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.

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy
• Intervention / Treatment: Device: High frequency, low magnitude vibration; Other: Standing

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
• Enrollment: 34
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90027
      • Children's Hospital Los Angeles

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 12 years (Child)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Vertebral bone density	Measured at Month 12
Tibia bone density	Measured at Month 12
Tibia cross-sectional area	Measured at Month 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Calf muscle strength		Measured at Month 12
Balance test	Clinical balance test used by California Children's Services, Los Angeles County Medical Therapy Units	Measured at Month 12

Collaborators and Investigators

• 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

Study record dates

Study Major Dates

• Study Start: September 1, 2004
• Study Completion (Actual): September 1, 2007

Study Registration Dates

• First Submitted: February 21, 2006
• First Submitted That Met QC Criteria: February 21, 2006
• First Posted (Estimated): February 23, 2006

Study Record Updates

• Last Update Posted (Actual): January 10, 2024
• Last Update Submitted That Met QC Criteria: January 8, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: bone density; vibration
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: 1R21AR051564 (U.S. NIH Grant/Contract); R21AR051564 (U.S. NIH Grant/Contract)