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
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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)
Show all 10Show fewer
- 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
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Stimulation and Mobility Device Use for Individuals With Neurologic Conditions
- ClinicalTrials.gov ID
- NCT05520359
- Acronym / sponsor ID
- STUDY00014877
- Conditions
- Cerebral Palsy, Stroke, Premature Birth, Hypoxic-Ischemic Encephalopathy, Periventricular Leukomalacia
- Keywords
- Pediatric, Mobility Aids, Assistive Technology, Spinal Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Seattle Children's Hospital
- Study start
- 4 Aug 2022 (actual)
- Primary completion
- 13 May 2023 (actual)
- Study completion
- 13 May 2023 (actual)
- First posted
- 29 Aug 2022 (actual)
- Results
- Posted 18 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Randomized order of visits with individual and combined effects of mobility devices and spinal stimulation.
| Arm | Type | Receives |
|---|---|---|
| Neurologic Disorders | Experimental | Device: Mobility Device, Device: Spinal StimulationEvaluation of individual and combined effects of mobility devices and spinal stimulation for individuals with neurologic disorders. |
Who may qualify
- Ages
- 4 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobility DeviceAlso: Biomotum SPARKUse of mobility device, an ankle exoskeleton, during walking sessions. | Device | Neurologic Disorders |
| Spinal StimulationAlso: SpineXA stimulator will be used non-invasively stimulate the spine at the neck and/or lower back (cervical and/or lum | Device | Neurologic Disorders |
Primary outcome
Muscle Coordination
Time frame: Co-contraction index during the last minute of a 5-minute walking trial at a single visit.
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.
2 secondary outcomes
Modified Ashworth Scale of Spasticity
Time frame: Physical exam conducted at the beginning and end of each visit.
Plantarflexor Muscle Strength
Time frame: Physical exam conducted at the beginning and end of each visit.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Cerebral Palsy
Recruiting
Evaluating Long-term Use of a Pediatric Robotic Exoskeleton (P.REX/Agilik) to Improve Gait in Children With Movement Disorders
Cerebral Palsy, Muscular Dystrophy
RecruitingObservational study
Study of Sagittal Pelvic Statics in the Sitting Position in Children With Cerebral Palsy
Cerebral Palsy Infantile
Not yet recruitingObservational study
Turkish Translation, Cross-Cultural Adaptation, Validity, and Reliability of the ABILHAND-Kids Young CP Scale
Cerebral Palsy
RecruitingObservational study
Investigating Complex Neurodegenerative Disorders Related to Amyotrophic Lateral Sclerosis and Frontotemporal Dementia
Frontotemporal Dementia, Amyotrophic Lateral Sclerosis
Recruiting
Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Tablet-01)
Brainstem Stroke, ALS
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katherine Steele, PHD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle Coordination (time frame: Co-contraction index during the last minute of a 5-minute walking trial at a single visit.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.