Cerebral PalsyNCT05384990
Sensorimotor Control During Postural Transitions in CP
A study testing Stochastic Resonance Electric Stimulation in people with Cerebral Palsy, run by University of Delaware at 1 site in United States.
Trial summary
The purpose of this study is to investigate whether a light electrical stimulation to leg muscles and joints can help people with Cerebral Palsy (CP) maintain balance during everyday tasks such as getting up from a chair and walking. Read more about this study
- Who is it for?
- Ages 10 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Stochastic Resonance Electric Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2024to 30 Dec 2026
- 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 10 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age 10-21
- Diagnosis of CP
- GMFCS level I-II
- Ability to stand up from a chair and start walking.
- Migration index of proximal hip (MIGR) < 40% femoral head covering in acetabulum
- At least 0° passive dorsiflexion range of motion (ROM)
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- Sufficient visuoperceptual, cognitive and communication skills
- Seizure-free or well-controlled seizures
- No other neurological or musculoskeletal disorders (e.g. dystonia, severe scoliosis, hip instability
- Ability to communicate pain or discomfort
- Ability to assent/consent or obtain parent/guardian consent
Who cannot join
- Scoliosis with primary curve > 40%
- Spinal fusions extending into pelvis
- Lower Extremity joint instability or dislocation
- Severe tactile hypersensitivity
- Lower extremity botulinum injections in the past 6 months
- Implanted medical device or metal contraindicative of the application of SR
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- Pregnancy (self-reported)
- Severe lower extremity spasticity (Modified Ashworth Scale score of 4 or greater)
- History of pulmonary disease limiting exercise tolerance (Asthma Control Test screen)
- History of cardiac disease (American Heart Association screen)
- Severely limited range of joint motion/ irreversible muscle contractures
- Lower extremity surgery or significant injury within last 1 yr.
- Inclusionary criteria for typically developing volunteers:
- Aged 10-21 years old
- Ability to stand up from a chair and start walking without an assistive device or orthoses
- Able to communicate discomfort during testing and can follow multi-step directions
- Has not been diagnosed with any neurological or balance disorders
- Seizure-free
- Exclusionary criteria for typically developing volunteers:
- Diagnosis of CP
- Significant scoliosis with primary curve > 40°
- Lower extremity surgery or fractures in the year prior testing
- Joint instability or dislocation in the lower extremities
- Severe tactile hypersensitivity
- A history of selective dorsal root rhizotomy
- Botulinum toxin injections in the lower extremities within the past 6 months
- Marked visual or hearing deficits
- Any embedded metal that may be contraindicated with application of SR
- Severe spasticity of the lower extremity muscles (eg. a score of 4 on the Modified Ashworth)
- Pregnancy (self-reported)
- Severely limited joint range of motion/ irreversible muscle contractures that would not be candidates for soft-tissue surgery
- Learning disabilities
- History of neurological disorders
- Balance and/or postural impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neuromotor Control During Postural Transitions in Children and Young Adults With Cerebral Palsy
The purpose of this study is to investigate whether a light electrical stimulation to leg muscles and joints can help people with Cerebral Palsy (CP) maintain balance during everyday tasks such as getting up from a chair and walking. Children and young adults with CP can have trouble with daily tasks such as standing up, sitting down on the chair and turning. The difficulty in maintaining balance sometimes lead to falls. This raises risk of disability in CP as children age into teens and adults. Current treatments are not very effective. In this study, children and young adults will be asked to stand up from a stool, walk in a straight line, turn, walk back and sit down on the stool. Participants will receive electrical stimulation at a very low intensity that cannot be felt to help increase their sensory perception. The investigators will evaluate treatment by testing balance, and other functional measures.
- Conditions
- Cerebral Palsy
- Being tested
- Stochastic Resonance Electric Stimulation
- Keywords
- Balance Control, Stochastic Resonance, Postural Transitions
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stochastic Resonance Electric StimulationDevice
Subjects will be asked to perform postural transitions like sit to stand, gait initiation, sit to walk and Timed up and the Go (TUG) functional test. This will entail a subsensory electrical signal with a white noise frequency distribution. Proprioceptive SR electrical stimulation will be delivered by BIOPAC Systems, Inc. stimulators that are current limited to deliver less than 10 milli ampere of current. Electrical stimulation will be delivered to muscles and joints along the legs and hips. The stimulation intensity will be very low, below the sensory threshold of the participant.
| Study group | Role | What they receive |
|---|---|---|
| Stochastic Resonance stimulation | Experimental | During this condition, participants will perform postural transitions like sit to stand, gait initiation, sit to walk and Timed Up and Go test while receiving stochastic resonance stimulation on legs and hip. Receives: Device: Stochastic Resonance Electric Stimulation |
| No Stochastic Resonance stimulation | No intervention | During this condition, participants will perform postural transitions like sit to stand, gait initiation, sit to walk and Timed Up and Go test without receiving any electrical stimulation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in COM
Change in the Center of Mass (COM) trajectories while performing various activities.
