FES to Improve Gait in CP

Stopped early · Not applicable

Conditions studied: Cerebral Palsy, Spastic Diplegia Cerebral Palsy, Gait

In brief

The goal of this proposal is to mitigate the typical decline in walking function experienced by children with cerebral palsy (CP) via a Functional Electrical Stimulation (FES)-assisted treadmill training intervention. In this study, the investigators intend to use thier CP FES Gait Training System to assess the neurotherapeutic effects of an FES-assisted treadmill training intervention on walking performance in children with CP. The research design consists of a randomized, controlled, two-treatment study in which the control subjects will cross-over into one of the two treatment groups. An FES-assisted training group will undergo twelve weeks of FES-assisted treadmill training using a distributive practice protocol consisting of alternating bouts of walking with and without FES assistance, followed by over ground walking reinforcement. A treadmill-only training group will undergo the same training regimen without FES-assistance. Finally, a non-intervention group will serve as a control. The investigators will analyze treatment efficacy via functional and biomechanical and measures collected pre-training, post-training and after a twelve-week follow-up period.

Key facts

Study ID

NCT04591288

Run by

Shriners Hospitals for Children

People needed

2

Starts

2019-10-24

Expected to finish

2019-12-31

Last updated by the study team

2020-10-19

Who can join

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

You may qualify if…

• Age 10-18
• Diagnosis of spastic diplegic CP
• Gross Motor Functional Classification Scale (GMFCS) level I-III
• Hip migration < 40%
• Displays crouch, equinus, or jump type gait
• At least 0° passive dorsiflexion range of motion (can come to a neutral position)
• Sufficient visuoperceptual, cognitive and communication skills
• Seizure-free or well-controlled seizures
• No other neurological or musculoskeletal disorders (e.g. dystonia, severe scoliosis, hip instability)
• Ability to travel to University of Delaware or Shriners Hospital for children multiple times per week for training and assessment
• Ability to communicate pain or discomfort
• Ability to consent (if 18 years old) or obtain parent/guardian consent (if under 18)

You may not qualify if…

• Diagnosis of athetoid or ataxic CP
• Scoliosis with primary curve > 49%
• Spinal fusions extending into pelvis
• Lower Extremity (LE) joint instability or dislocation
• Severe tactile hypersensitivity
• LE botulinum (Botox) injections in the past 6 mo.
• Implanted medical device contraindicative of FES
• Pregnancy
• Severe LE spasticity (Modified Ashworth Scale score of 4 or greater)
• History of pulmonary disease limiting exercise tolerance (Asthma Control screen)
• History of cardiac disease (AHA screen)
• Excessive LE joint pain during walking
• Severely limited joint range of motion / irreversible muscle contractures, i.e.> 10°knee flexion, >15° hip flexion contractures, or >5° plantarflexion contractures
• LE surgery or significant injury within 1 yr.

Where it is running

• University of Delaware — Newark, Delaware, United States
• Shriner's Hospital for Children — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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