- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00292786
The Effects of Electrical Stimulation Gait Training on Walking and Posture for Children With Cerebral Palsy
Electrical Stimulation Gait Training to Effect Improvements in Walking Function and Posture for Children With Cerebral Palsy
This proposal is designed to achieve the following specific aims and will test the associated hypotheses:
AIM 1: To compare walking ability, standing posture, gait initiation and functional standing and stepping of twenty children with typical development to that of twenty children with spastic diplegia or hemiplegia, CP.
Hypotheses
- Children with CP will demonstrate impaired coordination as compared to children of typical development. In addition, children with CP will demonstrate inappropriate foot contact area, decreased velocity and step length as compared to children of typical development.
- Children with CP will demonstrate impaired postural control as compared to children of typical development.
- Children with CP will demonstrate an impaired gait initiation motor program as compared to children with typical development.
- Children with CP will take more time to complete the timed up and go test and demonstrate decreased reaching distances in the functional reach test as compared to children of typical development.
AIM 2: Using a single-blinded, randomized, controlled study design, to assess the ability of a 12-week at-home electrical stimulation gait training program to improve walking ability, standing posture, gait initiation, functional standing and stepping, and satisfaction with walking ability for a group of 10 children with spastic diplegia or hemiplegia CP as compared to a group of 10 children with spastic diplegia or hemiplegia CP who undergo a 12-week at-home gait training program without electrical stimulation.
Hypotheses
- The ES gait training group will demonstrate improved joint coordination as compared to the group undergoing a gait training program without ES. The ES gait training group will demonstrate improved foot contact area, increased self-selected walking velocity and greater step length as compared to the group undergoing a gait training program without ES.
- The ES gait training group will demonstrate improved postural control as compared to the group undergoing a gait training program without ES.
- The ES gait training group will demonstrate improved gait initiation as compared to the gait training group without ES.
- The ES gait training group will demonstrate decreased times on the Timed Up and Go and an increase in functional reach as compared to the group undergoing a gait training program without ES.
- The ES gait training group will demonstrate greater satisfaction and self-perceived performance on everyday tasks related to walking function and posture as measured by the COPM compared to the group that undergoes a gait training program without ES.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19140
- Shriners Hospital for Children Philadelphia
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- A diagnosis of spastic diplegia or spastic hemiplegia or a history of typically development for the measurement only group.
- A Level I, II or III gross motor function classification.
- The subject classified as Level I or II is able to walk indoors and outdoors and climb stairs holding onto a railing but experiences limitations walking in crowds or confined spaces. Subjects classified as Level III's need to walk with assistive devices and have limitations in their ability to ambulate outdoors and in the community. Children have at best only minimal ability to perform gross motor skills such as running and jumping.
- Male or female between the ages of 7 and 14 years of age.
- Family able and willing to provide adequate care to electrodes and electrode sites.
- Must be orthopedically cleared without imminent risk of hip subluxation or dislocation and no significant scoliosis.
- Seizure-free.
- Visuoperceptual skills and cognitive/communication skills sufficient to follow multiple step commands and to attend to tasks associated with data collection.
- Absence of severe tactile hypersensitivity in the lower extremities.
- Willingness to stay in Philadelphia for extended period of time to train and return for follow-up data.
- Written, informed consent.
- One year post soft tissue releases to the lower extremities.
- Passive range of motion of lower extremity joints: <10 degrees contracture of hip in extension as measured by the Thomas Test; <5 degrees knee flexion contracture and popliteal angle <45 degrees; at least 0 degrees of ankle dorsiflexion with knee extended and foot in varus.
Exclusion Criteria:
- Children with "mixed" types of CP (ie:Athetosis) or other movement disorders (ie:Ataxia).
- Allergy or sensitivity to non-latex tape placed in the skin
- Female children cannot be pregnant. A pregnancy test will be given if it is possible that the child can become pregnant, to ascertain whether or not the child is pregnant.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Gait Kinematics, Spatial Temporal Parameters &Interjoint coordination, Standing Center of Pressure Variables, Canadian Occupational Performance Measurement, Muscle activation and timing, Timed up and go test, Functional Reach test
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: James J McCarthy, MD, Shriners Hospital for Children Philadelphia
- Study Director: Carole A Tucker, PhD, PT, Shriners Hospital Philadelphia
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 8520
- 4365
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cerebral Palsy
-
Gazi UniversityCompletedCerebral Palsy | Cerebral Palsy, Spastic | Cerebral Palsy Spastic Diplegia | Cerebral Palsy Quadriplegic | Cerebral Palsy, MonoplegicTurkey
-
St Mary's University CollegeUniversity of GloucestershireUnknownCerebral Palsy | Cerebral Palsy Ataxic | Cerebral Palsy, MixedUnited Kingdom
-
Northwestern UniversityActive, not recruitingCerebral Palsy | Diplegic Cerebral Palsy | Bilateral Cerebral PalsyUnited States
-
Centre Médico-Chirurgical de Réadaptation des Massues...RecruitingCerebral Palsy, Dyskinetic | Cerebral Palsy, Spastic | Infantile Hemiplegic Cerebral PalsyFrance
-
Hilde FeysHasselt University; ETH Zurich; Curtin UniversityRecruitingHemiplegic Cerebral Palsy | Cerebral Palsy, SpasticBelgium
-
University of California, San FranciscoNational Institutes of Health (NIH)RecruitingDystonic Cerebral Palsy | Dyskinetic Cerebral PalsyUnited States
-
MTI UniversityEnrolling by invitationSpastic Diplegic Cerebral PalsyEgypt
-
East Carolina UniversityRecruitingHemiplegic Cerebral Palsy | Unilateral Cerebral Palsy | Remote Ischemic ConditioningUnited States
-
October 6 UniversityCompletedSpastic Cerebral Palsy | Spastic Hemiplegic Cerebral PalsyEgypt
-
Marmara UniversityUnknownCerebral Palsy, Spastic | Cerebral Palsy, Spastic, DiplegicTurkey
Clinical Trials on Walking Practice with Functional Electrical Stimulation
-
Emory UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedCerebrovascular AccidentUnited States
-
Emory UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development...Recruiting
-
National Rehabilitation Center, Seoul, KoreaUnknown
-
National Yang Ming UniversityCompleted
-
Amit SethiNeuroelectrics Corporation; Zynex Medical Inc.Completed
-
Thomas Jefferson UniversityTemple University; University of Delaware; The Craig H. Neilsen Foundation; Magee...CompletedSpinal Cord InjuryUnited States
-
University of Sao PauloSuspended
-
Prof. Dr. Antônio Marcos Vargas da SilvaCompleted
-
University Health Network, TorontoCompleted
-
Chung Shan Medical UniversityCompleted