CompletedNot Applicable

Remote Ischemic Conditioning, Bimanual Skill Learning, and Corticospinal Excitability

United States51 participantsStarted 2021-12-18

Plain-language summary

Unilateral cerebral palsy (UCP) is a leading cause of childhood disability. An early brain injury impairs the upper extremity function, bimanual coordination, and impacts the child's independence. The existing therapeutic interventions have higher training doses and modest effect sizes. Thus, there is a critical need to find an effective priming agent to enhance bimanual skill learning in children with UCP. This study aims to determine the effects of a novel priming agent, remote ischemic conditioning (RIC), when paired with intensive bimanual skill training to enhance bimanual skill learning and to augment skill dependent plasticity in children with UCP.

Who can participate

Age range6 Years – 16 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Children diagnosed with unilateral cerebral palsy, ages 6-16 years * Manual Ability Classification System (MACS) levels I-III * Ability to complete a stack of 3 cups in 2 minutes * Mainstream in school and has sufficient cognition to follow the experiment instructions Exclusion Criteria: * Children with other developmental disabilities such as autism, developmental coordination disorders, etc. * Children with absent active motor threshold * Children with cognitive deficits or communication problem * Children with known cardiorespiratory and vascular dysfunctions * Children with metabolic disorders, neoplasm, hydrocephalus * Children who are receiving other adjunct therapies such as rTMS and tDCS * Children with seizures and on anti-seizure medications * Children with metal implants and incompatible medical devices for MRI scans

What they're measuring

Change in Assisting Hand Assessment

Timeframe: Baseline and 1 week

Change in Bimanual Task Performance

Timeframe: Baseline and 1 week

Change in Resting and Active Motor Thresholds

Timeframe: Baseline and 1 week

Change in Stimulus-response curves

Timeframe: Baseline and 1 week

Trial details

NCT IDNCT05355883

SponsorEast Carolina University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-31

View on ClinicalTrials.gov More Unilateral Cerebral Palsy trials

Plain-language summary

Who can participate

Age range6 Years – 16 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.