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Augmented Effects of Virtual-reality Cycling Training on Upper Limb Motor Functions by NIBS in Patients With CP

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ClinicalTrials.gov Identifier: NCT04101994
Recruitment Status : Recruiting
First Posted : September 25, 2019
Last Update Posted : February 7, 2020
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

Tracking Information
First Submitted Date  ICMJE September 22, 2019
First Posted Date  ICMJE September 25, 2019
Last Update Posted Date February 7, 2020
Actual Study Start Date  ICMJE June 26, 2018
Estimated Primary Completion Date March 6, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 5, 2020)
  • Change from baseline Bruininks- Oseretsky Test of Motor Proficiency II at after six weeks of treatment and three month [ Time Frame: baseline, after 6 weeks of treatment, 3 months ]
    The Bruininks- Oseretsky Test of Motor Proficiency II (BOT-2) provides an overview of fine and gross motor skills in children and school-aged adolescents.
  • Change from baseline Goal Attainment Scale at after six weeks of treatment and three month [ Time Frame: baseline, after 6 weeks of treatment, 3 months ]
    Goal Attainment Scale (GAS) is used to help a person with cerebral palsy and their family develop personal goals for therapy (for each item minimum value is -2 and maximum value is 2, higher scores mean a better outcome).
Original Primary Outcome Measures  ICMJE
 (submitted: September 22, 2019)
  • Change from baseline of Bruininks- Oseretsky Test of Motor Proficiency II for CP after 6 weeks treatment and 3 months follow-up [ Time Frame: baseline, after 6 weeks of treatment, 3 months ]
    The BOT provides an overview of fine and gross motor skills in children and school-aged adolescents.
  • Change from baseline of Goal Attainment Scale for CP after 6 weeks treatment and 3 months follow-up [ Time Frame: baseline, after 6 weeks of treatment, 3 months ]
    GAS is used to help a person with cerebral palsy and their family develop personal goals for therapy.
Change History Complete list of historical versions of study NCT04101994 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 5, 2020)
  • Change from baseline Melbourne Assessment 2 at after six weeks of treatment and three month [ Time Frame: baseline, after 6 weeks of treatment, 3 months ]
    The Melbourne Assessment 2 (MA2) is a valid and reliable tool for evaluating quality of upper limb movement in children with a neurological impairment aged 2.5 to 15 years.
  • Change from baseline Quality of upper extremity skills test at after six weeks of treatment and three month [ Time Frame: baseline, after 6 weeks of treatment, 3 months ]
    The Quality of upper extremity skills test (QUEST) is an outcome measure that evaluates movement patterns and hand function in children with cerebral palsy.
  • Change from baseline Box and block test at after six weeks of treatment and three month [ Time Frame: baseline, after 6 weeks of treatment, 3 months ]
    The Box and Block Test (BBT) measures unilateral gross manual dexterity.
  • Change from baseline Nine-Hole test at after six weeks of treatment and three month [ Time Frame: baseline, after 6 weeks of treatment, 3 months ]
    The Nine-Hole Peg Test (NHPT) is used to measure finger dexterity in patients with various neurological diagnoses.
  • Change from baseline Functional Independence Measure at after six weeks of treatment and three month [ Time Frame: baseline, after 6 weeks of treatment, 3 months ]
    Functional Independence Measure for Children:Applicable to infants and adolescents. The main purpose is to understand and track children's life function performance, progress and goal achievement. There are three main areas: self-care, mobility, and cognition. The score is from 1 to 7 points, 1 is completely dependent, and 7 is completely independent.
  • Change from baseline Pediatric Motor Activity Log at after six weeks of treatment and three month [ Time Frame: baseline, after 6 weeks of treatment, 3 months ]
    The Pediatric Motor Activity Log (PMAL) is a structured interview intended to examine how often and how well a child uses his/her involved upper extremity (UE) in their natural environment outside the therapeutic setting.
  • Change from baseline ABILHAND Questionnaire at after six weeks of treatment and three month [ Time Frame: baseline, after 6 weeks of treatment, 3 months ]
    The ABILHAND questionnaire assesses bimanual ability as an interview-based test focused on the patient's perceived difficulty. The ABILHAND-KIDS questionnaire is filled in by the parent of the child by rating the child's perceived difficulty of bimanual activities.
  • Change from baseline Assessment of Preschool Children's Participation at after six weeks of treatment and three month [ Time Frame: baseline, after 6 weeks of treatment, 3 months ]
    Preferences for Activity of Children(APCP): For children between the ages of two and five, the questionnaire model is used to allow parents to circle the level. There are 45 questions in total, so that the case or parent can review the activities in the past 4 months and ask if the child have done this activity (1 point means yes, 0 points means no).
  • Change from baseline Children Assessment of Participation and Enjoyment at after six weeks of treatment and three month [ Time Frame: baseline, after 6 weeks of treatment, 3 months ]
    Children Assessment of Participation and Enjoyment(CAPE): Applicable to children or adolescents between the ages of six and twenty one, through questionnaires through self-reports or interviews, a total of 55 questions, asking children about the activities involved in the past four months (1 point for yes, 0 for no).
