Cerebral Palsy Clinical Trial
Official title:
Efficacy of New Protocols in the Treatment of Upper Limb Dysfunctions in Patients With Cerebral Palsy
NCT number | NCT02039284 |
Other study ID # | 101-5261A3 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 2013 |
Est. completion date | March 2018 |
Verified date | November 2017 |
Source | Chang Gung Memorial Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Cerebral palsy (CP) is the most common childhood motor disability. Weakness, spasticity, and loss of dexterity are the major problems in patients with CP. A novel virtual cycling training (VCT) program for lower limb was to enhance promising muscle strength through promoting the participant compliance and motivation. Sensory electrical stimulation(SES) of whole hand is a novel technique and is commonly used to treatment of spasticity for patients with stroke. Constraint-induced therapy (CIT) is a method for treating developmental disregard and learned non-use of affected limb and improving motor efficiency, functional performance, and activities of daily living for patients with CP.
Status | Completed |
Enrollment | 61 |
Est. completion date | March 2018 |
Est. primary completion date | January 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Years to 20 Years |
Eligibility |
Inclusion Criteria: 1. diagnosis with spastic CP with Gross Motor Function Classification System(GMFCS) levels I-IV 2. aged 3-20 years 3. ability to undergo clinical assessment 4. ability to comprehend commands and cooperate during an examination Exclusion Criteria: 1. chromosomal abnormalities 2. progressive neurological disorder or severe concurrent illness or disease not typically associated with CP 3. active medical conditions such as pneumonia or poor physical conditions that would interfere with participation 4. any major surgery or nerve block in the preceding 3 months 5. metabolic or hormonal disturbance 6. cardiovascular disorder 7. poor tolerance or a poor cooperation during assessment |
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 | change from baseline of muscle tone of the upper limb muscles in 12 and 24 weeks | muscle tone of the upper limb muscles assessment by Modified Ashworth Scale and Myoton( © 2011 Myoton AS.). | baseline, 12weeks, 24weeks | |
Primary | change from baseline of Basic motor abilities in 12 and 24 weeks | Basic motor abilities included the assessments of the Bruininks- Oseretsky Test of Motor Proficiency II (BOT II), Melbourne Assessment 2 (MA2), Quality of upper extremity skills test (QUEST). The measure is a composite. | baseline, 12 weeks, 24 weeks | |
Secondary | change from baseline of basic motor functions in 12 and 24 weeks | Basic motor functions included the assessments of the Beery-Buktenica Developmental Test of Visual-Motor Integration (VMI-Chinese), Test of Visual Perceptual Skills, third edition, (TVPS-3), Sensory profile (SP)-Chinese.The measure is a composite. | baseline, 12weeks, 24weeks | |
Secondary | change from baseline of quality of life in 12 and 24 weeks | The health-related quality of life(HRQOL) assess by Cerebral Palsy Quality of Life (CP QOL) for Child and adolescent. The CP QOL is a measure of HRQOL specific to children and adolescent with cerebral palsy. | baseline, 12weeks, 24weeks | |
Secondary | change from baseline of activities of daily living (ADL) in 12 and 24 weeks | The ADL assessments included Functional Independence Measure for Children (WeeFIM), Pediatric Motor Activity Log (PMAL), etc.. The measure is a composite. | baseline, 12weeks, 24weeks | |
Secondary | change from baseline of participation in 12 and 24 weeks | The assessments for participation included Assess of Preschool Children's Participation(APCP), Children Assessment of Participation and Enjoyment(CAPE) and Preferences for Activity of Children(PAC), and Adaptive Behavior Assessment System, second edition(ABAS-II)-Chinese, etc..The measure is a composite. | baseline, 12weeks, 24 weeks | |
Secondary | change from baseline of bone mineral density in 12 and 24 weeks | The areal bone mineral density (aBMD) (g/cm2) will be measured at the lumbar spine (L1 to L4) and the humerus of the more-affected limb using dual X-ray absorptiometry (DXA). | baseline, 12weeks, 24weeks | |
Secondary | change from baseline of Metabolism and Body composition in 12 and 24 weeks | The measure included the total energy expenditure (kcal/min), active energy expenditure (kcal/min), total number of steps, physical activity levels and duration, sleep duration and efficiency, weight, total body water, skeletal muscle mass (SMM), body fat mass (BFM), fat free mass, percent body fat, waist-hip ratio (WHR), and basal metabolic rate (BMR) by the devices of SenseWear(© 2013 BodyMedia, Inc.) and Body Composition Analyzer(InBody220). The measure is a composite. | baseline, 12weeks, 24weeks | |
Secondary | change from baseline of kinematic analysis in 12 and 24 weeks | Kinematic analysis for patients performing Reach-to-grasp and Eye-hand coordination tasks.The measure is a composite. | baseline, 12weeks, 24weeks | |
Secondary | change from baseline of muscle strength and endurance in 12 and 24 weeks | Measure muscle strength and endurance by the device which combines range of motion, muscle testing (MicroFET3) and grip and pinch gauge (MicroFET 4) and data capture software. | baseline, 12 weeks, 24 weeks | |
Secondary | change from baseline of severity in 12 and 24 weeks | The severity is evaluated by Gross Motor Function Classification System(GMFCS), Manual Ability Classification System (MACS).The assessments for body function included Modified Ashworth Scale (MAS), strength, endurance, and trunk and limb involvement, etc. The measure is a composite. | baseline, 12 weeks, 24 weeks | |
Secondary | change from baseline of reaction-time in 12 and 24 weeks | To examine the reaction time by CANTAB® software. | baseline, 12 weeks ,24 weeks |
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