Cerebral Palsy Clinical Trial
Official title:
The Relationship of Bone Strength and Fitness Training in Children With Cerebral Palsy
Verified date | May 2011 |
Source | Chang Gung Memorial Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Taiwan: Institutional Review Board |
Study type | Interventional |
In the first year, all subjects received clinical assessments include subjective assessment,
basic data, nutritional status and fitness assessments. Laboratory assessments include body
composition, bone density(lumbar spine and femur by dual energy X-ray absorptiometry ), bone
strength (by calcaneal ultrasound) and bone metabolism.
In the 2nd year, were randomized into three groups. The high level training group (20
children) will receive high frequency fitness training program(Frequency: three times one
week, Duration: thirty minutes). The low level training group (20 children) will receive low
frequency fitness training program(Frequency: two times one week, Duration: thirty
minutes).The control group (20 children) will not receive fitness training program but
maintain the usual life style.
In the 3rd year, all subjects received post-training clinical assessments include subjective
assessment, basic data, nutritional status and fitness assessments. Laboratory assessments
include body composition, bone density(lumbar spine and femur by dual energy X-ray
absorptiometry ), bone strength (by calcaneal ultrasound) and bone metabolism.
These data provided in this study could establish the bone quality and fitness data of
children with diplegic CP, and provide us to plan treatment strategies in the management of
bone and fitness problems in the future.
Status | Completed |
Enrollment | 60 |
Est. completion date | July 2009 |
Est. primary completion date | July 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 3 Years to 18 Years |
Eligibility |
Inclusion Criteria: - Aged 3-18 years - Good cognition to comprehend the command - Good cooperation during examination and fitness training Exclusion Criteria: - children with recognized chromosomal abnormalities - Active medical conditions such as pneumonia or others - Poor tolerance during assessment and fitness training |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Taiwan | Chang Gung Memorial Hospital | Taoyuan |
Lead Sponsor | Collaborator |
---|---|
Chang Gung Memorial Hospital | National Science Council, Taiwan |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Bone mineral Density Measurements | BMD in the lumbar spine and hip are measured with DXA. Standard scanning procedures were used for the lumbar spine. BMD measurements (g/cm2) were converted to age- and gender-normalized standard deviation scores (z scores). | 12 and 24 weeks | No |
Secondary | Children's Health Status | Children's Health Status Questionnaire | 12 and 24 weeks | No |
Secondary | quality of life | Cerebral Palsy Quality of Life Questionnaire | 12 and 24 weeks | No |
Secondary | Body composition | Body composition, lean body mass and body fat are measured | 12 and 24 weeks | No |
Secondary | Muscle strength | Hand grasp assessment by the hand dynamometer Abdominal muscle strength by curling up | 12 and 24 weeks | No |
Secondary | Flexibility | Forward bending distance during sitting position | 12 and 24 weeks | No |
Secondary | Cardiopulmonary function | Measurement of times when performing stepping forward and backward for 1 minute. The changes of heart rate and blood pressure before and after stepping | 12 and 24 weeks | No |
Secondary | Bone strength | Calcaneal bone strength BUA | 12 and 24 weeks | No |
Secondary | Bone metabolism | Serum calcium, Phosphate,Serum intact parathyroid hormone (iPTH),Serum total alkaline phosphatase (ALP),Urine deoxypyridinoline(D-Pyr) | 12 and 24 weeks | No |
Secondary | Motor function | BOTMP, GMFM | 12 and 24 weeks | No |
Secondary | Muscle strength | isokinetic torque of knee flexor and extensor at different angular velocities | 12 and 24 weeks | No |
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