Cerebral PalsyNCT05520359
Spinal Stimulation and Mobility Devices
A study testing Mobility Device and Spinal Stimulation in people with Cerebral Palsy and Stroke, run by University of Washington at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 4 to 70 years
- Conditions the study is for
- Cerebral Palsy, Stroke, Premature Birth
- What is being tested?
- Mobility Device and Spinal Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Aug 2022to 13 May 2023
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transcutaneous Stimulation and Mobility Device Use for Individuals With Neurologic Conditions
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.
Read the 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 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.
- Conditions
- Cerebral Palsy, Stroke, Premature Birth, Hypoxic-Ischemic Encephalopathy, Periventricular Leukomalacia
- Being tested
- Mobility Device, Spinal Stimulation
- Keywords
- Pediatric, Mobility Aids, Assistive Technology, Spinal Stimulation
- Medical subject headings
- Cerebral Palsy, Stroke, Premature Birth, Hypoxia-Ischemia, Brain, Leukomalacia, Periventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobility DeviceDevice
Also called Biomotum SPARK
Use of mobility device, an ankle exoskeleton, during walking sessions.
Spinal StimulationDevice
Also called SpineX
A stimulator will be used non-invasively stimulate the spine at the neck and/or lower back (cervical and/or lum
| Study group | Role | What they receive |
|---|---|---|
| Neurologic Disorders | Experimental | Evaluation of individual and combined effects of mobility devices and spinal stimulation for individuals with neurologic disorders. Receives: Device: Mobility Device; Device: Spinal Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Co-contraction index during the last minute of a 5-minute walking trial at a single visit.
Secondary outcomes (2)
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.
Measured: 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.
Measured: Physical exam conducted at the beginning and end of each visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2022
- Study start4 Aug 2022
- Primary completion13 May 2023
- Study completion13 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized order of visits with individual and combined effects of mobility devices and spinal stimulation.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Seattle Children's Hospital
- Responsible party
- Principal investigator, Katherine Steele, University of Washington
- Investigators
- Katherine Steele, PHD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05520359
- Sponsor's protocol ID
- STUDY00014877
- Status last verified
- Aug 2026
- First submitted
- 22 Aug 2022
- Last updated
- 18 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No