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

NCT ID: NCT04630392

Last Updated: 2024-03-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-12
• Study Completion Date: 2024-12-31

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.

Conditions

Cerebral Palsy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention Group

There are two intervention groups: treadmill walking only, whole-body vibration plus treadmill walking.

Group Type: EXPERIMENTAL

Treadmill Training

Intervention Type: OTHER

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

Whole Body Vibration & Treadmill Training

Intervention Type: 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.

Interventions

Treadmill Training

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

Intervention Type: OTHER

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Georgia State University

OTHER

Sponsor Role: lead

Responsible Party

Jianhua Wu

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jianhua Wu, PhD

Role: PRINCIPAL_INVESTIGATOR

Georgia State University

Locations

Georgia State University

Atlanta, Georgia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jianhua Wu, PhD

Role: CONTACT

jwu11@gsu.edu

404-413-8476

Gena Henderson, PT, DPT, PhD

Role: CONTACT

ghenderson2@gsu.edu

404-413-1221

Facility Contacts

Jianhua Wu, PhD

Role: primary

jwu11@gsu.edu

404-413-8476

Gena Henderson, PT, DPT, PhD

Role: backup

ghenderson2@gsu.edu

404-413-1221

Other Identifiers

H19180

Identifier Type: -

Identifier Source: org_study_id