Measured: 2 assessment points: Baseline - pre stimulation COM, and at the end of the session with stimulation (Day 1)- Post stimulation COM
Change in COP
Change in the Center of Pressure (COP) trajectories while performing various activities.
Measured: 2 assessment points: Baseline - pre stimulation COP, and at the end of the session with stimulation (Day 1)- Post stimulation COP
Total time
Time taken to complete the task.
Measured: Baseline, Post Stimulation (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2022
- Study start1 Apr 2024
- Primary completion30 May 2025
- Study completion30 Dec 2026 (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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Cross sectional study in children with CP and age matched TD (typical developing). Each group will undergo two stimulation conditions, stochastic resonance (SR) stimulation and a no stochastic resonance (noSR) condition while performing postural Transitions.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Delaware
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samuel Lee, University of Delaware
- Investigators
- Samuel Lee, PT, PhD, Principal investigator, University of Dealware
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05384990
- Sponsor's protocol ID
- 1759703
- Status last verified
- Jun 2026
- First submitted
- 11 May 2022
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromotor Control During Postural Transitions in Children and Young Adults With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05384990
- Acronym / sponsor ID
- 1759703
- Conditions
- Cerebral Palsy
- Keywords
- Balance Control, Stochastic Resonance, Postural Transitions
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University of DelawareUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 23 May 2022 (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.
The purpose of this study is to investigate whether a light electrical stimulation to leg muscles and joints can help people with Cerebral Palsy (CP) maintain balance during everyday tasks such as getting up from a chair and walking. Children and young adults with CP can have trouble with daily tasks such as standing up, sitting down on the chair and turning. The difficulty in maintaining balance sometimes lead to falls. This raises risk of disability in CP as children age into teens and adults. Current treatments are not very effective. In this study, children and young adults will be asked to stand up from a stool, walk in a straight line, turn, walk back and sit down on the stool. Participants will receive electrical stimulation at a very low intensity that cannot be felt to help increase their sensory perception. The investigators will evaluate treatment by testing balance, and other functional measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Cross sectional study in children with CP and age matched TD (typical developing). Each group will undergo two stimulation conditions, stochastic resonance (SR) stimulation and a no stochastic resonance (noSR) condition while performing postural Transitions.
| Arm | Type | Receives |
|---|---|---|
| Stochastic Resonance stimulation | Experimental | Device: Stochastic Resonance Electric StimulationDuring this condition, participants will perform postural transitions like sit to stand, gait initiation, sit to walk and Timed Up and Go test while receiving stochastic resonance stimulation on legs and hip. |
| No Stochastic Resonance stimulation | No intervention | –During this condition, participants will perform postural transitions like sit to stand, gait initiation, sit to walk and Timed Up and Go test without receiving any electrical stimulation. |
Who may qualify
- Ages
- 10 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- Age 10-21
- Diagnosis of CP
- GMFCS level I-II
- Ability to stand up from a chair and start walking.
- Migration index of proximal hip (MIGR) < 40% femoral head covering in acetabulum
Key exclusion criteria (34 listed)
- Scoliosis with primary curve > 40%
- Spinal fusions extending into pelvis
- Lower Extremity joint instability or dislocation
- Severe tactile hypersensitivity
- Lower extremity botulinum injections in the past 6 months
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 |
|---|---|---|
| Stochastic Resonance Electric StimulationSubjects will be asked to perform postural transitions like sit to stand, gait initiation, sit to walk and Timed up and the Go (TUG) functional test. This will entail a subsensory electrical signal with a white noise frequency distribution. Proprioceptive SR electrical stimulation will be delivered by BIOPAC Systems, Inc. stimulators that are current limited to deliver less than 10 milli ampere of current. Electrical stimulation will be delivered to muscles and joints along the legs and hips. The stimulation intensity will be very low, below the sensory threshold of the participant. | Device | Stochastic Resonance stimulation |
Primary outcome
Change in COM
Time frame: 2 assessment points: Baseline - pre stimulation COM, and at the end of the session with stimulation (Day 1)- Post stimulation COM
Change in the Center of Mass (COM) trajectories while performing various activities.
Change in COP
Time frame: 2 assessment points: Baseline - pre stimulation COP, and at the end of the session with stimulation (Day 1)- Post stimulation COP
Change in the Center of Pressure (COP) trajectories while performing various activities.
Total time
Time frame: Baseline, Post Stimulation (Day 1)
Time taken to complete the task.
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 11 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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.
Samuel Lee, PT, PhD principal investigator
University of Dealware
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stochastic Resonance Electric Stimulation in people with Cerebral Palsy, run by University of Delaware 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 11 inclusion and 34 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: under way, not looking for participants, as of the sponsor's last update on 11 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?
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?
Change in COM (time frame: 2 assessment points: Baseline - pre stimulation COM, and at the end of the session with stimulation (Day 1)- Post stimulation COM). The study lists 3 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 11 Jun 2026.