Status:
ACTIVE_NOT_RECRUITING
Sensorimotor Control During Postural Transitions in CP
Lead Sponsor:
University of Delaware
Conditions:
Cerebral Palsy
Eligibility:
All Genders
10-21 years
Phase:
NA
Brief 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 get...
Eligibility Criteria
Inclusion
- Inclusion Criteria for individuals with CP:
- 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)
- 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
- Exclusion Criteria for individuals with CP:
- 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
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2025
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT05384990
Start Date
April 1 2024
End Date
December 30 2025
Last Update
November 14 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Delaware
Newark, Delaware, United States, 19713