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

• ClinicalTrials.gov Identifier: NCT00295295
• Recruitment Status: Completed
• First Posted: February 23, 2006
• Last Update Posted: June 20, 2013
• Sponsor: Children's Hospital Los Angeles
• Collaborator: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
• Information provided by: Children's Hospital Los Angeles

Tracking Information

• First Submitted Date: February 21, 2006
• First Posted Date: February 23, 2006
• Last Update Posted Date: June 20, 2013
• Study Start Date: September 2004
• Primary Completion Date: Not Provided

Current Primary Outcome Measures (submitted: December 14, 2007)

• Vertebral bone density [ Time Frame: Measured at Month 12 ]
• Tibia bone density [ Time Frame: Measured at Month 12 ]
• Tibia cross-sectional area [ Time Frame: Measured at Month 12 ]

Original Primary Outcome Measures (submitted: February 21, 2006)

• Vertebral bone density
• Tibia bone density
• Tibia cross-sectional area

Current Secondary Outcome Measures (submitted: June 5, 2013)

• Calf muscle strength [ Time Frame: Measured at Month 12 ]
• Balance test [ Time Frame: Measured at Month 12 ]
  Clinical balance test used by California Children's Services, Los Angeles County Medical Therapy Units

Original Secondary Outcome Measures (submitted: February 21, 2006)

• Calf muscle strength
• Balance test

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Vibration Intervention to Improve Bone and Muscle in Children With Cerebral Palsy
• Official Title: Mechanical Intervention in Children With Cerebral Palsy
• 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.

• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Cerebral Palsy

Intervention

• 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

Study Arms

• 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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Enrollment (submitted: February 21, 2006): 34
• Original Enrollment: Same as current
• Actual Study Completion Date: September 2007
• Primary Completion Date: Not Provided

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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 6 Years to 12 Years (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00295295
• Other Study ID Numbers: 1R21AR051564( U.S. NIH Grant/Contract ); R21AR051564 ( U.S. NIH Grant/Contract ); 1R21AR051564 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Not Provided
• Study Sponsor: Children's Hospital Los Angeles
• Collaborators: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Investigators

• 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

• PRS Account: Children's Hospital Los Angeles
• Verification Date: May 2013