Cerebral PalsyNCT05899153
Gait Adaptation and Biofeedback for Cerebral Palsy
A study testing Biomotum Spark: Robotic ankle resistance, Audiovisual Biofeedback and Multilevel Orthopedic Surgery in people with Cerebral Palsy, run by University of Washington at 1 site in United States.
Trial summary
This research aims to evaluate walking function in children with cerebral palsy (CP). The researchers want to understand how children with CP adapt and learn new ways of moving. They have previously found that measuring how a person controls their muscles is important for assessing walking ability and response to… Read more about this study
- Who is it for?
- Ages 7 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Biomotum Spark: Robotic ankle resistance, Audiovisual Biofeedback and Multilevel Orthopedic Surgery
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Nov 2023to 1 Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 7 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Diagnosis of bilateral cerebral palsy that impacts both legs
- Gross Motor Functional Classification System Level II
- No surgery or lower-extremity injuries 12 months prior to enrollment
- No botulinum toxin injections in prior 3 months
- No prior selective dorsal rhizotomy surgery
- No history of seizures or cardiac conditions that would preclude walking on a treadmill for 20 minutes
- No current pain that hinders walking
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Alyssa Spomer, PhD contact
United States1 site, 1 recruiting
- Recruiting
Gillette Children's
Saint Paul, Minnesota, 55101
Alyssa Spomer, PhD, 651-229-3904, AlyssaMSpomer@gillettechildrens.com
Michael H Schwartz, PhD, MSchwartz@gillettechildrens.com
About this study
Official title: Quantifying Patient-specific Changes in Neuromuscular Control in Cerebral Palsy: Adaptation and Biofeedback During Gait
This research aims to evaluate walking function in children with cerebral palsy (CP). The researchers want to understand how children with CP adapt and learn new ways of moving. They have previously found that measuring how a person controls their muscles is important for assessing walking ability and response to interventions. In these studies, they will adjust the treadmill belt speeds and/or provide real-time feedback to evaluate how a child can alter their movement. The feedback will include a wearable exoskeleton that provides resistance to the ankle and audio and visual cues based on sensors that record muscle activity. This research will investigate three goals: first, to measure how children with CP adapt their walking; second, to see if either repeated training or orthopedic surgery can improve adaptation rates; and third, to determine if individual differences in adaptation relate to improvements in walking function after treatment. This research will help develop better treatments to enhance walking capacity and performance for children with CP.
Read the detailed description
Prior research has shown that children with cerebral palsy (CP) use simplified motor control strategies compared to nondisabled (ND) peers, and that these differences in motor control are associated with walking function. While we can quantify motor control during activities like walking, the processes by which a child with CP adapts and learns new movement patterns are poorly understood.
This research will use two paradigms to evaluate adaptation and motor learning in children with CP: walking on a split-belt treadmill and responding to multimodal biofeedback. Walking on a split-belt treadmill, which has two belts set at different speeds to induce asymmetry during walking, has been commonly used to evaluate adaptation in other clinical populations. Responding to multimodal feedback can also be used to evaluate an individual's capacity to adapt their walking pattern. This research will use a real-time multimodal feedback system that targets plantarflexor activity, a key muscle group that is often impaired in CP. Sensorimotor feedback will be provided using a lightweight, body-worn robotic device that provides adaptive ankle resistance and step-by-step audiovisual feedback will be provided based on muscle activity from the plantarflexors using a visual display and audible tone. This research will quantify adaptation rate (e.g., change in soleus activity or step length symmetry) in response to these perturbations, and observe the impact of repeated practice or orthopedic surgery on walking function (e.g., change in walking speed). The specific aims are to:
Aim-1: Quantify adaptation rates in children with CP. We will quantify adaptation rate in response to three perturbation experiments: split-belt treadmill walking, sensorimotor feedback, and audiovisual feedback. The primary hypotheses are that children with CP will exhibit reduced adaptation rates compared to ND peers, and that adaptation rates will be associated with function (Gross Motor Function Measure, GMFM-66).
