Ischemic Conditioning to Enhance Function (I-C-FUN) in Children With Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional

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.
    

Intervention name(s): RLIC; Sham Conditioning; Muscle Power training; Balance training; Treadmill Training
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): 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.; 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.
Other intervention name(s): Remote Limb Ischemic Conditioning; Sham; Quadriceps power training; Dynamic Stability Platform Training; Gait training
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double blinded, randomized controlled trial
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment