FES Assisted Cycling in Children With CP (CP FES Cycling)

United States Department of Health and Human Services (HHS)

Status: Completed

Conditions: Cerebral Palsy Spastic Diplegia

Treatments: Device: FES; Other: Cycling

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04688424

5R01HD062588-02

Details and patient eligibility

About

This project proposes to assess if Functional Electrical Stimulation (FES) assisted cycling can improve the cycling ability, muscle strength, cardiovascular health, quality of life, self perception and functional mobility of adolescents with CP better than a volitional cycling program or a non-intervention control group.

Full description

Aim 1: To compare the effects of 8-weeks of FES-assisted cycling training on improving cardiorespiratory fitness, walking function, self-motivated exercise/recreation, self-perception and functional mobility and quality of life of adolescents with spastic CP with marginal walking ability (Gross Motor Function Classification System Levels II - IV) vs. 8-weeks of volitional cycling training and a non-intervention control group.

Aim 2: To compare the effects of 8-weeks FES-assisted cycling training on changes in cycling ability of adolescents with spastic CP with marginal walking ability vs. 8-weeks of volitional cycling training and a nonintervention control group.

Aim 3: To elucidate the mechanisms for potential improvements in cycling ability after 8-weeks of FES-assisted or volitional cycling training of adolescents with spastic CP and marginal walking ability.

Enrollment: 39 patients

Sex: All

Ages: 10 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Spastic CP (di-, tetra-, or triplegic)
• Level II, III or IV GMFCS classification
• Sufficient covering of the femoral head in the acetabulum (migration % < 40)
• Adequate range of motion of the hips, knees and ankles to allow pedaling
• 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 LE
• LE surgery or fractures in the past year
• Botox injections to LE in the past 6 months
• Severe spasticity in LE (Mod Ashworth 4)
• LE joint pain during cycling
• Hx of pulmonary disease limiting exercise tolerance or Hx of cardiac disease
• Severely limited ROM / contractures that prevent the subject from being able to be safely positioned on the cycle
• Pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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39 participants in 3 patient groups

FES + Cycling

Experimental group

Description:

Functional electrical stimulation cycling group

Treatment:

Other: Cycling

Device: FES

Cycling only

Active Comparator group

Description:

Volitional cycling group (no electrical stimulation)

Treatment:

Other: Cycling

Control

No Intervention group

Description:

control group