Clinical trial NCT04598711: Ischemic Conditioning to Enhance Function (I-C-FUN) in Children With Cerebral Palsy
Official title: Effects of Remote Limb Ischemic Conditioning to Enhance Muscle Power, Dynamic Balance, and Walking Performance in Children With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Lead sponsor: East Carolina University
Sponsor class: OTHER
First posted: 2020-10-22
Enrollment: 24
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double blinded, randomized controlled trial
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to determine if remote limb ischemic conditioning (RLIC) can increase skeletal muscle power, enhance learning of motor (dynamic balance) task, and improve walking performance in children with cerebral palsy (CP).

Detailed description: Ischemic conditioning is a phenomenon in which an organ exposed to a controlled, short-term, local, sublethal ischemia protects from subsequent ischemia. Remote ischemic conditioning is another more practical approach where transient ischemia and reperfusion applied to a remote organ or tissue, protects other organs or tissues from further episodes of lethal ischemia/reperfusion injury. Remote limb ischemic conditioning (RLIC) is a clinically feasible way of performing remote ischemic conditioning where alternating, brief ischemia and reperfusion is delivered with cyclic inflation and deflation of a blood pressure cuff on the arm or leg.

The overall goal of this research is to use ischemic conditioning to enhance muscle power, motor leaning, and mobility in children with CP. Our previous work demonstrated that when paired with strength training, RLIC improved muscle strength and activation in healthy, young adults and motor learning in healthy older adults. The current study extends that work to determine if RLIC enhances muscle power, dynamic balance, and walking performance in children with CP. This Phase II study will yield the necessary information to design and execute subsequent randomized controlled trials in children with CP as well as other neurological conditions.

Eligibility criteria: Inclusion Criteria:

1. Children diagnosed with unilateral or diplegia cerebral palsy (CP)
2. Gross Motor Function Classification System (GMFCS) levels I-III

Exclusion Criteria:

1. Children with other developmental disabilities such as autism, developmental coordination disorders, etc.
2. Children with cognitive deficits or communication problem
3. Children with balance disorders such as vestibular disorders, posterior fossa tumors etc.
4. Children with known cardiorespiratory dysfunctions
5. Children who are receiving other adjunct therapies such as TMS, tDCS, vagal nerve stimulation
6. Presence of lower extremity condition, injury, or surgery which could compromise conditioning and training
7. Children with sickle cell disease

Primary outcomes:
measure: Change in Peak knee extension power
timeFrame: Pre-intervention to 1 month post-intervention follow-up
measure: Change in Balance Score
timeFrame: Pre-intervention to 1 month post-intervention follow-up
measure: Change in Walking Speed
timeFrame: Pre-intervention to 1 month post-intervention follow-up
Secondary outcomes:
measure: Quadriceps Electromyography
timeFrame: Pre-intervention to 1 month post-intervention follow-up
measure: Gait Analysis
timeFrame: Pre-intervention to 1 month post-intervention follow-up
measure: Lower limb activity
timeFrame: Pre-intervention to 1 month post-intervention follow-up
Other outcomes:
Locations:
city: Greenville
country: United States
facility: East Carolina University
state: North Carolina
Study officials:
affiliation: Assistant Professor, East Carolina University
name: Swati M Surkar, PT, PhD
role: PRINCIPAL_INVESTIGATOR
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