- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03048851
Efficacy of New Protocols in the Treatment of Upper Limb Dysfunctions in Patients With Cerebral Palsy
May 27, 2020 updated by: Chang Gung Memorial Hospital
Immediate and Maintaining Efficacy of New Protocols in the Treatment of Upper Limb Dysfunctions in Patients With Cerebral Palsy
Immediate and maintaining Efficacy of new protocols in the treatment of upper limb dysfunctions in patients with cerebral palsy.
Study Overview
Status
Completed
Conditions
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).
Study Type
Interventional
Enrollment (Actual)
125
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Taoyuan, Taiwan, 333
- Chang Gung Memorial Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 24 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: traditional rehabilitation group
Shame control group received the shame SES and traditional rehabilitation programs.
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The participants were randomly assigned to one of the five intervention groups.
The absence of muscle contractions was controlled by the investigator the sham stimulation was carried out identically, but the stimulation amplitude was set to 0 milliampere(mA).
Subjects were not informed about the stimulation level and were instructed to distract attention from the stimulation.
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Experimental: 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.
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The participants were randomly assigned to one of the five intervention groups.
Low dosage SES group received the SES (Micro-Z Mini, Prizm Medical Inc., USA) training in addition to traditional rehabilitation.
Each SES session involved electrical stimulation followed by UE training in addition to home program.The novel SES programs were conducted twice per week, for 12 weeks.
Each SES session involved electrical stimulation followed by UE training in addition to home program.
The SES was applied to the forearm and whole hand with mesh glove (Electro-Mesh Glove-Sleeve Electrode Kit) for 45 minutes and arm with wrap for 45 minutes.
The pulse width was set to 300us for all stimulation levels.
The frequency was set to 100 Hz and 10 Hz.
Other Names:
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Experimental: 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.
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The participants were randomly assigned to one of the five intervention groups.
High dosage SES group received the SES (Micro-Z Mini, Prizm Medical Inc., USA) training in addition to traditional rehabilitation.
Each SES session involved electrical stimulation followed by UE training in addition to home program.The novel SES programs were conducted twice per week, for 12 weeks.
Each SES session involved electrical stimulation followed by UE training in addition to home program.
The SES was applied to the forearm and whole hand with mesh glove (Electro-Mesh Glove-Sleeve Electrode Kit) for 90 minutes and arm with wrap for 90 minutes.
The pulse width was set to 300us for all stimulation levels.
The frequency was set to 100 Hz and 10 Hz.
Other Names:
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Experimental: 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.
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The participants were randomly assigned to one of the five intervention groups.
VRCIT group received the VRCIT training plus traditional rehabilitation, conducted twice per week for 12 weeks.
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, plus home program, and restraint of the less affected UE for 1.5 hours per day.
The functional training of the more affected UE focused on massive practice of functional activities using the more affected arm, with the principles of shaping and repetitive task practice applied during training.
The VRCIT combined CIT and commercially available VR-based systems including Sony Playstation EyeToy and Nintendo Wii.
Other Names:
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Experimental: VRCIT+SES group
VRCIT+SES group received the VRCIT and SES training in addition to traditional rehabilitation.
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The participants were randomly assigned to one of the five intervention groups.
VRCIT+SES group executed VR programs by affected UE in Mesh-gloves (Electro-Mesh Glove-Sleeve Electrode Kit) with the optimal SES (Micro-Z Mini, Prizm Medical Inc., USA) protocol formulated from the 1st phase study.
The VRCIT program was conducted 1.5 hours/time, twice/week for 12 weeks.
The VRCIT combined CIT and commercially available VR-based systems.
Some commercially programs, such as Sony Playstation EyeToy (Sony Computer Entertainment America, Foster City, Calif., USA), and Nintendo Wii (Nintendo Domestic Distributor, College Point, N.Y., USA).
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change from baseline of muscle tone and basic motor abilities of the upper limb muscles in 12 and 24 weeks
Time Frame: baseline, 12weeks, 24weeks
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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.
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baseline, 12weeks, 24weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change from baseline of quality of life in 12 and 24 weeks
Time Frame: baseline, 12weeks, 24weeks
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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.
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baseline, 12weeks, 24weeks
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change from baseline of kinematic analysis in 12 and 24 weeks
Time Frame: baseline, 12weeks, 24weeks
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Kinematic analysis for patients performing Reach-to-grasp and Eye-hand coordination tasks.The measure is a composite.
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baseline, 12weeks, 24weeks
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change from baseline of severity in 12 and 24 weeks
Time Frame: baseline, 12 weeks, 24 weeks
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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.
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baseline, 12 weeks, 24 weeks
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change from baseline of reaction-time in 12 and 24 weeks
Time Frame: baseline, 12 weeks ,24 weeks
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To examine the reaction time by CANTAB® software.
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baseline, 12 weeks ,24 weeks
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change from baseline of activities of daily living (ADL) in 12 and 24 weeks
Time Frame: baseline, 12weeks, 24weeks
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The ADL assessments included Functional Independence Measure for Children (WeeFIM) and Pediatric Motor Activity Log (PMAL).
The measure is a composite.
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baseline, 12weeks, 24weeks
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change from baseline of bone mineral density in 12 and 24 weeks
Time Frame: baseline, 12weeks, 24weeks
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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).
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baseline, 12weeks, 24weeks
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change from baseline of Metabolism and Body composition in 12 and 24 weeks
Time Frame: baseline, 12weeks, 24weeks
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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.
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baseline, 12weeks, 24weeks
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change from baseline of muscle strength and endurance in 12 and 24 weeks
Time Frame: baseline, 12 weeks, 24 weeks
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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.
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baseline, 12 weeks, 24 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Chia-Ling Chen, MD,PhD, Chang Gung Memorial Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2015
Primary Completion (Actual)
October 1, 2019
Study Completion (Actual)
October 1, 2019
Study Registration Dates
First Submitted
October 10, 2016
First Submitted That Met QC Criteria
February 8, 2017
First Posted (Estimate)
February 9, 2017
Study Record Updates
Last Update Posted (Actual)
May 28, 2020
Last Update Submitted That Met QC Criteria
May 27, 2020
Last Verified
August 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 103-7425A3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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