Status:
COMPLETED
FES Assisted Cycling in Children With CP
Lead Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsors:
Shriners Hospitals for Children
Conditions:
Cerebral Palsy Spastic Diplegia
Eligibility:
All Genders
10-18 years
Phase:
NA
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 an...
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 m...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2016
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT04688424
Start Date
April 1 2008
End Date
June 30 2016
Last Update
December 30 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Shriners Hospitals fof Children, Philadelphia
Philadelphia, Pennsylvania, United States, 19140