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Clinical Trials/NCT04598711
NCT04598711
Completed
Not Applicable

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

East Carolina University1 site in 1 country24 target enrollmentJune 15, 2021
ConditionsCerebral Palsy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cerebral Palsy
Sponsor
East Carolina University
Enrollment
24
Locations
1
Primary Endpoint
Change in Peak knee extension power
Status
Completed
Last Updated
3 years ago

Overview

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).

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.

Registry
clinicaltrials.gov
Start Date
June 15, 2021
End Date
December 30, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Swati Manoharrao Surkar

Assistant Professor

East Carolina University

Eligibility Criteria

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

Outcomes

Primary Outcomes

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).

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.

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

  • Quadriceps Electromyography(Pre-intervention to 1 month post-intervention follow-up)
  • Gait Analysis(Pre-intervention to 1 month post-intervention follow-up)
  • Lower limb activity(Pre-intervention to 1 month post-intervention follow-up)

Study Sites (1)

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