Ischemic Conditioning to Enhance Function (I-C-FUN) in Children With Cerebral Palsy

University of North Carolina System

Status: Completed

Conditions: Cerebral Palsy

Treatments: Behavioral: Balance training; Behavioral: Sham Conditioning; Behavioral: RLIC; Behavioral: Treadmill Training; Behavioral: Muscle Power training

Study type: Interventional

Funder types: Other

Identifiers

NCT04598711

19-003232

Details and patient eligibility

About

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).

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 6 to 16 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 2 patient groups

Remote Limb Ischemic Conditioning (RLIC)

Experimental group

Description:

RLIC is achieved via blood pressure cuff inflation to at least 20 mmHg above systolic blood pressure to 200 mmHg on the more involved thigh. RLIC involves 5 cycles of 5 minutes blood pressure cuff inflation followed by alternating 5 minutes of cuff deflation and requires 45 minutes. RLIC is performed on visits 1-14. Interventions: * Behavioral: RLIC * Behavioral: Muscle power training * Behavioral: Balance training * Behavioral: Treadmill training

Treatment:

Behavioral: Muscle Power training

Behavioral: Treadmill Training

Behavioral: RLIC

Behavioral: Balance training

Sham Conditioning

Sham Comparator group

Description:

Sham conditioning is achieved via blood pressure cuff inflation to 25 mmHg on the more involved thigh. Sham involves 5 cycles of 5 minutes blood pressure cuff inflation followed by alternating 5 minutes of cuff deflation and requires 45 minutes. Sham conditioning is performed on visits 1-14. Interventions: * Behavioral: RLIC * Behavioral: Muscle power training * Behavioral: Balance training * Behavioral: Treadmill training

Treatment:

Behavioral: Muscle Power training

Behavioral: Treadmill Training

Behavioral: Sham Conditioning

Behavioral: Balance training