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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Children's Hospital Los Angeles
ClinicalTrials.gov Identifier:
NCT00295295
First received: February 21, 2006
Last updated: June 19, 2013
Last verified: May 2013

February 21, 2006
June 19, 2013
September 2004
Not Provided
  • Vertebral bone density [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ]
  • Tibia bone density [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ]
  • Tibia cross-sectional area [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ]
  • Vertebral bone density
  • tibia bone density
  • tibia cross-sectional area
Complete list of historical versions of study NCT00295295 on ClinicalTrials.gov Archive Site
  • Calf muscle strength [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ]
  • Balance test [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ]
    Clinical balance test used by California Children's Services, Los Angeles County Medical Therapy Units
  • Calf muscle strength
  • balance test
Not Provided
Not Provided
 
Vibration Intervention to Improve Bone and Muscle in Children With Cerebral Palsy
Mechanical Intervention in Children With Cerebral Palsy

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Cerebral Palsy
  • Device: High frequency, low magnitude vibration
    High frequency, low magnitude vibration at 30 Hz, 10 min/day using vibrating platform from Juvent Medical Inc.
  • Other: Standing
    Standing 10 min/day
  • Experimental: Vibration
    High frequency, low magnitude vibration at 30 Hz, 10 min/day using vibrating platform from Juvent Medical Inc.
    Intervention: Device: High frequency, low magnitude vibration
  • Active Comparator: Standing
    Standing 10 min/day
    Intervention: Other: Standing
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
34
September 2007
Not Provided

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)
Both
6 Years to 12 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00295295
1-R21-AR051564, R21AR051564, 1-R21-AR051564
Not Provided
Not Provided
Children's Hospital Los Angeles
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Principal Investigator: Tishya A.L. Wren, PhD 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
Children's Hospital Los Angeles
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP