CP FES WalkingFunctional Electrical Stimulation (FES) to Improve Gait in CP Short Title
Functional Electrical Stimulation protocol
+ Treadmill only protocol
Brain Damage, Chronic+2
+ Brain Diseases
+ Central Nervous System Diseases
Treatment Study
Summary
Study start date: October 24, 2019
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.2 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 10 to 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 2 locations
Shriner's Hospital for Children
Philadelphia, United States