Efficacy of New Protocols in the Treatment of Upper Limb Dysfunctions in Patients With Cerebral Palsy
- Conditions
- Cerebral Palsy
- Interventions
- Device: Low dosage SES groupProcedure: traditional rehabilitation programDevice: High dosage SES groupDevice: VRCIT groupDevice: VRCIT+SES group
- Registration Number
- NCT03048851
- Lead Sponsor
- Chang Gung Memorial Hospital
- Brief Summary
Immediate and maintaining Efficacy of new protocols in the treatment of upper limb dysfunctions in patients with cerebral palsy.
- Detailed Description
Cerebral palsy (CP) is the most common childhood motor disability. Spasticity and loss of dexterity are the major problems for motor disability of upper extremity (UE) in patients with CP. This study propose two novel treatment protocols: sensory electrical stimulation (SES) and virtual reality constraint-induced therapy (VRCIT) to improve function of UE in patients with CP. Investigators hypothesize that combined SES and VRCIT treatment have better effect than single therapy (SES or VRCIT).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 125
- Diagnosis with spastic CP with Gross Motor Function Classification System(GMFCS) levels I-IV
- Aged 2-24 years
- Ability to undergo clinical assessment
- Ability to comprehend commands and cooperate during an examination
- Chromosomal abnormalities
- Progressive neurological disorder or severe concurrent illness or disease not typically associated with CP
- Active medical conditions such as pneumonia or poor physical conditions that would interfere with participation
- Any major surgery or nerve block in the preceding 3 months
- Metabolic or hormonal disturbance
- Cardiovascular disorder
- Poor tolerance or a poor cooperation during assessment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Low dosage SES group Low dosage SES group Low dosage SES group received the low dosage SES training in addition to traditional rehabilitation. Each SES session involved electrical stimulation followed by UE training in addition to home program. traditional rehabilitation group traditional rehabilitation program Shame control group received the shame SES and traditional rehabilitation programs. High dosage SES group High dosage SES group High dosage SES group received the high dosage SES training in addition to traditional rehabilitation. Each SES session involved electrical stimulation followed by UE training in addition to home program. VRCIT group VRCIT group VRCIT group received the VRCIT training in addition to traditional rehabilitation.Each VRCIT session involved practice of functional tasks with the more affected UE followed by virtual-reality based eye-hand coordination tasks with the more affected UE for, in addition to home program, and restraint of the less affected UE for 1.5 hours per day. VRCIT+SES group VRCIT+SES group VRCIT+SES group received the VRCIT and SES training in addition to traditional rehabilitation.
- Primary Outcome Measures
Name Time Method change from baseline of muscle tone and basic motor abilities of the upper limb muscles in 12 and 24 weeks baseline, 12weeks, 24weeks Muscle tone of the upper limb muscles assessment by Modified Ashworth Scale and Myoton (© 2011 Myoton AS.). 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.
- Secondary Outcome Measures
Name Time Method change from baseline of quality of life in 12 and 24 weeks baseline, 12weeks, 24weeks 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.
change from baseline of activities of daily living (ADL) in 12 and 24 weeks baseline, 12weeks, 24weeks The ADL assessments included Functional Independence Measure for Children (WeeFIM) and Pediatric Motor Activity Log (PMAL). The measure is a composite.
change from baseline of bone mineral density in 12 and 24 weeks baseline, 12weeks, 24weeks he 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).
change from baseline of Metabolism and Body composition in 12 and 24 weeks baseline, 12weeks, 24weeks 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(InBody230). The measure is a composite.
change from baseline of severity in 12 and 24 weeks baseline, 12 weeks, 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.
change from baseline of kinematic analysis in 12 and 24 weeks baseline, 12weeks, 24weeks Kinematic analysis for patients performing Reach-to-grasp and Eye-hand coordination tasks.The measure is a composite.
change from baseline of muscle strength and endurance in 12 and 24 weeks baseline, 12 weeks, 24 weeks The device (Hoggan-5081) for kinetic analysis combined range of motion (ROM), muscle testing (MicroFET3) and grip and pinch gauge (MicroFET4) and data capture software, attached to a computer for more thorough testing. MicroFET4 combined pinch gauge and grip tester in a single device with high test-retest reliability. The Grip Test included Maximum Grip Test, 5 Position Grip Test, Rapid Exchange Grip Test, Hand Grip Fatigue Test. The Pinch Test included key Pinch, palmar Pinch, and tip pinch. MicroFET3 combined Muscle Tester and ROM Gauge. Peak force and average strength were obtained. The padded attachment that was fit in the palm of the hand allowed the administrators to provide direct resistance to movement of the extremity. For arm strength test, the examiner manually stabilized the body parts proximal to the tested limb segment during testing and asked participants to exert a maximal isometric muscle contraction lasting 3-seconds while the dynamometer was held stationary.
change from baseline of reaction-time in 12 and 24 weeks baseline, 12 weeks ,24 weeks To examine the reaction time by CANTAB® software.
Trial Locations
- Locations (1)
Chang Gung Memorial Hospital
🇨🇳Taoyuan, Taiwan