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

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ClinicalTrials.gov Identifier: NCT04598711
Recruitment Status : Recruiting
First Posted : October 22, 2020
Last Update Posted : September 29, 2021
Sponsor:
Information provided by (Responsible Party):
Swati Manoharrao Surkar, East Carolina University

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).

Condition or disease Intervention/treatment Phase
Cerebral Palsy Behavioral: RLIC Behavioral: Sham Conditioning Behavioral: Muscle Power training Behavioral: Balance training Behavioral: Treadmill Training Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double blinded, randomized controlled trial
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Participants are masked to group assignment (RLIC vs. Sham conditioning) and the assessor will be masked to group assignment of the participants.
Primary Purpose: Treatment
Official Title: Effects of Remote Limb Ischemic Conditioning to Enhance Muscle Power, Dynamic Balance, and Walking Performance in Children With Cerebral Palsy
Actual Study Start Date : June 15, 2021
Estimated Primary Completion Date : December 30, 2022
Estimated Study Completion Date : December 30, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Remote Limb Ischemic Conditioning (RLIC)

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
Behavioral: RLIC
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 Name: Remote Limb Ischemic Conditioning

Behavioral: Muscle Power training
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 Name: Quadriceps power training

Behavioral: Balance training
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 Name: Dynamic Stability Platform Training

Behavioral: Treadmill Training
All participants will undergo short burst interval treadmill training using self-selected and fast walking speeds.
Other Name: Gait training

Sham Comparator: Sham Conditioning

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
Behavioral: Sham Conditioning
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 Name: Sham

Behavioral: Muscle Power training
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 Name: Quadriceps power training

Behavioral: Balance training
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 Name: Dynamic Stability Platform Training

Behavioral: Treadmill Training
All participants will undergo short burst interval treadmill training using self-selected and fast walking speeds.
Other Name: Gait training




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04598711


Contacts
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Contact: Swati M Surkar 252-744-6244 surkars19@ecu.edu
Contact: John Willson 252-744-6241 willsonj@ecu.edu

Locations
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United States, North Carolina
East Carolina University Recruiting
Greenville, North Carolina, United States, 27834
Contact: Swati M. Surkar, PT, PhD    252-744-6244    surkars19@ecu.edu   
Contact: John Willson    252-744-6242    willsonj@ecu.edu   
Sponsors and Collaborators
East Carolina University
Investigators
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Principal Investigator: Swati M Surkar, PT, PhD Assistant Professor, East Carolina University
  Study Documents (Full-Text)

Documents provided by Swati Manoharrao Surkar, East Carolina University:
Informed Consent Form  [PDF] October 15, 2020

Publications:

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Responsible Party: Swati Manoharrao Surkar, Assistant Professor, East Carolina University
ClinicalTrials.gov Identifier: NCT04598711    
Other Study ID Numbers: 19-003232
First Posted: October 22, 2020    Key Record Dates
Last Update Posted: September 29, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: After completion of the study, all of the individual participant data after de-identification will be submitted to East Carolina University data repository.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Data will be available soon after the completion of the study.
Access Criteria: Contact Dr. Surkar

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cerebral Palsy
Nervous System Diseases
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases