- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04630392
Effects of Treadmill Training and Whole-body Vibration in Children With Cerebral Palsy
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jianhua Wu, PhD
- Phone Number: 404-413-8476
- Email: jwu11@gsu.edu
Study Contact Backup
- Name: Gena Henderson, PT, DPT, PhD
- Phone Number: 404-413-1221
- Email: ghenderson2@gsu.edu
Study Locations
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Georgia
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Atlanta, Georgia, United States, 30303
- Recruiting
- Georgia State University
-
Contact:
- Jianhua Wu, PhD
- Phone Number: 404-413-8476
- Email: jwu11@gsu.edu
-
Contact:
- Gena Henderson, PT, DPT, PhD
- Phone Number: 404-413-1221
- Email: ghenderson2@gsu.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- a medical diagnosis of spastic CP
- a GMFCS level of I, II, or III
- age of 6-17 years at the time of data collection
Exclusion Criteria:
- history of musculoskeletal injury within the past 3 months
- history of Botox injections to the lower extremities within the past 3 months
- history of significant cardiac abnormalities and/or uncontrolled seizures
- any cognitive or behavioral issues that prevent the subject from safely following instructions while walking on the treadmill
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention Group
There are two intervention groups: treadmill walking only, whole-body vibration plus treadmill walking.
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Ten minutes of treadmill walking at 110% self-selected overground walking speed
Eight bouts of 90 seconds of vibration at 20 Hz and an amplitude of 2 mm on a Galileo Med-L side-to-side-alternating WBV plate (StimDesigns LLC, Carmel, CA, USA) followed by ten minutes of treadmill walking at 110% self selected overground walking speed.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overground gait walking speed
Time Frame: immediately after intervention
|
Measured in m/s from kinematic motion capture data
|
immediately after intervention
|
Overground gait step length
Time Frame: immediately after intervention
|
Measured in cm from kinematic motion capture data
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immediately after intervention
|
Overground gait dynamic knee range of motion
Time Frame: immediately after intervention
|
Measured in degrees from kinematic motion capture data
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immediately after intervention
|
Overground gait dynamic ankle range of motion
Time Frame: immediately after intervention
|
Measured in degrees from kinematic motion capture data
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immediately after intervention
|
Overground gait muscle activity as measured by electromyographic sensors
Time Frame: immediately after intervention
|
integrated area per gait cycle at the following muscles: biceps femoris, vastus lateralis, lateral gastrocnemius, tibialis anterior
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immediately after intervention
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Lower extremity spasticity as measured by the Modified Tardieu Test
Time Frame: immediately after intervention
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including R1 and R2 joint angles as well as qualitative score
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immediately after intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jianhua Wu, PhD, Georgia State University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H19180
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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