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

March 10, 2023 updated by: Swati Manoharrao Surkar, East Carolina University

Effects of Remote Limb Ischemic Conditioning to Enhance Muscle Power, Dynamic Balance, and Walking Performance 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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • North Carolina
      • Greenville, North Carolina, United States, 27834
        • East Carolina University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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 Names:
  • Dynamic Stability Platform Training
Behavioral: Treadmill Training
All participants will undergo short burst interval treadmill training using self-selected and fast walking speeds.
Other Names:
  • 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: 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 Names:
  • 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 Names:
  • Dynamic Stability Platform Training
Behavioral: Treadmill Training
All participants will undergo short burst interval treadmill training using self-selected and fast walking speeds.
Other Names:
  • Gait 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 Names:
  • Sham

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Pre-intervention to 1 month post-intervention follow-up
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.
Pre-intervention to 1 month post-intervention follow-up
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.
Pre-intervention to 1 month post-intervention follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Pre-intervention to 1 month post-intervention follow-up
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.
Pre-intervention to 1 month post-intervention follow-up
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.
Pre-intervention to 1 month post-intervention follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

East Carolina University

Investigators

  • Principal Investigator: Swati M Surkar, PT, PhD, Assistant Professor, East Carolina University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2021

Primary Completion (Actual)

December 30, 2022

Study Completion (Actual)

December 30, 2022

Study Registration Dates

First Submitted

October 1, 2020

First Submitted That Met QC Criteria

October 16, 2020

First Posted (Actual)

October 22, 2020

Study Record Updates

Last Update Posted (Actual)

March 13, 2023

Last Update Submitted That Met QC Criteria

March 10, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-003232

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

IPD Sharing Time Frame

Data will be available soon after the completion of the study.

IPD Sharing Access Criteria

Contact Dr. Surkar

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cerebral Palsy

Clinical Trials on RLIC

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tunisia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe