36 Participants Needed

Electric Stimulation for Cerebral Palsy

SC
KV
Overseen ByKhushboo Verma, PT
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: University of Delaware
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it mentions that participants should be seizure-free or have well-controlled seizures, which might imply that continuing seizure medication is allowed.

What data supports the effectiveness of the treatment Stochastic Resonance Electric Stimulation for cerebral palsy?

Research shows that Stochastic Resonance Stimulation can improve balance in children with cerebral palsy by enhancing sensory input detection. Similar treatments have also been effective in improving balance in elderly individuals and those with diabetic neuropathy or after a stroke.12345

Is electrical stimulation safe for use in humans?

Research shows that electrical stimulation, including types like Neuromuscular Electrical Stimulation (NMES) and Functional Electrical Stimulation (FES), is generally safe and well-tolerated in humans, including children with disabilities. Reports of direct adverse reactions are rare, and safety principles have been established over more than 40 years of research.678910

How is the treatment Stochastic Resonance Electric Stimulation unique for cerebral palsy?

Stochastic Resonance Electric Stimulation is unique for cerebral palsy as it uses a specific level of noise to enhance the body's ability to detect and respond to weak sensory signals, improving balance and postural control, which is a novel approach for this condition.1251112

What is the purpose of this trial?

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.

Research Team

SL

Samuel Lee, PT, PhD

Principal Investigator

University of Dealware

Eligibility Criteria

This trial is for children and young adults aged 8-24 with Cerebral Palsy (CP), specifically those who can stand up from a chair and walk but have difficulty maintaining balance. They should not have other neurological or musculoskeletal disorders, be seizure-free or have well-controlled seizures, and possess sufficient cognitive skills to communicate discomfort.

Inclusion Criteria

You have mild to moderate motor function.
You do not have any diagnosed neurological or balance disorders.
You must be between 8 and 24 years old.
See 10 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants perform postural transitions with and without stochastic resonance stimulation to evaluate balance and functional measures

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2-4 weeks

Treatment Details

Interventions

  • Stochastic Resonance Electric Stimulation
Trial Overview The study tests if light electrical stimulation called Stochastic Resonance Electric Stimulation on leg muscles helps improve balance during tasks like standing up, walking, turning around, and sitting down. Participants will perform these activities while receiving imperceptible electric stimulation to enhance sensory perception.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Stochastic Resonance stimulationExperimental Treatment1 Intervention
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.
Group II: No Stochastic Resonance stimulationActive Control1 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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Delaware

Lead Sponsor

Trials
167
Recruited
25,700+

Findings from Research

A new electrical stimulator using stochastic resonance has been developed to potentially enhance postural control in elderly individuals, those with diabetic neuropathy, and stroke patients.
The device features four programmable channels and two stimulation modes, allowing for tailored treatment, which may improve balance and stability in these populations.
A microprocessor-based multichannel subsensory stochastic resonance electrical stimulator.Chang, GC.[2020]
In a study involving 15 healthy subjects, low-amplitude stochastic vestibular electrical stimulation significantly improved balance performance by 5-26%, demonstrating the effectiveness of stochastic resonance in enhancing stability.
The optimal stimulation amplitude for improving balance was found to be between ±100 to ±400 μA, suggesting potential applications for a wearable device to assist individuals with balance issues due to aging or disabilities.
Improving balance function using vestibular stochastic resonance: optimizing stimulus characteristics.Mulavara, AP., Fiedler, MJ., Kofman, IS., et al.[2021]
Neuromuscular electrical stimulation (NMES) significantly improves mobility in children with spastic cerebral palsy, as shown by greater walking speed and enhanced performance in standing, running, and jumping activities based on a meta-analysis of 14 randomized controlled trials involving 421 patients.
The treatment was found to be safe for children with spastic cerebral palsy, indicating that NMES can be a beneficial therapeutic option alongside conventional physical therapy.
Effectiveness of neuromuscular electrical stimulation in improving mobility in children with cerebral palsy: A systematic review and meta-analysis of randomized controlled trials.Chen, YH., Wang, HY., Liao, CD., et al.[2022]

References

A microprocessor-based multichannel subsensory stochastic resonance electrical stimulator. [2020]
Improving balance function using vestibular stochastic resonance: optimizing stimulus characteristics. [2021]
Effectiveness of neuromuscular electrical stimulation in improving mobility in children with cerebral palsy: A systematic review and meta-analysis of randomized controlled trials. [2022]
Subthreshold electrical noise alters walking balance control in individuals with cerebral palsy. [2023]
Stochastic resonance stimulation improves balance in children with cerebral palsy: a case control study. [2019]
A stochastic model of knee angle in response to electrical stimulation of the quadriceps and hamstrings muscles. [2011]
Functional electrical stimulation for neuromuscular applications. [2022]
Stochastically modulated inter-pulse intervals to increase the efficiency of functional electrical stimulation cycling. [2022]
Does therapeutic electrical stimulation improve function in children with disabilities? A comprehensive literature review. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Magnetic Field Reference Levels for Arbitrary Periodic Waveforms for Prevention of Peripheral Nerve Stimulation. [2018]
11.United Statespubmed.ncbi.nlm.nih.gov
Stochastic Resonance Effects on Apnea, Bradycardia, and Oxygenation: A Randomized Controlled Trial. [2020]
12.United Statespubmed.ncbi.nlm.nih.gov
Stochastic resonance in the motor system: effects of noise on the monosynaptic reflex pathway of the cat spinal cord. [2007]
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