Ignite Creation Date:
2025-12-24 @ 3:50 PM
Ignite Modification Date:
2025-12-26 @ 4:11 PM
Study NCT ID:
NCT04630392
Status:
RECRUITING
Last Update Posted:
2024-03-29
First Post:
2020-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Treadmill Training and Whole-body Vibration in Children With Cerebral Palsy
Sponsor:
Georgia State University
Organization:
Study Overview
Official Title:
Effects of the Addition of a Single Bout of Whole-Body Vibration to a Single Bout of Treadmill Training on Gait and Spasticity in Ambulatory Children With Cerebral Palsy
Status:
RECRUITING
Status Verified Date:
2024-03
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:
Whole-body vibration (WBV) and treadmill training (TT) are commonly-utilized rehabilitation interventions for children with neuromotor disorders. WBV has been shown in the literature to positively affect gait and lower body spasticity in this population. However, the effects of a single session of WBV are generally transient, lasting between ten minutes and two hours. Thus, it may be necessary to combine WBV with another intervention to reinforce improved movement patterns and maximize its potential benefits. Therefore, the aim of this study is to investigate the effects of the addition of a single bout of WBV to a single bout of TT on the lower extremity spasticity and gait parameters of ambulatory children with CP.
Detailed Description:
Whole-body vibration (WBV) and treadmill training (TT) are commonly-utilized rehabilitation interventions for children with neuromotor disorders. The evidence supporting the use of TT in children with cerebral palsy (CP) remains inconclusive, but WBV has been shown in the literature to positively affect gait and lower body spasticity in this population. However, the effects of a single session of WBV are generally transient, lasting between ten minutes and two hours. Thus, it may be necessary to combine WBV with another intervention to reinforce improved movement patterns and maximize its potential benefits. Therefore, the aim of this study is to investigate the effects of the addition of a single bout of WBV to a single bout of TT on the lower extremity spasticity and gait parameters of ambulatory children with CP.
The investigators plan to recruit 20 children between the ages of 6 and 17 with spastic CP. Subjects will complete a 10-minute bout of TT at 110% of their preferred overground (OG) walking speed, rest for 15 minutes, and then complete a 12-minute bout of WBV at 20Hz and 2mm followed by a second 10-minute bout of TT at the same speed. OG gait characteristics, including spatiotemporal parameters, joint kinematics, and electromyographic (EMG) parameters, will be collected at 5 time points: before the first bout of TT, immediately following the first bout of TT, before WBV, immediately following WBV, and immediately following the second bout of TT. Lower extremity spasticity will be assessed using multiple methods at the same time points. Changes in gait parameters and spasticity will be assessed using a one-way repeated measures ANOVA and a series of dependent t-tests. Significant level will be set at α = 0.05.
The investigators anticipate that acute improvements in OG gait parameters will be greater following the combined bout of WBV and TT than the bout of TT alone. The investigators expect this to be due to the reduction of lower extremity spasticity following WBV, which should allow for more normalized gait patterns during TT and improve carryover to OG gait. Further, the investigators expect to gain insight into the mechanisms responsible for spasticity reduction following WBV which will allow for the making of informed decisions regarding clinical rehabilitative protocols involving WBV and TT.
The investigators plan to recruit 20 children between the ages of 6 and 17 with spastic CP. Subjects will complete a 10-minute bout of TT at 110% of their preferred overground (OG) walking speed, rest for 15 minutes, and then complete a 12-minute bout of WBV at 20Hz and 2mm followed by a second 10-minute bout of TT at the same speed. OG gait characteristics, including spatiotemporal parameters, joint kinematics, and electromyographic (EMG) parameters, will be collected at 5 time points: before the first bout of TT, immediately following the first bout of TT, before WBV, immediately following WBV, and immediately following the second bout of TT. Lower extremity spasticity will be assessed using multiple methods at the same time points. Changes in gait parameters and spasticity will be assessed using a one-way repeated measures ANOVA and a series of dependent t-tests. Significant level will be set at α = 0.05.
The investigators anticipate that acute improvements in OG gait parameters will be greater following the combined bout of WBV and TT than the bout of TT alone. The investigators expect this to be due to the reduction of lower extremity spasticity following WBV, which should allow for more normalized gait patterns during TT and improve carryover to OG gait. Further, the investigators expect to gain insight into the mechanisms responsible for spasticity reduction following WBV which will allow for the making of informed decisions regarding clinical rehabilitative protocols involving WBV and TT.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: