The Effects of Electrical Stimulation Gait Training on Walking and Posture for Children With Cerebral Palsy

Cerebral Palsy Clinical Trial

Official title: Electrical Stimulation Gait Training to Effect Improvements in Walking Function and Posture for Children With Cerebral Palsy

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

This is a single blinded, randomized, controlled pre-test/post-test study design (Figure 4). The twenty children with spastic diplegia or hemiplegia CP will be randomized by a statistician to one of two treatment groups. One group will undergo a 12-week at-home gait training program with ES, subjects/guardians can choose either the surface or percutaneous stimulation subgroup, and the second group will undergo a 12-week at-home gait training program without ES. For both groups, data will be collected at five points: just before gait training, after 4 and 8 weeks of gait training, at the conclusion of gait training (after 12 weeks), and 4 weeks after gait training has been discontinued (16 weeks post initiation of gait training). Data collection at each follow-up point will include the kinetics and kinematics of walking, standing posture, gait initiation, plantar pressures, the administration of the Timed Up & Go and Functional Reach Test, and the assessment of lower extremity muscle strength using a hand-held dynamometer. The Canadian Occupational Performance Measure (COPM) will be applied before and after the 12-week gait training program and 4 weeks after the gait training has been discontinued. For the 20 children with typical development, the same data will be collected (except for the COPM) and used for comparison to the pre-training data collected from all 20 children with CP. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Palsy

• NCT number: NCT00292786
• Study type: Interventional
• Source: Shriners Hospitals for Children
• Status: Completed
• Phase: N/A
• Start date: June 2005
• Completion date: January 2008