Improving balance in children and young adults with Cerebral Palsy
Neuromotor Control During Postural Transitions in Children and Young Adults With Cerebral Palsy
This study is testing if light electrical stimulation can help improve balance in children and young adults with Cerebral Palsy during everyday activities like standing and walking.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 10 Years to 21 Years |
| Sex | All |
| Sponsor | University of Delaware Academic / other |
| Locations | 1 site (Newark, Delaware) |
| Trial ID | NCT05384990 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of light electrical stimulation on leg muscles and joints to enhance balance in individuals with Cerebral Palsy (CP) during daily activities such as standing up and walking. Participants aged 10-21 with a diagnosis of CP will undergo interventions involving stochastic resonance electric stimulation, which is designed to improve sensory perception without discomfort. The effectiveness of the treatment will be assessed through various balance and functional tests as participants perform tasks like standing from a stool and walking in a straight line.
Who should consider this trial
Good fit: Ideal candidates for this study are children and young adults aged 10-21 with a diagnosis of Cerebral Palsy who can stand up from a chair and walk.
Not a fit: Patients with severe scoliosis, joint instability, or other significant neurological or musculoskeletal disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve balance and reduce the risk of falls in children and young adults with Cerebral Palsy.
How similar studies have performed: While the specific approach of stochastic resonance electric stimulation is novel, similar studies exploring electrical stimulation for balance improvement in CP have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria for individuals with CP: 1. Age 10-21 2. Diagnosis of CP 3. GMFCS level I-II 4. Ability to stand up from a chair and start walking. 5. Migration index of proximal hip (MIGR) \< 40% femoral head covering in acetabulum 6. At least 0° passive dorsiflexion range of motion (ROM) 7. Sufficient visuoperceptual, cognitive and communication skills 8. Seizure-free or well-controlled seizures 9. No other neurological or musculoskeletal disorders (e.g. dystonia, severe scoliosis, hip instability 10. Ability to communicate pain or discomfort 11. Ability to assent/consent or obtain parent/guardian consent Exclusion Criteria for individuals with CP: 1. Scoliosis with primary curve \> 40% 2. Spinal fusions extending into pelvis 3. Lower Extremity joint instability or dislocation 4. Severe tactile hypersensitivity 5. Lower extremity botulinum injections in the past 6 months 6. Implanted medical device or metal contraindicative of the application of SR 7. Pregnancy (self-reported) 8. Severe lower extremity spasticity (Modified Ashworth Scale score of 4 or greater) 9. History of pulmonary disease limiting exercise tolerance (Asthma Control Test screen) 10. History of cardiac disease (American Heart Association screen) 11. Severely limited range of joint motion/ irreversible muscle contractures 12. Lower extremity surgery or significant injury within last 1 yr. Inclusionary criteria for typically developing volunteers: 1. Aged 10-21 years old 2. Ability to stand up from a chair and start walking without an assistive device or orthoses 3. Able to communicate discomfort during testing and can follow multi-step directions 4. Has not been diagnosed with any neurological or balance disorders 5. Seizure-free Exclusionary criteria for typically developing volunteers: 1. Diagnosis of CP 2. Significant scoliosis with primary curve \> 40° 3. Lower extremity surgery or fractures in the year prior testing 4. Joint instability or dislocation in the lower extremities 5. Severe tactile hypersensitivity 6. A history of selective dorsal root rhizotomy 7. Botulinum toxin injections in the lower extremities within the past 6 months 8. Marked visual or hearing deficits 9. Any embedded metal that may be contraindicated with application of SR 10. Severe spasticity of the lower extremity muscles (eg. a score of 4 on the Modified Ashworth) 11. Pregnancy (self-reported) 12. Severely limited joint range of motion/ irreversible muscle contractures that would not be candidates for soft-tissue surgery 13. Learning disabilities 14. History of neurological disorders 15. Balance and/or postural impairment
Where this trial is running
Newark, Delaware
- University of Delaware — Newark, Delaware, United States (Recruiting)
Study contacts
- Principal investigator: Samuel Lee, PT, PhD — University of Dealware
- Study coordinator: Samuel CK Lee, PT, PhD
- Email: slee@udel.edu
- Phone: 302-831-2450
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.