Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
13 participants
INTERVENTIONAL
2012-01-31
2016-12-31
Brief Summary
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Detailed Description
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Aim 2: To assess the feasibility of using a multiple channel FES system as a therapeutic training tool to produce lasting neurotherapeutic effects of diminished crouch gait in children and adolescents with CP.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Functional Electrical Stimulation protocol
Participants will be evaluated with and without the use of functional electrical stimulation while walking to determine the neuroprosthetic and neurotherapeutic effects.
Functional Electrical Stimulation.
Functional electrical stimulation - electrical stimulation applied to a muscle during an activity (i.e. ankle dorsiflexors during swing phase of gait). It assists / elicits muscle activation in order to achieve a task.
Interventions
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Functional Electrical Stimulation.
Functional electrical stimulation - electrical stimulation applied to a muscle during an activity (i.e. ankle dorsiflexors during swing phase of gait). It assists / elicits muscle activation in order to achieve a task.
Eligibility Criteria
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Inclusion Criteria
* Spastic CP (di-, tetra-, or triplegia)
* Levels I-II GMFCS classification
* Sufficient covering of the femoral head in the acetabulum (migration % \< 40)
* Mild crouch gait (minimum knee flexion 21-40o during stance)
* Potential to gain \> 20 degrees knee extension improvement in stance phase
* Minimum of 0o ankle dorsiflexion passive range of motion (PROM)
* Visual, perceptual, cognitive, and communication skills to follow multiple step commands for attending to exercise and data collection
* Seizure-free or well controlled seizures
Exclusion Criteria
* Significant scoliosis (primary curve \> 40°)
* Spinal fusions extending into the pelvis
* Severe tactile hypersensitivity
* Joint instability or dislocation in lower extremity
* Lower extremity surgery or fractures in the past year
* Botox injections to Lower extremity in the past 6 months
* Implanted medical device contraindicated with application of FES
* Severe spasticity in Lower extremity (Mod Ashworth 4)
* Lower extremity joint pain during walking
* Hx of pulmonary disease limiting exercise tolerance or Hx of cardiac disease
* Severely limited range of motion / contractures (\>15o knee flex or \>15o hip flex contractures)
* Pregnancy
10 Years
18 Years
ALL
Yes
Sponsors
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Shriners Hospitals for Children
OTHER
Responsible Party
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Samuel C.K. Lee, PhD, PT
Principal Investigator
Principal Investigators
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Samuel Lee, PT, PhD
Role: PRINCIPAL_INVESTIGATOR
Shriners Hospital for Children & University of Delaware
Locations
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Shriners Hospitals for Children, Philadelphia
Philadelphia, Pennsylvania, United States
Countries
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Related Links
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Dr. Lee's current research studies
Other Identifiers
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71011-PHI
Identifier Type: -
Identifier Source: org_study_id