FES Assisted Cycling in Children With CP

Completed · Not applicable

Conditions studied: Cerebral Palsy Spastic Diplegia

In brief

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.

Key facts

Study ID

NCT04688424

Run by

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

People needed

39

Starts

2008-04-01

Expected to finish

2016-06-30

Last updated by the study team

2020-12-30

Who can join

Age: 10 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Shriners Hospitals fof Children, Philadelphia — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.