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

Cerebral Palsy Clinical Trial

Official title:

Mechanical Intervention in Children With Cerebral Palsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00295295
• Other study ID #: 1R21AR051564
• Secondary ID: R21AR0515641R21A
• Status: Completed
• Phase: Phase 2
• Start date: September 2004
• Est. completion date: September 2007

Study information

• Verified date: January 2024
• Source: Children's Hospital Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: September 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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)

Related Conditions & MeSH terms

• 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

Locations

Country	Name	City	State
United States	Children's Hospital Los Angeles	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital Los Angeles	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vertebral bone density		Measured at Month 12
Primary	Tibia bone density		Measured at Month 12
Primary	Tibia cross-sectional area		Measured at Month 12
Secondary	Calf muscle strength		Measured at Month 12
Secondary	Balance test	Clinical balance test used by California Children's Services, Los Angeles County Medical Therapy Units	Measured at Month 12