Clinical trial NCT04688424: FES Assisted Cycling in Children With CP
Official title: Functional Electrical Stimulation Assisted Cycling to Improve Fitness and Strength in Children With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy Spastic Diplegia
Keywords: Cerebral Palsy
Functional electrical stimulation
Cycling
Lead sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sponsor class: NIH
Collaborators: name: Shriners Hospitals for Children
First posted: 2020-12-30
Enrollment: 39
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in cycling Ability
timeFrame: Outcome assessed: Pre Training (week 0), Mid Training (week 4), Post Training (week 8), Follow-Up (week 16)
measure: Change in Energy Expenditure
timeFrame: Outcome assessed: Pre Training (week 0), Mid Training (week 4), Post Training (week 8), Follow-Up (week 16)
measure: Change in Gait speed
timeFrame: Outcome assessed: Before Training (week 0), Mid Training (week 4), After Training (week 8), Follow-Up (week 16)
measure: Change in Spatiotemporal gait parameter
timeFrame: Outcome assessed: Before Training (week 0), Mid Training (week 4), After Training (week 8), Follow-Up (week 16)
measure: Change in Muscle Strength
timeFrame: Outcome assessed: Before Training (week 0), Mid Training (week 4), After Training (week 8), Follow-Up (week 16)
measure: Change in Walking Distance
timeFrame: Outcome assessed: Before Training (week 0), Mid Training (week 4), After Training (week 8), Follow-Up (week 16)
measure: Change in Timed Up-And-Go
timeFrame: Outcome assessed: Before Training (week 0), Mid Training (week 4), After Training (week 8), Follow-Up (week 16)
measure: Change in Pedometer measurement
timeFrame: Outcome assessed: Before Training (week 0), Mid Training (week 4), After Training (week 8), Follow-Up (week 16)
measure: Change in Electromyography
timeFrame: Outcome assessed: Before Training (week 0), Mid Training (week 4), After Training (week 8), Follow-Up (week 16)
measure: Change in Self-Assessment
timeFrame: Outcome assessed: Before Training (week 0), Mid Training (week 4), After Training (week 8), Follow-Up (week 16)
measure: Change in Health related Quality of Life
timeFrame: Outcome assessed: Before Training (week 0), Mid Training (week 4), After Training (week 8), Follow-Up (week 16)
measure: Change in Self-Perception
timeFrame: Outcome assessed: Before Training (week 0), Mid Training (week 4), After Training (week 8), Follow-Up (week 16)
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Shriners Hospitals fof Children, Philadelphia
state: Pennsylvania
Study officials:
affiliation: Physical Therapy Department, University of Delaware
name: Samuel Lee, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: