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

Gait Disorders, Neurologic Clinical Trial

— CP_WBVT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04961749
• Other study ID #: 1745950-2
• Status: Recruiting
• Phase: N/A
• Start date: June 17, 2021
• Est. completion date: June 16, 2022

Study information

• Verified date: July 2021
• Source: University of Texas, El Paso
• Contact: Jeffrey D Eggleston, PhD
• Phone: 915-747-6012
• Email: jdeggleston[@]utep.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: June 16, 2022
• Est. primary completion date: June 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• CP
• Disease
• Gait Disorders, Neurologic
• Locomotion Disorder, Neurologic
• Nervous System Diseases

Intervention

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.

Locations

Country	Name	City	State
United States	The University of Texas at El Paso	El Paso	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas, El Paso

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Timed up and go test	Amount of time to quickly and safely complete the test	16 weeks
Primary	Two-minute walk test	Distance covered while walking for two minutes	16 weeks
Secondary	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