FES to Improve Crouch Gait in CP (CP FES Walking)

Shriners Hospitals for Children

Status: Completed

Conditions: Cerebral Palsy; Gait

Treatments: Device: Functional Electrical Stimulation.

Study type: Interventional

Funder types: Other

Identifiers

NCT04209257

71011-PHI

Details and patient eligibility

About

The overall goal of the proposed work is to develop and to assess the feasibility of using functional electrical stimulation (FES) system to improve crouch gait in individuals with cerebral palsy that may prevent the typical downward spiral of walking function decline in individuals with CP that occurs from adolescence into adulthood.

Full description

Aim 1: To assess the feasibility of using a multiple channel FES system to produce an immediate neuroprosthetic effect to reduce crouch gait in children and adolescents with spastic diplegic CP.

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.

Enrollment: 13 patients

Sex: All

Ages: 10 to 18 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age 10-18
• 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

• Athetoid, ataxic, or hemiplegic CP
• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 1 patient group

Functional Electrical Stimulation protocol

Experimental group

Description:

Participants will be evaluated with and without the use of functional electrical stimulation while walking to determine the neuroprosthetic and neurotherapeutic effects.

Treatment:

Device: Functional Electrical Stimulation.