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

Primary Purpose

CP, Gait Disorders, Neurologic, Locomotion Disorder, Neurologic

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Whole body vibration training
Sponsored by
University of Texas, El Paso
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for CP focused on measuring Cerebral Palsy, Locomotion, Pediatrics

Eligibility Criteria

8 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The University of Texas at El PasoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Vibration group

Control group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 23, 2021
Last Updated
July 2, 2021
Sponsor
University of Texas, El Paso
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1. Study Identification

Unique Protocol Identification Number
NCT04961749
Brief Title
Retention of Whole-body Training Effects on Ambulatory Function in Children With Cerebral Palsy
Acronym
CP_WBVT
Official Title
Retention of Whole-body Training Effects on Ambulatory Function in Children With Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 17, 2021 (Actual)
Primary Completion Date
June 16, 2022 (Anticipated)
Study Completion Date
June 16, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas, El Paso

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
CP, Gait Disorders, Neurologic, Locomotion Disorder, Neurologic
Keywords
Cerebral Palsy, Locomotion, Pediatrics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vibration group
Arm Type
Experimental
Arm Description
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
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Whole body vibration training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Timed up and go test
Description
Amount of time to quickly and safely complete the test
Time Frame
16 weeks
Title
Two-minute walk test
Description
Distance covered while walking for two minutes
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Lower extremity gait function
Description
Three-dimensional motion capture will be used to track lower extremity segment movement patterns. All measurements will have units of degrees
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeffrey D Eggleston, PhD
Phone
915-747-6012
Email
jdeggleston@utep.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey D Eggleston, PhD
Organizational Affiliation
The University of Texas at El Paso
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas at El Paso
City
El Paso
State/Province
Texas
ZIP/Postal Code
79968
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeffrey D Eggleston, PhD
Phone
915-747-6012
Email
jdeggleston@utep.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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