
| Milestone | Cerebral Palsy |
|---|---|
| Started | 10 |
| No intervention | 10 |
| Exoskeleton only | 10 |
| Spinal stimulation only | 10 |
| Exoskeleton and spinal stimulation | 8 |
| Completed | 8 |
| Not completed | 2 |
| Withdrew: Withdrawal by subject | 2 |
Level of co-contraction between the ankle plantarflexor and tibialis anterior muscles during gait monitored from electromyography recordings on the more-affected limb during the final minute of the walking trial.
| mV/mV | No Intervention | Exoskeleton Only | Spinal Stimulation Only | Exoskeleton and Spinal Stimulation |
|---|---|---|---|---|
| Muscle Coordination | 65.26 ± 22.02 | 68.94 ± 15.91 | 62.86 ± 19.13 | 70.15 ± 14.19 |
Change in summed score of spasticity from the gastrocnemius and soleus muscles on the more affected limb after completing the walking trial. Lower values indicate greater reductions in spasticity after trial. The maximum score on the Modified Ashworth Scale is a 5, indicating excessive spasticity and rigidity. The minimum score is 0 indicating normal muscle tone. This outcome measure sums the two ankle plantarflexor muscles on the more affected limb, including the gastrocnemius and soleus muscles, resulting in a maximum score of 10 and minimum score of 0 at a given time point.
| Units on a Scale | No Intervention | Exoskeleton Only | Spinal Stimulation Only | Exoskeleton and Spinal Stimulation |
|---|---|---|---|---|
| Modified Ashworth Scale of Spasticity | -0.2 ± 0.8 | 0.2 ± 0.8 | 0 ± 0.5 | -0.3 ± 0.7 |
Change in maximum voluntary contraction level of the plantarflexor muscles in the more affect limb taken as the average of three trials where the participant exerts the maximum amount of force measured from a handheld dynamometer with verbal encouragement comparing trial with mobility device and spinal stimulation to mobility device alone. Lower values indicate greater reduction in strength after trial with mobility device and spinal stimulation versus mobility device alone.
| Newtons | No Intervention | Exoskeleton Only | Spinal Stimulation Only | Exoskeleton and Spinal Stimulation |
|---|---|---|---|---|
| Plantarflexor Muscle Strength | -4.1 ± 23.1 | 6.3 ± 14.1 | 4.9 ± 17.4 | -18.8 ± 24.2 |
Collected over Enrollment until final study visit, up to 8 weeks.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Neurologic Disorders | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Age, Continuous(years) | Cerebral Palsy |
|---|---|
| Mean | 10.4 ± 4.2 |
| Sex: Female, Male(Participants) | Cerebral Palsy |
|---|---|
| Female | 3 |
| Male | 7 |
| Race and Ethnicity Not Collected(Participants) | Cerebral Palsy |
|---|
| Height(cm) | Cerebral Palsy |
|---|---|
| Mean | 139.3 ± 23.9 |
| Weight(kg) | Cerebral Palsy |
|---|---|
| Mean | 37.9 ± 17.3 |
| Walking Speed(m/s) | Cerebral Palsy |
|---|---|
| Mean | 0.81 ± 0.29 |
PDFs hosted by the registry, ClinicalTrials.gov.
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