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Completed

NCT Number: NCT04598711

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

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).

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

6 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

East Carolina University

Greenville, North Carolina, 27834, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

RLIC

Behavioral

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.

Other names: Remote Limb Ischemic Conditioning

Sham conditioning

Behavioral

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.

Other names: Sham

Muscle Power training

Behavioral

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.

Other names: Quadriceps power training

Balance training

Behavioral

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.

Other names: Dynamic Stability Platform Training

Treadmill training

Behavioral

All participants will undergo short burst interval treadmill training using self-selected and fast walking speeds.

Other names: Gait training

Primary outcomes

  1. Change in Peak knee extension power

    Time frame: Pre-intervention to 1 month post-intervention follow-up

    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).

  2. Change in Balance Score

    Time frame: Pre-intervention to 1 month post-intervention follow-up

    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.

  3. Change in Walking Speed

    Time frame: Pre-intervention to 1 month post-intervention follow-up

    Self-selected and fast walking speeds will be measured using 10-meter walk test.

Secondary outcomes

  1. Quadriceps Electromyography

    Time frame: Pre-intervention to 1 month post-intervention follow-up

    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.

  2. Gait Analysis

    Time frame: Pre-intervention to 1 month post-intervention follow-up

    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.

  3. Lower limb activity

    Time frame: Pre-intervention to 1 month post-intervention follow-up

    Lower extremity activity will be measured using accelerometers (Actigraphs) worn on bilateral ankles for 24 hours. Specific accelerometry variable will be number of steps.

Sponsors and collaborators

Lead sponsor

East Carolina University

Other

Registry information

Official study title

Effects of Remote Limb Ischemic Conditioning to Enhance Muscle Power, Dynamic Balance, and Walking Performance in Children With Cerebral Palsy

Acronym: I-C-FUN

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 22, 2020
Registry last updated
Mar 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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