Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-24 @ 6:31 PM
NCT ID:
NCT04209257
Eligibility Criteria:
Inclusion Criteria:
* Age 10-18
* Spastic CP (di-, tetra-, or triplegia)
* Levels I-II GMFCS classification
* Sufficient covering of the femoral head in the acetabulum (migration % \< 40)
* Mild crouch gait (minimum knee flexion 21-40o during stance)
* Potential to gain \> 20 degrees knee extension improvement in stance phase
* Minimum of 0o ankle dorsiflexion passive range of motion (PROM)
* 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 lower extremity
* Lower extremity surgery or fractures in the past year
* Botox injections to Lower extremity in the past 6 months
* Implanted medical device contraindicated with application of FES
* Severe spasticity in Lower extremity (Mod Ashworth 4)
* Lower extremity joint pain during walking
* Hx of pulmonary disease limiting exercise tolerance or Hx of cardiac disease
* Severely limited range of motion / contractures (\>15o knee flex or \>15o hip flex contractures)
* Pregnancy
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
10 Years
Maximum Age:
18 Years
Study:
NCT04209257
Study Brief:
Protocol Section:
NCT04209257