NCT04591288

FES to Improve Gait in CP

Functional Electrical Stimulation (FES) to Improve Gait in CP Short Title

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Shriners Hospitals for Children · Academic / Other
• Sex: All
• Age: 10 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Aim 1: Assess the neurotherapeutic effects of FES-assisted treadmill and treadmill-only training on walking function relative to each other and to the control group. 1.1 The FES-assisted treadmill and treadmill-only groups will demonstrate greater improvements in walking speed and walking distance than the control group post-training and at follow-up. The FES-assisted treadmill group will show greater improvements than the treadmill-only group. 1.2 The FES-assisted treadmill and treadmill-only groups will demonstrate greater improvement in walking energy efficiency than the control group post-training and at follow-up. The FES-assisted treadmill group will show greater improvement than the treadmill-only group. 1.3 The FES-assisted treadmill and treadmill-only groups will demonstrate greater improvements in GMFM, perceived functional mobility, quality of life and self-perception measures than the control group post-training and at follow-up. The FES-assisted treadmill group will show greater improvements than the treadmill-only group. Aim 2: Assess the differential neurotherapeutic effects of FES-assisted treadmill and treadmill-only training on walking biomechanics. The investigators will measure these effects using instrumented motion capture. 2.1 The FES-assisted treadmill group will demonstrate greater improvements in gait kinematics in stance phase (higher peak hip and knee extension and lower peak ankle dorsiflexion) and swing phase (higher peak knee extension and larger knee excursion) than the treadmill only and non-intervention groups 2.2 The FES-assisted treadmill group will demonstrate greater improvements in lower extremity kinetics (lower hip and knee extensor moments and increased ankle plantarflexion power) than the treadmill only and non- intervention groups. 2.3 The FES-assisted treadmill group will demonstrate greater improvements in spatiotemporal gait parameters (increased step length and gait velocity, decreased step width and double support time) than the treadmill- only and control groups. Aim 3: Identify predictive measures of training efficacy. 3.1 Pre-training walking speed and energy efficiency will correlate with improvements in walking performance measures of Aim 1. 3.2 Increased neuroprosthetic correction of gait biomechanics measures achieved by FES will be positively correlated with walking performance measures of Aim 1.

Conditions

• Cerebral Palsy
• Spastic Diplegia Cerebral Palsy
• Gait

Interventions

Type	Name	Description
OTHER	Functional Electrical Stimulation protocol	FES-assisted treadmill walking followed by a 12-week follow-up period. Subjects will train three times a week walking at a target speed corresponding to 60-80% of their age-predicted maximum heart rate. Each training session will consist of five six-minute walking bouts, with five-minute rest periods between bouts. Each treadmill bout consists of alternating one- minute intervals of FES on and FES off. For the last walking bout, the first three minutes will be FES-assisted on the treadmill and the last three minutes will be overground walking without FES assistance to promote carryover effects. Total walking time is 30 minutes and the entire training session lasts approximately 50 minutes.
OTHER	Treadmill only protocol	We will implement a 12-wk Treadmill training protocol consisting of treadmill walking followed by a 12-week follow-up period. Subjects will train three times a week walking at a target speed corresponding to 60-80% of their age. Each training session will consist of five six-minute walking bouts, with five-minute rest periods between bouts. Total walking time is 30 minutes and the entire training session lasts approximately 50 minutes.

Timeline

• Start date: 2019-10-24
• Primary completion: 2019-12-31
• Completion: 2019-12-31
• First posted: 2020-10-19
• Last updated: 2020-10-19

Locations

2 sites across 1 country: United States