  • Change from baseline Cerebral Palsy Quality of Life at after six weeks of treatment and three month [ Time Frame: baseline, after 6 weeks of treatment, 3 months ]
    The comparison of baseline of Cerebral Palsy Quality of Life for CP after different therapy.
  • Change from baseline Motor Evoked Potential at after six weeks of treatment and three month [ Time Frame: baseline, after 6 weeks of treatment, 3 months ]
    The comparison of baseline of Motor Evoked Potential for CP after different therapy.
  • Change from baseline Myoton at after six weeks of treatment and three month [ Time Frame: baseline, after 6 weeks of treatment, 3 months ]
    The comparison of baseline of Myoton for CP after different therapy.
  • Change from baseline Hand dynamometer at after six weeks of treatment and three month [ Time Frame: baseline, after 6 weeks of treatment, 3 months ]
    The comparison of baseline of hand dynamometer for CP after different therapy.
  • Change from baseline Motion analysis at after six weeks of treatment and three month [ Time Frame: baseline, after 6 weeks of treatment, 3 months ]
    All participants will be instructed to perform a series of upper-extremity tasks. The tasks include reaching and grasping. An 8-camera motion analysis system (Vicon system, 3-D Oxfort Metrics Ltd, Oxford, UK) is used in conjunction with a personal computer to capture the movement of markers placed on the participant's body; analog signals were collected simultaneously. Movements were recorded at 120 Hz and digitally low-pass filtered at 5 Hz using a second-order Butterworth filter. Reference markers are placed on the distal interphalangeal joints of the thumb and index finger, the styloid process of the ulna, proximal end of the second metacarpal, and the object.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 22, 2019)
  • Change from baseline of Melbourne Assessment 2 for CP after 6 weeks treatment and 3 months follow-up [ Time Frame: baseline, after 6 weeks of treatment, 3 months ]
    The Melbourne Assessment 2 is a valid and reliable tool for evaluating quality of upper limb movement in children with a neurological impairment aged 2.5 to 15 years.
  • Change from baseline of Quality of upper extremity skills test for CP after 6 weeks treatment and 3 months follow-up [ Time Frame: baseline, after 6 weeks of treatment, 3 months ]
    The QUEST is an outcome measure that evaluates movement patterns and hand function in children with cerebral palsy.
  • Change from baseline of Box and block test for CP after 6 weeks treatment and 3 months follow-up [ Time Frame: baseline, after 6 weeks of treatment, 3 months ]
    The Box and Block Test (BBT) measures unilateral gross manual dexterity.
  • Change from baseline of Nine-Hole test for CP after 6 weeks treatment and 3 months follow-up [ Time Frame: baseline, after 6 weeks of treatment, 3 months ]
    The Nine-Hole Peg Test (9HPT) is used to measure finger dexterity in patients with various neurological diagnoses.
  • Change from baseline of Functional Independence Measure for Children for CP after 6 weeks treatment and 3 months follow-up [ Time Frame: baseline, after 6 weeks of treatment, 3 months ]
    Functional Independence Measure for Children:Applicable to infants and adolescents. The main purpose is to understand and track children's life function performance, progress and goal achievement. There are three main areas: self-care, mobility, and cognition. The score is from 1 to 7 points, 1 is completely dependent, and 7 is completely independent.
  • Change from baseline of Pediatric Motor Activity Log for Children for CP after 6 weeks treatment and 3 months follow-up [ Time Frame: baseline, after 6 weeks of treatment, 3 months ]
    The PMAL is a structured interview intended to examine how often and how well a child uses his/her involved upper extremity (UE) in their natural environment outside the therapeutic setting.
  • Change from baseline of ABILHAND Questionnaire for Children for CP after 6 weeks treatment and 3 months follow-up [ Time Frame: baseline, after 6 weeks of treatment, 3 months ]
    The ABILHAND questionnaire assesses bimanual ability as an interview-based test focused on the patient's perceived difficulty. The ABILHAND-KIDS questionnaire is filled in by the parent of the child by rating the child's perceived difficulty of bimanual activities.
  • Change from baseline of Assessment of Preschool Children's Participation for Children for CP after 6 weeks treatment and 3 months follow-up [ Time Frame: baseline, after 6 weeks of treatment, 3 months ]
    Preferences for Activity of Children(APCP): For children between the ages of two and five, the questionnaire model is used to allow parents to circle the level. There are 45 questions in total, so that the case or parent can review the activities in the past 4 months and ask if the child have done this activity (1 point means yes, 0 points means no).
  • Change from baseline of Children Assessment of Participation and Enjoyment and Preferences for Activity of Children for Children for CP after 6 weeks treatment and 3 months follow-up [ Time Frame: baseline, after 6 weeks of treatment, 3 months ]
    Children Assessment of Participation and Enjoyment(CAPE): Applicable to children or adolescents between the ages of six and twenty one, through questionnaires through self-reports or interviews, a total of 55 questions, asking children about the activities involved in the past four months (1 point for yes, 0 for no).
