Ignite Creation Date:
2024-05-05 @ 4:40 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00292786
Status:
COMPLETED
Last Update Posted:
2008-02-05
First Post:
2006-02-15
Brief Title:
The Effects of Electrical Stimulation Gait Training on Walking and Posture for Children With Cerebral Palsy
Sponsor:
Shriners Hospitals for Children
Organization:
Shriners Hospitals for Children
Study Overview
Official Title:
Electrical Stimulation Gait Training to Effect Improvements in Walking Function and Posture for Children With Cerebral Palsy
Status:
COMPLETED
Status Verified Date:
2008-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
This is a single blinded randomized controlled pre-testpost-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 subjectsguardians 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 4365 | None | None | None |