FES to Improve Crouch Gait in CP

Completed · Not applicable

Conditions studied: Cerebral Palsy, Gait

In brief

The overall goal of the proposed work is to develop and to assess the feasibility of using functional electrical stimulation (FES) system to improve crouch gait in individuals with cerebral palsy that may prevent the typical downward spiral of walking function decline in individuals with CP that occurs from adolescence into adulthood.

Key facts

Study ID

NCT04209257

Run by

Shriners Hospitals for Children

People needed

13

Starts

2012-01-01

Expected to finish

2016-12-01

Last updated by the study team

2019-12-30

Who can join

Age: 10 and older, up to 18. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

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 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

Where it is running

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

Full record on ClinicalTrials.gov

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