Aim-2: Determine whether adaptation rates change in response to repeated multimodal feedback training. We will evaluate children with CP who undergo six weeks of multimodal biofeedback training (20-min, 2x/week) or orthopedic surgery. The primary hypothesis is that multimodal feedback training will produce greater changes in adaptation rates than orthopedic surgery.
Aim-3: Determine whether changes in gait after treatment are associated with adaptation rates. Gait analysis will be performed to determine whether baseline adaptation rates are associated with changes in gait after treatment. The primary hypotheses are that baseline adaptation rates will be associated with changes in muscle, joint, and whole-body performance.
- Conditions
- Cerebral Palsy
- Being tested
- Biomotum Spark: Robotic ankle resistance, Audiovisual Biofeedback, Multilevel Orthopedic Surgery
- Keywords
- Gait, Rehabilitation
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biomotum Spark: Robotic ankle resistanceDevice
Robotic ankle exoskeleton that provides resistance to ankle plantarflexion.
Audiovisual BiofeedbackDevice
Electromyography recordings from the plantarflexor muscles are used to provide audio feedback via a sound that plays when muscle activity is above target and a visual bar that displays real-time muscle activity.
Multilevel Orthopedic SurgeryProcedure or surgery
Musculoskeletal surgeries to address alignment, contracture, and other lower-extremity impairments. This study does not impact surgical decision making but evaluates changes in gait before and after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Orthopedic Surgery | Experimental | Participants who have been scheduled for lower-extremity, multilevel orthopedic surgery will be assessed before and 9-18 months after surgery to evaluate changes in gait and adaptation rates. Receives: Procedure: Multilevel Orthopedic Surgery |
| Audiovisual + Sensorimotor Biofeedback | Experimental | Participants will complete 12 sessions (20 minutes of walking on a treadmill) over a 6-8 week period while receiving both audiovisual and sensorimotor biofeedback. Sensorimotor biofeedback will be provided with an ankle exoskeleton that provides resistance to ankle plantarflexion during the stance phase of gait. The visual feedback will be provided on a screen with a bar showing real-time muscle activity and the audio feedback will be a sound played when they reach the target level of muscle activity from the plantarflexors. Receives: Device: Biomotum Spark: Robotic ankle resistance; Device: Audiovisual Biofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Soleus Muscle Activity
Average stance-phase magnitude of soleus muscle activity from electromyography recording measured during gait at 1-month follow-up.
Measured: Change from baseline to intervention follow-up, assessed up to 18 months
Change in Peak Ankle Power
Average peak ankle power evaluated during gait.
Measured: Change from baseline to intervention follow-up, assessed up to 18 months
Change in Self-Selected Walking Speed
Average overground walking speed.
Measured: Change from baseline after intervention.
Change in Dynamic Motor Control During Walking (Walk-DMC)
The total variance account for by one muscle synergy calculated from electromyography recordings during gait.
Measured: Change from baseline to intervention follow-up, assessed up to 18 months
Change in Gait Deviation Index (GDI)
Deviation in gait kinematics compared to nondisabled gait.
Measured: Change from baseline to intervention follow-up, assessed up to 18 months
Change in Gross Motor Function Measure - 66 (GMFM-66) Parts D & E
Assessment tool designed and evaluated to measure changes in gross motor function. Parts D \& E focus on standing, walking, jumping, and running function.
