Cerebral PalsyNCT02039284
Efficacy of New Protocols in the Treatment of Upper Limb Dysfunctions in Patients With Cerebral Palsy
A study testing SES, VCT and VRCIT in people with Cerebral Palsy, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 3 to 20 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- SES, VCT and VRCIT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteTaiwan
- Study dates
- May 2013to Mar 2018
- 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 3 to 20 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 3-20 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
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.
Read the detailed description
This study will proposed 3 novel protocols, including upper extremity (UE) VCT, UE SES, and virtual reality based CIT (VRCIT) in the treatment of upper limb dysfunction in patients with CP. investigators hypothesize that the functioning and health-related quality of life (HRQOL) will improve through biomechanical and physiological changes after different treatment protocols in patients with CP. The biomechanical and physiological changes varied depending on different treatment protocols. This project aims to: 1. the immediate effects of new protocols in these patients through biomechanical, physiological, and clinical measures; 2. the maintaining effects of new protocols in these patients through biomechanical, physiological, and clinical measures;3. the most effective treatment protocol; 3. the biomechanical and physiological mechanism underlying clinical improvement; and 5. the clinical predictors influencing the outcome for new protocols.
This 4-year project will recruit an estimated 92-100 patients with CP. A blind, randomized controlled trial (RCT) study was designed. In the phase I (1st year), investigators will set-up the experimental protocols and perform pilot study. Twenty patients will be randomized into 4 groups: SES, VCT, VRCIT, and shame control groups. In the phase II (2nd -3rd year), 36-40 patients will be randomized into 2 groups: SES and shame control groups. In the phase III (3rd -4th year), 36-40 patients will be randomized into 2 groups:VCT and VRCIT groups. The outcome measures include biomechanical, physiological (muscle tone, muscle strength and endurance, kinematics, bone density, body compositions, metabolism), and clinical assessments, including functioning (motor impairment, movement and participation) and HRQOL, based on the International Classification of Functioning, Disability and Health (ICF) framework. The outcome measures will be administered at before, immediately after 12-week intervention, and 3-month follow-up assessments.
This project is significant for the translational and evidence-based medicine on CP neurorehabilitation. The research will offer valuable biomechanical and physiological biomarker that support motor control models proposed to account for motor problems and new protocol intervention in these patients.
- Conditions
- Cerebral Palsy
- Being tested
- SES, VCT, VRCIT, traditional rehabilitation program
- Keywords
- Cerebral palsy, novel intervention, sensory electrical stimulation, virtual reality, cycling training, constraint-induced therapy, biomechanical, physiology, outcome
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SESDevice
Also called novel sensory electrical stimulation program
SES group received the SES 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 three times 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 for 20-30 minutes and arm with wrap for 20-30 minutes. The pulse width was set to 300 us for all stimulation levels. The frequency was set to 40-50 Hz.
VCTDevice
Also called The upper extremity programsvirtual cycling training program
The UE VCT programs were conducted three times per week, for 12 weeks. Each UE VCT session involved upper limb cycling training followed by UE training in addition to home program. The cycling program consisted of a warm-up exercise, twenty repetitions of hand push-up movements in the sitting position, UE cycling, and a cool-down exercise. The warm-up and cool-down exercises involved stretching and relaxing the head, neck, and the upper and lower body.
VRCITDevice
Also called virtual reality based Constraint-induced therapy
VRCIT group received the VRCIT training in addition to traditional rehabilitation, conducted three times 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, in addition to home program, and restraint of the less affected UE for 3.5 to 4 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.
traditional rehabilitation programDevice
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 |
|---|---|---|
| SES group | Experimental | SES group received the SES training in addition to traditional rehabilitation. Each SES session involved electrical stimulation followed by UE training in addition to home program. Receives: Device: SES |
| VCT group | Experimental | VCT group received the VCT training in addition to traditional rehabilitation.Each UE VCT session involved upper limb cycling training followed by UE training in addition to home program. The cycling program consisted of a warm-up exercise, twenty repetitions of hand push-up movements in the sitting position, UE cycling, and a cool-down exercise. Receives: Device: VCT |
| 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 3.5 to 4 hours per day. Receives: Device: VRCIT |
| traditional rehabilitation group | Active comparator | Shame control group received the shame SES and traditional rehabilitation programs. Receives: Device: 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 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.).
Measured: baseline, 12weeks, 24weeks
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.
Measured: baseline, 12 weeks, 24 weeks
Secondary outcomes (10)
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.
Measured: baseline, 12weeks, 24weeks
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), Pediatric Motor Activity Log (PMAL), etc.. The measure is a composite.
Measured: baseline, 12weeks, 24weeks
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.
Measured: baseline, 12weeks, 24 weeks
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).
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(InBody220). 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
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.
