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

NCT04961749 | Completed

• 1 other identifier: 1745950-2
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

CP; Gait Disorders, Neurologic; Locomotion Disorder, Neurologic

Keywords

Cerebral Palsy; Locomotion; Pediatrics

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Lower extremity gait function

  16 weeks

Study Arms (2)

Vibration group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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.

Interventions

Whole body vibration training OTHER

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.

Vibration group

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Diagnosis of Cerebral Palsy
• Ability to walk independently

You may not qualify if:

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

Sponsors & Collaborators

• University of Texas, El Paso: lead

Study Sites (1)

The University of Texas at El Paso

El Paso, Texas, 79968, United States

Location

MeSH Terms

Conditions

Gait Disorders, Neurologic; Cerebral Palsy

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases

Study Officials

• Jeffrey D Eggleston, PhD

  The University of Texas at El Paso

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 23, 2021
• First Posted: July 14, 2021
• Study Start: June 17, 2021
• Primary Completion: June 21, 2023
• Study Completion: June 21, 2023
• Last Updated: April 28, 2026

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)