Measured: Change from baseline to intervention follow-up, assessed up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start28 Nov 2023
- Primary completion1 May 2028 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), Gillette Children's Specialty Healthcare, Northern Arizona University
- Responsible party
- Principal investigator, Katherine Steele, University of Washington
- Investigators
- Katherine M Steele, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05899153
- Sponsor's protocol ID
- STUDY00015348
- Other IDs
- R01NS091056
- Status last verified
- Jun 2026
- First submitted
- 24 May 2023
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De-identified participant data from gait analysis and outcome measures will be provided on a public data repository.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantifying Patient-specific Changes in Neuromuscular Control in Cerebral Palsy: Adaptation and Biofeedback During Gait
- ClinicalTrials.gov ID
- NCT05899153
- Acronym / sponsor ID
- STUDY00015348
- Conditions
- Cerebral Palsy
- Keywords
- Gait, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), Gillette Children's Specialty Healthcare, Northern Arizona University
- Study start
- 28 Nov 2023 (actual)
- Primary completion
- 1 May 2028 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 12 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research aims to evaluate walking function in children with cerebral palsy (CP). The researchers want to understand how children with CP adapt and learn new ways of moving. They have previously found that measuring how a person controls their muscles is important for assessing walking ability and response to interventions. In these studies, they will adjust the treadmill belt speeds and/or provide real-time feedback to evaluate how a child can alter their movement. The feedback will include a wearable exoskeleton that provides resistance to the ankle and audio and visual cues based on sensors that record muscle activity. This research will investigate three goals: first, to measure how children with CP adapt their walking; second, to see if either repeated training or orthopedic surgery can improve adaptation rates; and third, to determine if individual differences in adaptation relate to improvements in walking function after treatment. This research will help develop better treatments to enhance walking capacity and performance for children with CP.
Detailed description
Prior research has shown that children with cerebral palsy (CP) use simplified motor control strategies compared to nondisabled (ND) peers, and that these differences in motor control are associated with walking function. While we can quantify motor control during activities like walking, the processes by which a child with CP adapts and learns new movement patterns are poorly understood.
This research will use two paradigms to evaluate adaptation and motor learning in children with CP: walking on a split-belt treadmill and responding to multimodal biofeedback. Walking on a split-belt treadmill, which has two belts set at different speeds to induce asymmetry during walking, has been commonly used to evaluate adaptation in other clinical populations. Responding to multimodal feedback can also be used to evaluate an individual's capacity to adapt their walking pattern. This research will use a real-time multimodal feedback system that targets plantarflexor activity, a key muscle group that is often impaired in CP. Sensorimotor feedback will be provided using a lightweight, body-worn robotic device that provides adaptive ankle resistance and step-by-step audiovisual feedback will be provided based on muscle activity from the plantarflexors using a visual display and audible tone. This research will quantify adaptation rate (e.g., change in soleus activity or step length symmetry) in response to these perturbations, and observe the impact of repeated practice or orthopedic surgery on walking function (e.g., change in walking speed). The specific aims are to:
Aim-1: Quantify adaptation rates in children with CP. We will quantify adaptation rate in response to three perturbation experiments: split-belt treadmill walking, sensorimotor feedback, and audiovisual feedback. The primary hypotheses are that children with CP will exhibit reduced adaptation rates compared to ND peers, and that adaptation rates will be associated with function (Gross Motor Function Measure, GMFM-66).
Aim-2: Determine whether adaptation rates change in response to repeated multimodal feedback training. We will evaluate children with CP who undergo six weeks of multimodal biofeedback training (20-min, 2x/week) or orthopedic surgery. The primary hypothesis is that multimodal feedback training will produce greater changes in adaptation rates than orthopedic surgery.
