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Completed

NCT Number: NCT00295295

Vibration Intervention to Improve Bone and Muscle 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.

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Key information

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

High frequency, low magnitude vibration

Device

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

Standing

Other

Standing 10 min/day

Primary outcomes

  1. Vertebral bone density

    Time frame: Measured at Month 12

  2. Tibia bone density

    Time frame: Measured at Month 12

  3. Tibia cross-sectional area

    Time frame: Measured at Month 12

Secondary outcomes

  1. Calf muscle strength

    Time frame: Measured at Month 12

  2. Balance test

    Time frame: Measured at Month 12

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

Sponsors and collaborators

Lead sponsor

Children's Hospital Los Angeles

Other

Collaborators

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Registry information

Official study title

Mechanical Intervention in Children With Cerebral Palsy

Important dates

Study start
2004
Study completion
2007
First posted
Feb 23, 2006
Registry last updated
Jan 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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