Retention of Whole-body Training Effects on Ambulatory Function in Children With Cerebral Palsy (CP_WBVT)

This study will evaluate the retention effects of a four-week whole-body vibration training intervention in children with Cerebral Palsy. The primary outcomes for this study are gait function, including Timed Up and Go and the two-minute walk test. Secondary outcomes of this study include lower extremity gait function, coordination, and gait variability. For this study, a total of 10 children with Cerebral Palsy (CP) will be recruited with 5 being randomly placed into an experimental group and 5 being randomly placed into a control group. Each participant, regardless of group, will complete pre-, post-, and retention testing, with a four-week whole-body vibration training intervention between the pre- and post-testing. The four-week whole-body vibration training will include three visits per week, with the experimental group receiving a vibration stimulus while standing on a vibration platform. Vibration sessions will consist of three-minutes of vibration, followed by three minutes rest, completing this cycle three separate times. The control group will follow a similar pattern, but rather than experiencing vibration, they will hear a sound of the vibration platform through a speaker. Once the four-week training session is finished, participants will return after a three-month retention period to determine whether ambulation function was retained.

Study Overview

• Status: Completed
• Conditions: Gait Disorders, Neurologic; CP; Locomotion Disorder, Neurologic
• Intervention / Treatment: Other: Whole body vibration training

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • El Paso, Texas, United States, 79968
      • The University of Texas at El Paso

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 12 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosis of Cerebral Palsy
• Ability to walk independently

Exclusion Criteria:

• Musculoskeletal injuries or conditions (other than Cerebral Palsy) which alter their independent walking ability

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vibration group; This group will receive vibration stimulation while standing on a side-alternating vibration platform. Vibration sessions will occur three times per week over four-weeks. Each session will include three-minutes of vibration followed by three-minutes rest, completing this sequence three times per session	Other: Whole body vibration training; Whole-body vibration training applies a vibration stimulus to an individual as they are standing on a side-alternating platform. The vibration creates small muscle contractions in the lower extremity musculature which has been shown to improve function and ambulatory function.
No Intervention: Control group; This group will not receive vibration, but will rather hear a recording of the vibration, while still standing on the vibration platform. Still, this group will receive this training three times per week over four-weeks with a similar three-minute rotation as the vibration group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Timed up and go test	Amount of time to quickly and safely complete the test	16 weeks
Two-minute walk test	Distance covered while walking for two minutes	16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lower extremity gait function	Three-dimensional motion capture will be used to track lower extremity segment movement patterns. All measurements will have units of degrees	16 weeks

Collaborators and Investigators

• Sponsor: University of Texas, El Paso
• Investigators: Principal Investigator: Jeffrey D Eggleston, PhD, The University of Texas at El Paso

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2021
• Primary Completion (Actual): June 21, 2023
• Study Completion (Actual): June 21, 2023

Study Registration Dates

• First Submitted: June 23, 2021
• First Submitted That Met QC Criteria: July 2, 2021
• First Posted (Actual): July 14, 2021

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Cerebral Palsy; Pediatrics; Locomotion
• Additional Relevant MeSH Terms: Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Cerebral Palsy; Gait Disorders, Neurologic
• Other Study ID Numbers: 1745950-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No