Aim-3: Determine whether changes in gait after treatment are associated with adaptation rates. Gait analysis will be performed to determine whether baseline adaptation rates are associated with changes in gait after treatment. The primary hypotheses are that baseline adaptation rates will be associated with changes in muscle, joint, and whole-body performance.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Orthopedic Surgery | Experimental | Procedure: Multilevel Orthopedic SurgeryParticipants who have been scheduled for lower-extremity, multilevel orthopedic surgery will be assessed before and 9-18 months after surgery to evaluate changes in gait and adaptation rates. |
| Audiovisual + Sensorimotor Biofeedback | Experimental | Device: Biomotum Spark: Robotic ankle resistance, Device: Audiovisual BiofeedbackParticipants will complete 12 sessions (20 minutes of walking on a treadmill) over a 6-8 week period while receiving both audiovisual and sensorimotor biofeedback. Sensorimotor biofeedback will be provided with an ankle exoskeleton that provides resistance to ankle plantarflexion during the stance phase of gait. The visual feedback will be provided on a screen with a bar showing real-time muscle activity and the audio feedback will be a sound played when they reach the target level of muscle activity from the plantarflexors. |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Diagnosis of bilateral cerebral palsy that impacts both legs
- Gross Motor Functional Classification System Level II
- No surgery or lower-extremity injuries 12 months prior to enrollment
- No botulinum toxin injections in prior 3 months
- No prior selective dorsal rhizotomy surgery
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Biomotum Spark: Robotic ankle resistanceRobotic ankle exoskeleton that provides resistance to ankle plantarflexion. | Device | Audiovisual + Sensorimotor Biofeedback |
| Audiovisual BiofeedbackElectromyography recordings from the plantarflexor muscles are used to provide audio feedback via a sound that plays when muscle activity is above target and a visual bar that displays real-time muscle activity. | Device | Audiovisual + Sensorimotor Biofeedback |
| Multilevel Orthopedic SurgeryMusculoskeletal surgeries to address alignment, contracture, and other lower-extremity impairments. This study does not impact surgical decision making but evaluates changes in gait before and after surgery. | Procedure or surgery | Orthopedic Surgery |
Primary outcome
Change in Soleus Muscle Activity
Time frame: Change from baseline to intervention follow-up, assessed up to 18 months
Average stance-phase magnitude of soleus muscle activity from electromyography recording measured during gait at 1-month follow-up.
Change in Peak Ankle Power
Time frame: Change from baseline to intervention follow-up, assessed up to 18 months
Average peak ankle power evaluated during gait.
Change in Self-Selected Walking Speed
Time frame: Change from baseline after intervention.
Average overground walking speed.
Change in Dynamic Motor Control During Walking (Walk-DMC)
Time frame: Change from baseline to intervention follow-up, assessed up to 18 months
The total variance account for by one muscle synergy calculated from electromyography recordings during gait.
Change in Gait Deviation Index (GDI)
Time frame: Change from baseline to intervention follow-up, assessed up to 18 months
Deviation in gait kinematics compared to nondisabled gait.
Change in Gross Motor Function Measure - 66 (GMFM-66) Parts D & E
Time frame: Change from baseline to intervention follow-up, assessed up to 18 months
Assessment tool designed and evaluated to measure changes in gross motor function. Parts D \& E focus on standing, walking, jumping, and running function.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Individual participant dataSharing planned: Yes. De-identified participant data from gait analysis and outcome measures will be provided on a public data repository.
Related trials for Cerebral Palsy
Not yet recruitingObservational study
Changes in Land-Based Motor Function After Routine Hydrotherapy in Children With Cerebral Palsy
Cerebral Palsy
Recruiting
MindEx: A Novel, Multifocal, Cognitive Brain-Machine Interface System
Paralysis; Quadriplegic, Quadraplegia
Not yet recruiting
EFFECT OF ROBOTIC GLOVES TRAINING ON UPPER LIMB COORDINATION, SELECTIVE MOTOR CONTROL AND ACTIVITIES OF DAILY LIVING IN CHILDREN WITH HEMIPARETIC CEREBRAL PALSY.
Hemiplegic Cerebral Palsy
RecruitingObservational study
Investigating Complex Neurodegenerative Disorders Related to Amyotrophic Lateral Sclerosis and Frontotemporal Dementia
Frontotemporal Dementia, Amyotrophic Lateral Sclerosis
Recruiting
Combined Popliteal and Adductor Canal Blocks for Postoperative Analgesia in Children With Cerebral Palsy
Cerebral Palsy, Postoperative Pain
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.
Alyssa Spomer, PhD contact
Katherine M 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 Biomotum Spark: Robotic ankle resistance, Audiovisual Biofeedback and Multilevel Orthopedic Surgery in people with Cerebral Palsy, 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 7 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 8 Jun 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katherine M Steele, PhD (206-685-2390, kmsteele@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Soleus Muscle Activity (time frame: Change from baseline to intervention follow-up, assessed up to 18 months). The study lists 6 primary outcomes in all. 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 8 Jun 2026.