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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
24
See descriptions under arm/group descriptions. RLIC is delivered for 14 visits. Visits 1-3 occur on consecutive work days and visits 4-14 occur on alternating week days.
See descriptions under arm/group descriptions. Sham conditioning is delivered for 14 visits. Visits 1-3 occur on consecutive work days and visits 4-14 occur on alternating week days.
All participants undergo power training of the quadriceps muscles using unilateral and bilateral leg presses (Total Gym GTS, San Diego, CA), 3 times/week for 4 consecutive weeks (12 sessions). Power training will follow standard American College of Sports Medicine guidelines for frequency, intensity, progression etc. Power training is provided at visits 3-14.
East Carolina University
Greenville, North Carolina, United States
Change in Peak knee extension power
Power is defined as the ability to exert a maximum force in short amount of time (speed) while performing knee extension. Bilateral quadriceps power will be measured using Humac Norm Isokinetic testing device (Computer Sports Medicine Inc, Stoughton, MA).
Time frame: Pre-intervention to 1 month post-intervention follow-up
Change in Balance Score
The average amount of time in seconds that a participant maintains the stability platform within ±5° of horizontal position during 15 trials of 30 seconds each. The total score will range between 0-30 seconds. Higher balance score indicates better balance performance.
Time frame: Pre-intervention to 1 month post-intervention follow-up
Change in Walking Speed
Self-selected and fast walking speeds will be measured using 10-meter walk test.
Time frame: Pre-intervention to 1 month post-intervention follow-up
Quadriceps Electromyography
While performing the isokinetic power testing, the electromyography (EMG) data will be recorded simultaneously. The EMG data will be used to quantify the electrical amplitude of quadriceps muscle.
Time frame: Pre-intervention to 1 month post-intervention follow-up
Gait Analysis
Lower extremity walking kinematics and kinetics will be measured using 10-camera motion analysis system (Qualisys Inc., Gothenburg, Sweden). Specific kinematic variables are hip, knee, and ankle joint torques. Kinetic variables are peak hip, knee, and ankle sagittal plane joint moments.
Time frame: Pre-intervention to 1 month post-intervention follow-up
Lower limb activity
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All participants undergo training on a balance board, learning to hold the board level with equal weight on each leg. Participants perform the balance task for 15, 30-second trials per day at visits 3-14.
All participants will undergo short burst interval treadmill training using self-selected and fast walking speeds.
Lower extremity activity will be measured using accelerometers (Actigraphs) worn on bilateral ankles for 24 hours. Specific accelerometry variable will be number of steps.
Time frame: Pre-intervention to 1 month post-intervention follow-up