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

Not Applicable

• Conditions: Gait Disorders, Neurologic; Locomotion Disorder, Neurologic; CP
• Interventions: Other: Whole body vibration training

• Registration Number: NCT04961749
• Lead Sponsor: University of Texas, El Paso

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-17
• Study First Submitted: 2021-06-23
• Status Verified: 2021-07
• Study First Submitted QC: 2021-07-02
• Last Update Submitted: 2021-07-02
• Study First Posted: 2021-07-14
• Last Update Posted: 2021-07-14
• Primary Completion: 2022-06-16
• Study Completion: 2022-06-16

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vibration group	Whole body vibration training	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

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The University of Texas at El Paso; 🇺🇸 El Paso, Texas, United States