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Vibration Intervention to Improve Bone and Muscle in Children With Cerebral Palsy

Primary Purpose

Cerebral Palsy

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
High frequency, low magnitude vibration
Standing
Sponsored by
Children's Hospital Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring vibration, bone density

Eligibility Criteria

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

Inclusion Criteria: Diagnosis of cerebral palsy Low vertebral bone density Able to stand for 10 minutes with handheld support Parent or guardian willing to provide informed consent Exclusion Criteria: Surgery, casting, or receipt of botulinum toxin in the 12 months prior to study entry Planned surgery, casting, or receipt of botulinum toxin in the 12 months after study entry Metal rods or plates in tibia or lumbar spine Severe scoliosis (greater than 20 degrees) or bowing of tibia Medical condition other than cerebral palsy affecting bone or muscle Require corticosteroids or seizure medication (phenytoin)

Sites / Locations

  • Children's Hospital Los Angeles

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Vibration

Standing

Arm Description

High frequency, low magnitude vibration at 30 Hz, 10 min/day using vibrating platform from Juvent Medical Inc.

Standing 10 min/day

Outcomes

Primary Outcome Measures

Vertebral bone density
Tibia bone density
Tibia cross-sectional area

Secondary Outcome Measures

Calf muscle strength
Balance test
Clinical balance test used by California Children's Services, Los Angeles County Medical Therapy Units

Full Information

First Posted
February 21, 2006
Last Updated
June 19, 2013
Sponsor
Children's Hospital Los Angeles
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
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1. Study Identification

Unique Protocol Identification Number
NCT00295295
Brief Title
Vibration Intervention to Improve Bone and Muscle in Children With Cerebral Palsy
Official Title
Mechanical Intervention in Children With Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Children's Hospital Los Angeles
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

4. Oversight

5. Study Description

Brief Summary
Cerebral palsy is a group of disorders characterized by lack of coordination in the muscles, loss of movement, and speech disturbances. These disorders are caused by injuries to the brain that occur during fetal development or near the time of birth. The purpose of this study is to determine the effects of high frequency, low magnitude vibration on bone and muscle in children with cerebral palsy.
Detailed Description
The extent of bone mass built up during childhood and adolescence is the most important determinant of osteoporosis later in life. Some disabled children, such as those with cerebral palsy, are particularly vulnerable to low bone mass accumulation due to decreased mobility and weight-bearing. These children also have poor muscle strength and control, which limits function and contributes to the lack of mechanical stimulation needed to build bone mass. The most common treatment for these children is physical therapy, which is time- and labor-intensive and may not be adequately available to them. Whole body vibration has shown promise as an alternative method for stimulating increases in bone mass and improvements in muscle. The purpose of this study is to evaluate the effects of high frequency, low magnitude vibration on bone and muscle in children with cerebral palsy. This intervention may be useful as a noninvasive, nonpharmacological treatment for low bone mass and poor muscle function in these children. This study will last 1 year. All participants will visit the hospital 3 times, at study entry and Months 6 and 12. At each visit, height and weight will be measured, muscle strength and balance will be tested, and bones and muscles in the spine and lower leg will be imaged with computed tomography (CT), a special x-ray machine. Participants will be randomly assigned to one of two groups. For this study, all participants will be asked to stand for 10 minutes every day for 1 year. For Group 1, a vibrating platform will be used for the 10-minute standing sessions during the first half of the study but not during the second half of the study. For Group 2, this will be reversed and the vibrating platform will not be used during the first half of the study but will be used during the second half of the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
vibration, bone density

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (false)

8. Arms, Groups, and Interventions

Arm Title
Vibration
Arm Type
Experimental
Arm Description
High frequency, low magnitude vibration at 30 Hz, 10 min/day using vibrating platform from Juvent Medical Inc.
Arm Title
Standing
Arm Type
Active Comparator
Arm Description
Standing 10 min/day
Intervention Type
Device
Intervention Name(s)
High frequency, low magnitude vibration
Intervention Description
High frequency, low magnitude vibration at 30 Hz, 10 min/day using vibrating platform from Juvent Medical Inc.
Intervention Type
Other
Intervention Name(s)
Standing
Intervention Description
Standing 10 min/day
Primary Outcome Measure Information:
Title
Vertebral bone density
Time Frame
Measured at Month 12
Title
Tibia bone density
Time Frame
Measured at Month 12
Title
Tibia cross-sectional area
Time Frame
Measured at Month 12
Secondary Outcome Measure Information:
Title
Calf muscle strength
Time Frame
Measured at Month 12
Title
Balance test
Description
Clinical balance test used by California Children's Services, Los Angeles County Medical Therapy Units
Time Frame
Measured at Month 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of cerebral palsy Low vertebral bone density Able to stand for 10 minutes with handheld support Parent or guardian willing to provide informed consent Exclusion Criteria: Surgery, casting, or receipt of botulinum toxin in the 12 months prior to study entry Planned surgery, casting, or receipt of botulinum toxin in the 12 months after study entry Metal rods or plates in tibia or lumbar spine Severe scoliosis (greater than 20 degrees) or bowing of tibia Medical condition other than cerebral palsy affecting bone or muscle Require corticosteroids or seizure medication (phenytoin)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tishya A.L. Wren, PhD
Organizational Affiliation
Children's Orthopaedic Center, Children's Hospital Los Angeles, and Departments of Orthopaedics and Radiology, Keck School of Medicine, Department of Biomedical Engineering, School of Engineering, University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States

12. IPD Sharing Statement

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Vibration Intervention to Improve Bone and Muscle in Children With Cerebral Palsy

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