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NCT Number: NCT04630392

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

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.

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Key information

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Treadmill training

Other

Ten minutes of treadmill walking at 110% self-selected overground walking speed

Whole Body Vibration & Treadmill Training

Other

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.

Primary outcomes

  1. Overground gait walking speed

    Time frame: immediately after intervention

    Measured in m/s from kinematic motion capture data

  2. Overground gait step length

    Time frame: immediately after intervention

    Measured in cm from kinematic motion capture data

  3. Overground gait dynamic knee range of motion

    Time frame: immediately after intervention

    Measured in degrees from kinematic motion capture data

  4. Overground gait dynamic ankle range of motion

    Time frame: immediately after intervention

    Measured in degrees from kinematic motion capture data

  5. 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

  6. Lower extremity spasticity as measured by the Modified Tardieu Test

    Time frame: immediately after intervention

    including R1 and R2 joint angles as well as qualitative score

Study contacts

Contact information is provided by the study sponsor or research team.

Gena Priest, PT, DPT, PhD

CONTACT

[email protected]

404-413-1221

Jianhua Wu, PhD

CONTACT

[email protected]

404-413-8476

Sponsors and collaborators

Lead sponsor

Georgia State University

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2026
Study completion
2026
First posted
Nov 16, 2020
Registry last updated
Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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