Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04961749
Other study ID # 1745950-2
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
See also
  Status Clinical Trial Phase
Completed NCT03593512 - Deep Brain Stimulation for Autonomic and Gait Symptoms in Multiple System Atrophy N/A
Completed NCT04117737 - A Pilot Study of Virtual Reality and Antigravity Treadmill for Gait Improvement in Parkinson N/A
Recruiting NCT04265482 - Community-based Cohort of Functional Decline in Subjective Cognitive Complaint Elderly
Completed NCT03192046 - Bracing for Walking in Parkinson's Disease N/A
Terminated NCT01678547 - Robot Walking Rehabilitation in Stroke Patients N/A
Recruiting NCT05510739 - Support for Physical Activity in Everyday Life With Parkinson's Disease N/A
Recruiting NCT05417399 - Influence of Hawthorne Effect and Dual-tasks on Gait in CP
Completed NCT05683925 - Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Gait Characteristics in Parkinson's Disease N/A
Recruiting NCT05801874 - Gait and Posture Analysis in Hemiparetic Patients Through Optoelectronic Systems, "Smart" Tools and Clinical Evaluation
Recruiting NCT05110053 - Spinal Cord sTimulation thEraPy for Parkinson's Disease Patients With Gait Problems Phase 1
Recruiting NCT04137146 - SNS for Treatment of PD Gait Disorder N/A
Terminated NCT05622786 - Effect of High-Intensity Gait Training Using a Treadmill on Locomotion Recovery in Traumatic Brain Injury Patients N/A
Recruiting NCT04855825 - Investigating the Effects of Wearable Robotic Exoskeleton for Improving Mobility and Cognition in Persons With MS N/A
Recruiting NCT05022147 - Enhancing Gait Using Alternating-Frequency DBS in Parkinson Disease Phase 1
Completed NCT04266743 - FeetMe® Monitor: Alternative for the Evaluation of Gait Speed After Stroke N/A
Completed NCT04622657 - Validity Reliability of The Dubousset Functional Test in Parkinson Disease N/A
Completed NCT02356536 - The Effect of a Wearable Cueing Device on Freezing of Gait in Parkinson's Disease Phase 1
Completed NCT00914095 - Study of Methylphenidate to Treat Gait Disorders And Attention Deficit In Parkinson's Disease (PARKGAIT-II) Phase 4
Completed NCT01108029 - Study of Memantine for Gait Disorders And Attention Deficit In Parkinson's Disease Phase 4
Completed NCT03314610 - Effect of Need to Void on Parkinsonian Gait