Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
39 participants
INTERVENTIONAL
2008-04-30
2016-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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FES + Cycling
Functional electrical stimulation cycling group
FES
FES will be applied via surface electrodes placed over bilateral quadriceps muscles. FES-stimulation will be ramped from sensory level (the level at which the individual feels a cutaneous sensation from the stimulation) to the maximum-tolerated level using a closed loop system controlled by computer software Subjects will exercise at home, three times per week, with FES on for 8 weeks with a goal of attaining 30 minutes of continuous cycling per session. If the individuals are unable to cycle for 30 continuous minutes, rest breaks will be provided with a goal of cycling for a total of 30 minutes. The length of each session will be approximately 45 minutes, with 15 minutes of set-up and 30 minutes of cycling.
Cycling
Subjects will exercise at home, three times per week, without FES for 8 weeks with a goal of attaining 30 minutes of continuous cycling per session. If the individuals are unable to cycle for 30 continuous minutes, rest breaks will be provided with a goal of cycling for a total of 30 minutes. The length of each session will be approximately 45 minutes, with 15 minutes of set-up and 30 minutes of cycling.
Cycling only
Volitional cycling group (no electrical stimulation)
Cycling
Subjects will exercise at home, three times per week, without FES for 8 weeks with a goal of attaining 30 minutes of continuous cycling per session. If the individuals are unable to cycle for 30 continuous minutes, rest breaks will be provided with a goal of cycling for a total of 30 minutes. The length of each session will be approximately 45 minutes, with 15 minutes of set-up and 30 minutes of cycling.
Control
control group
No interventions assigned to this group
Interventions
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FES
FES will be applied via surface electrodes placed over bilateral quadriceps muscles. FES-stimulation will be ramped from sensory level (the level at which the individual feels a cutaneous sensation from the stimulation) to the maximum-tolerated level using a closed loop system controlled by computer software Subjects will exercise at home, three times per week, with FES on for 8 weeks with a goal of attaining 30 minutes of continuous cycling per session. If the individuals are unable to cycle for 30 continuous minutes, rest breaks will be provided with a goal of cycling for a total of 30 minutes. The length of each session will be approximately 45 minutes, with 15 minutes of set-up and 30 minutes of cycling.
Cycling
Subjects will exercise at home, three times per week, without FES for 8 weeks with a goal of attaining 30 minutes of continuous cycling per session. If the individuals are unable to cycle for 30 continuous minutes, rest breaks will be provided with a goal of cycling for a total of 30 minutes. The length of each session will be approximately 45 minutes, with 15 minutes of set-up and 30 minutes of cycling.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
10 Years
18 Years
ALL
No
Sponsors
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Shriners Hospitals for Children
OTHER
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Responsible Party
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Samuel C.K. Lee, PhD, PT
Principal Investigator, Associate Professor, Dept of Physical Therapy
Principal Investigators
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Samuel Lee, PT, PhD
Role: PRINCIPAL_INVESTIGATOR
Physical Therapy Department, University of Delaware
Locations
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Shriners Hospitals fof Children, Philadelphia
Philadelphia, Pennsylvania, United States
Countries
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Related Links
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Dr. Lee's research studies
Other Identifiers
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