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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
  Purpose

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.


Condition Intervention Phase
Cerebral Palsy
Device: High frequency, low magnitude vibration
Other: Standing
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Mechanical Intervention in Children With Cerebral Palsy

Resource links provided by NLM:


Further study details as provided by Children's Hospital Los Angeles:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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


Estimated Enrollment: 34
Study Start Date: September 2004
Study Completion Date: September 2007
Arms Assigned Interventions
Experimental: Vibration
High frequency, low magnitude vibration at 30 Hz, 10 min/day using vibrating platform from Juvent Medical Inc.
Device: High frequency, low magnitude vibration
High frequency, low magnitude vibration at 30 Hz, 10 min/day using vibrating platform from Juvent Medical Inc.
Active Comparator: Standing
Standing 10 min/day
Other: Standing
Standing 10 min/day

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.

  Eligibility

Ages Eligible for Study:   6 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00295295

Locations
United States, California
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
Sponsors and Collaborators
Children's Hospital Los Angeles
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00295295     History of Changes
Other Study ID Numbers: 1-R21-AR051564, R21AR051564, 1-R21-AR051564
Study First Received: February 21, 2006
Last Updated: June 19, 2013
Health Authority: United States: Federal Government

Keywords provided by Children's Hospital Los Angeles:
vibration
bone density

Additional relevant MeSH terms:
Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on November 27, 2014