Effects of Treadmill Training and Whole-body Vibration in Children With Cerebral Palsy

Cerebral Palsy Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04630392
• Other study ID #: H19180
• Status: Recruiting
• Phase: N/A
• Start date: November 12, 2018
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Georgia State University
• Contact: Jianhua Wu, PhD
• Phone: 404-413-8476
• Email: jwu11[@]gsu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Other:
• Treadmill Training
Ten minutes of treadmill walking at 110% self-selected overground walking speed
• Whole Body Vibration & Treadmill Training
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.

Locations

Country	Name	City	State
United States	Georgia State University	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Georgia State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overground gait walking speed	Measured in m/s from kinematic motion capture data	immediately after intervention
Primary	Overground gait step length	Measured in cm from kinematic motion capture data	immediately after intervention
Primary	Overground gait dynamic knee range of motion	Measured in degrees from kinematic motion capture data	immediately after intervention
Primary	Overground gait dynamic ankle range of motion	Measured in degrees from kinematic motion capture data	immediately after intervention
Primary	Overground gait muscle activity as measured by electromyographic sensors	integrated area per gait cycle at the following muscles: biceps femoris, vastus lateralis, lateral gastrocnemius, tibialis anterior	immediately after intervention
Primary	Lower extremity spasticity as measured by the Modified Tardieu Test	including R1 and R2 joint angles as well as qualitative score	immediately after intervention