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 posted17 Jan 2014 (estimated)
- Study startMay 2013
- Primary completionJan 2018
- Study completionMar 2018
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
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Responsible party
- Sponsor
- Investigators
- Chia-Ling Chen, MD,PhD, Study director, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02039284
- Sponsor's protocol ID
- 101-5261A3
- Status last verified
- Nov 2017
- First submitted
- 18 Sep 2013
- Last updated
- 7 Jun 2018
- 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 7 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of New Protocols in the Treatment of Upper Limb Dysfunctions in Patients With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT02039284
- Acronym / sponsor ID
- 101-5261A3
- Conditions
- Cerebral Palsy
- Keywords
- Cerebral palsy, novel intervention, sensory electrical stimulation, virtual reality, cycling training, constraint-induced therapy, biomechanical, physiology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- May 2013 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 17 Jan 2014 (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.
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.
Detailed description
This study will proposed 3 novel protocols, including upper extremity (UE) VCT, UE SES, and virtual reality based CIT (VRCIT) in the treatment of upper limb dysfunction in patients with CP. investigators hypothesize that the functioning and health-related quality of life (HRQOL) will improve through biomechanical and physiological changes after different treatment protocols in patients with CP. The biomechanical and physiological changes varied depending on different treatment protocols. This project aims to: 1. the immediate effects of new protocols in these patients through biomechanical, physiological, and clinical measures; 2. the maintaining effects of new protocols in these patients through biomechanical, physiological, and clinical measures;3. the most effective treatment protocol; 3. the biomechanical and physiological mechanism underlying clinical improvement; and 5. the clinical predictors influencing the outcome for new protocols.
This 4-year project will recruit an estimated 92-100 patients with CP. A blind, randomized controlled trial (RCT) study was designed. In the phase I (1st year), investigators will set-up the experimental protocols and perform pilot study. Twenty patients will be randomized into 4 groups: SES, VCT, VRCIT, and shame control groups. In the phase II (2nd -3rd year), 36-40 patients will be randomized into 2 groups: SES and shame control groups. In the phase III (3rd -4th year), 36-40 patients will be randomized into 2 groups:VCT and VRCIT groups. The outcome measures include biomechanical, physiological (muscle tone, muscle strength and endurance, kinematics, bone density, body compositions, metabolism), and clinical assessments, including functioning (motor impairment, movement and participation) and HRQOL, based on the International Classification of Functioning, Disability and Health (ICF) framework. The outcome measures will be administered at before, immediately after 12-week intervention, and 3-month follow-up assessments.
This project is significant for the translational and evidence-based medicine on CP neurorehabilitation. The research will offer valuable biomechanical and physiological biomarker that support motor control models proposed to account for motor problems and new protocol intervention in these patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SES group | Experimental | Device: SESSES group received the SES training in addition to traditional rehabilitation. Each SES session involved electrical stimulation followed by UE training in addition to home program. |
| VCT group | Experimental | Device: VCTVCT group received the VCT training in addition to traditional rehabilitation.Each UE VCT session involved upper limb cycling training followed by UE training in addition to home program. The cycling program consisted of a warm-up exercise, twenty repetitions of hand push-up movements in the sitting position, UE cycling, and a cool-down exercise. |
| VRCIT group | Experimental | Device: VRCITVRCIT 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 3.5 to 4 hours per day. |
| traditional rehabilitation group | Active comparator | Device: traditional rehabilitation programShame control group received the shame SES and traditional rehabilitation programs. |
Who may qualify
- Ages
- 3 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- diagnosis with spastic CP with Gross Motor Function Classification System(GMFCS) levels I-IV
- aged 3-20 years
- ability to undergo clinical assessment
- ability to comprehend commands and cooperate during an examination
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| SESAlso: novel sensory electrical stimulation programSES group received the SES 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 three times 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 for 20-30 minutes and arm with wrap for 20-30 minutes. The pulse width was set to 300 us for all stimulation levels. The frequency was set to 40-50 Hz. | Device | SES group |
| VCTAlso: The upper extremity programsvirtual cycling training programThe UE VCT programs were conducted three times per week, for 12 weeks. Each UE VCT session involved upper limb cycling training followed by UE training in addition to home program. The cycling program consisted of a warm-up exercise, twenty repetitions of hand push-up movements in the sitting position, UE cycling, and a cool-down exercise. The warm-up and cool-down exercises involved stretching and relaxing the head, neck, and the upper and lower body. | Device | VCT group |
| VRCITAlso: virtual reality based Constraint-induced therapyVRCIT group received the VRCIT training in addition to traditional rehabilitation, conducted three times 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, in addition to home program, and restraint of the less affected UE for 3.5 to 4 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. | Device | VRCIT group |
| traditional rehabilitation programThe 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. | Device | traditional rehabilitation group |
Primary outcome
change from baseline of muscle tone 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.).
change from baseline of Basic motor abilities in 12 and 24 weeks
Time frame: baseline, 12 weeks, 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.
10 secondary outcomes
change from baseline of basic motor functions in 12 and 24 weeks
Time frame: baseline, 12weeks, 24weeks
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 participation in 12 and 24 weeks
Time frame: baseline, 12weeks, 24 weeks
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 7 Jun 2018.
- 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 SES, VCT and VRCIT 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 7 Jun 2018. 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 of the upper limb muscles in 12 and 24 weeks (time frame: baseline, 12weeks, 24weeks). The study lists 2 primary outcomes in all. 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 7 Jun 2018.