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

NCT ID: NCT04961749

Last Updated: 2021-07-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-17
• Study Completion Date: 2022-06-16

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

Whole body vibration training

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Texas, El Paso

OTHER

Sponsor Role: lead

Responsible Party

Jeffrey Eggleston

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jeffrey D Eggleston, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas at El Paso

Locations

The University of Texas at El Paso

El Paso, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jeffrey D Eggleston, PhD

Role: CONTACT

jdeggleston@utep.edu

915-747-6012

Facility Contacts

Jeffrey D Eggleston, PhD

Role: primary

jdeggleston@utep.edu

915-747-6012

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

1745950-2

Identifier Type: -

Identifier Source: org_study_id