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

NCT04630392 | Recruiting

• 1 other identifier: H19180
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Outcome Measures

Primary Outcomes (6)

• Overground gait walking speed

  Measured in m/s from kinematic motion capture data

  immediately after intervention

• Overground gait step length

  Measured in cm from kinematic motion capture data

  immediately after intervention

• Overground gait dynamic knee range of motion

  Measured in degrees from kinematic motion capture data

  immediately after intervention

• Overground gait dynamic ankle range of motion

  Measured in degrees from kinematic motion capture data

  immediately after intervention

• 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

• Lower extremity spasticity as measured by the Modified Tardieu Test

  including R1 and R2 joint angles as well as qualitative score

  immediately after intervention

Study Arms (1)

Intervention Group

EXPERIMENTAL

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

Other: Treadmill Training; Other: Whole Body Vibration & Treadmill Training

Interventions

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.

Intervention Group

Treadmill Training OTHER

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

Intervention Group

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Georgia State University: lead

Study Sites (1)

Georgia State University

Atlanta, Georgia, 30303, United States

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Jianhua Wu, PhD

  Georgia State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianhua Wu, PhD

CONTACT

404-413-8476; jwu11@gsu.edu

Gena Priest, PT, DPT, PhD

CONTACT

404-413-1221; gpriest@gsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Self-controlled study

Study Record Dates

• First Submitted: September 25, 2020
• First Posted: November 16, 2020
• Study Start: November 12, 2018
• Primary Completion (Estimated): November 20, 2026
• Study Completion (Estimated): November 20, 2026
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)