Cerebral PalsyNCT03048851
Efficacy of New Protocols in the Treatment of Upper Limb Dysfunctions in Patients With Cerebral Palsy
A study testing Low dosage SES group, High dosage SES group and VRCIT group in people with Cerebral Palsy, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Immediate and maintaining Efficacy of new protocols in the treatment of upper limb dysfunctions in patients with cerebral palsy. Read more about this study
- Who is it for?
- Ages 2 to 24 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Low dosage SES group, High dosage SES group and VRCIT group
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2015to Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Cerebral Palsy
- Being tested
- Low dosage SES group, High dosage SES group, VRCIT group, VRCIT+SES group, traditional rehabilitation program
- Keywords
- Cerebral palsy, sensory electrical stimulation, virtual reality constraint-induced therapy
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dosage SES groupDevice
Also called novel sensory electrical stimulation program
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.
High dosage SES groupDevice
Also called novel sensory electrical stimulation program
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.
VRCIT groupDevice
Also called virtual reality based Constraint-induced therapy
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.
VRCIT+SES groupDevice
Also called combined VR based Constraint-induced therapy & SES
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).
traditional rehabilitation programProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Low dosage SES group | Experimental | 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. Receives: Device: Low dosage SES group |
| High dosage SES group | Experimental | 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. Receives: Device: High dosage SES group |
| VRCIT group | Experimental | 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. Receives: Device: VRCIT group |
| VRCIT+SES group | Experimental | VRCIT+SES group received the VRCIT and SES training in addition to traditional rehabilitation. Receives: Device: VRCIT+SES group |
| traditional rehabilitation group | Active comparator | Shame control group received the shame SES and traditional rehabilitation programs. Receives: Procedure: traditional rehabilitation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline of muscle tone and basic motor abilities 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.). 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.
Measured: baseline, 12weeks, 24weeks
Secondary outcomes (8)
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.
Measured: baseline, 12weeks, 24weeks
change from baseline of activities of daily living (ADL) in 12 and 24 weeks
The ADL assessments included Functional Independence Measure for Children (WeeFIM) and Pediatric Motor Activity Log (PMAL). The measure is a composite.
Measured: baseline, 12weeks, 24weeks
change from baseline of bone mineral density in 12 and 24 weeks
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).
Measured: baseline, 12weeks, 24weeks
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(InBody230). The measure is a composite.
Measured: baseline, 12weeks, 24weeks
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.
Measured: baseline, 12weeks, 24weeks
change from baseline of muscle strength and endurance in 12 and 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.
Measured: baseline, 12 weeks, 24 weeks
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.
Measured: baseline, 12 weeks, 24 weeks
change from baseline of reaction-time in 12 and 24 weeks
To examine the reaction time by CANTAB® software.
Measured: baseline, 12 weeks ,24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2017 (estimated)
- Study startAug 2015
- Primary completionOct 2019
- Study completionOct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chia-Ling Chen, MD,PhD, Study director, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03048851
- Sponsor's protocol ID
- 103-7425A3
- Status last verified
- Aug 2019
- First submitted
- 10 Oct 2016
- Last updated
- 28 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate and Maintaining Efficacy of New Protocols in the Treatment of Upper Limb Dysfunctions in Patients With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT03048851
- Acronym / sponsor ID
- 103-7425A3
- Conditions
- Cerebral Palsy
- Keywords
- Cerebral palsy, sensory electrical stimulation, virtual reality constraint-induced therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Oct 2019 (actual)
- Study completion
- Oct 2019 (actual)
- First posted
- 9 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Low dosage SES group | Experimental | Device: Low dosage SES groupLow 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. |
| High dosage SES group | Experimental | Device: High dosage SES groupHigh 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 | Experimental | Device: VRCIT groupVRCIT 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 | Experimental | Device: VRCIT+SES groupVRCIT+SES group received the VRCIT and SES training in addition to traditional rehabilitation. |
| traditional rehabilitation group | Active comparator | Procedure: traditional rehabilitation programShame control group received the shame SES and traditional rehabilitation programs. |
Who may qualify
- Ages
- 2 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
Key exclusion criteria (7 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low dosage SES groupAlso: novel sensory electrical stimulation programThe 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. | Device | Low dosage SES group |
| High dosage SES groupAlso: novel sensory electrical stimulation programThe 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. | Device | High dosage SES group |
| VRCIT groupAlso: virtual reality based Constraint-induced therapyThe 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. | Device | VRCIT group |
| VRCIT+SES groupAlso: combined VR based Constraint-induced therapy & SESThe 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). | Device | VRCIT+SES group |
| traditional rehabilitation programThe 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. | Procedure or surgery | traditional rehabilitation group |
Primary outcome
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
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.
8 secondary outcomes
change from baseline of quality of life in 12 and 24 weeks
Time frame: baseline, 12weeks, 24weeks
change from baseline of activities of daily living (ADL) in 12 and 24 weeks
Time frame: baseline, 12weeks, 24weeks
change from baseline of bone mineral density in 12 and 24 weeks
Time frame: baseline, 12weeks, 24weeks
change from baseline of Metabolism and Body composition in 12 and 24 weeks
Time frame: baseline, 12weeks, 24weeks
change from baseline of kinematic analysis in 12 and 24 weeks
Time frame: baseline, 12weeks, 24weeks
change from baseline of muscle strength and endurance in 12 and 24 weeks
Time frame: baseline, 12 weeks, 24 weeks
change from baseline of severity in 12 and 24 weeks
Time frame: baseline, 12 weeks, 24 weeks
change from baseline of reaction-time in 12 and 24 weeks
Time frame: baseline, 12 weeks ,24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chia-Ling Chen, MD,PhD study director
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low dosage SES group, High dosage SES group and VRCIT group in people with Cerebral Palsy, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2020.