  • Change from baseline of Cerebral Palsy Quality of Life for CP after 6 weeks treatment and 3 months follow-up [ Time Frame: baseline, after 6 weeks of treatment, 3 months ]
    The comparison of baseline of Cerebral Palsy Quality of Life for CP after different therapy.
  • Change from baseline of Motor Evoked Potential for CP after 6 weeks treatment and 3 months follow-up [ Time Frame: baseline, after 6 weeks of treatment, 3 months ]
    The comparison of baseline of Motor Evoked Potential for CP after different therapy.
  • Change from baseline of MYOTON for CP after 6 weeks treatment and 3 months follow-up [ Time Frame: baseline, after 6 weeks of treatment, 3 months ]
    The comparison of baseline of Myoton for CP after different therapy.
  • Change from baseline of hand dynamometer for CP after 6 weeks treatment and 3 months follow-up [ Time Frame: baseline, after 6 weeks of treatment, 3 months ]
    The comparison of baseline of hand dynamometer for CP after different therapy.
  • Change from baseline of Motion analysis for CP after 6 weeks treatment and 3 months follow-up [ Time Frame: baseline, after 6 weeks of treatment, 3 months ]
    All participants will be instructed to perform a series of upper-extremity tasks. The tasks include reaching and grasping. An 8-camera motion analysis system (Vicon system, 3-D Oxfort Metrics Ltd, Oxford, UK) is used in conjunction with a personal computer to capture the movement of markers placed on the participant's body; analog signals were collected simultaneously. Movements were recorded at 120 Hz and digitally low-pass filtered at 5 Hz using a second-order Butterworth filter. Reference markers are placed on the distal interphalangeal joints of the thumb and index finger, the styloid process of the ulna, proximal end of the second metacarpal, and the object.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Augmented Effects of Virtual-reality Cycling Training on Upper Limb Motor Functions by NIBS in Patients With CP
Official Title  ICMJE Augmented Effects of Virtual-reality Cycling Training on Upper Limb Motor Functions by Noninvasive Brain Stimulation in Patients With Cerebral Palsy
Brief 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-reality cycling training (VCT) program was to enhance promising muscle strength and motor function through promoting the participant compliance and motivation. Non-invasive brain stimulation (NIBS), such as repetitive transcranial magnetic stimulation (rTMS) and transcranial electric stimulation (TES) has potential to augment the training effects in motor neurorehabilitation via the modulation on neuroplasticity. Therefore, this study propose a novel intervention protocol to induce superior benefits on upper extremity (UE) motor function in patients with CP.
Detailed Description This study aims to investigate the augmented effects of VCT on neuromotor control and UE motor function by NIBS in patients with CP. We hypothesize that NIBS can augment the VCT effects on neuromotor control and UE motor function in patients with CP because combined therapy integrated peripheral modification techniques (VCT) and central modulation (NIBS). These effects may further enhance the activity of daily living (ADL), participation, and health related quality of life (HRQOL). This project is executed in the following two phases: to investigate the augmented effects of VCT on neuromotor control and UE motor function in patients with CP by rTMS in phase 1 (0-1.5 years) and tCS in phase 2 (1.5-3 years).
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Cerebral Palsy
Intervention  ICMJE
  • Device: Virtual cycling training
    Virtual cycling training is a convenient and easy approach for muscle strengthening.
  • Device: Repetitive transcranial magnetic stimulation
    Intermittent theta burst stimulation produces short TBS trains intermittently to facilitate cortical excitability.
  • Device: Transcranial electric stimulation
    TES is a constant current with low intensity delivered to the skull through surface electrodes.
Study Arms  ICMJE
  • Experimental: VCT and real rTMS
    In virtual cycling training and intermittent theta burst stimulation group (VCT + iTBS group), they received VCT and iTBS (80% of active motor threshold) on affected hemisphere.
    Interventions:
    • Device: Virtual cycling training
    • Device: Repetitive transcranial magnetic stimulation
  • Experimental: VCT and sham rTMS
    In virtual cycling training and sham theta burst stimulation group (VCT + iTBS group), they received VCT and sham TBS stimulation.
    Interventions:
    • Device: Virtual cycling training
    • Device: Repetitive transcranial magnetic stimulation
  • Experimental: real rTMS
    In intermittent theta burst stimulation (iTBS group), they received iTBS (80% of active motor threshold) on affected hemisphere.
    Intervention: Device: Repetitive transcranial magnetic stimulation
  • Sham Comparator: sham rTMS
    In sham theta burst stimulation (sham TBS group), they received sham TBS stimulation.
    Intervention: Device: Repetitive transcranial magnetic stimulation
  • Experimental: VCT and real TES
    In virtual cycling training and transcranial electric stimulation group (VCT + TES group), they received TES stimulation over motor cortex.
    Interventions:
    • Device: Virtual cycling training
    • Device: Transcranial electric stimulation
  • Experimental: VCT and sham TES
    In virtual cycling training and sham transcranial electric stimulation group (VCT + sham TES group), they received VCT and sham TES stimulation.
    Interventions:
    • Device: Virtual cycling training
    • Device: Transcranial electric stimulation
  • Experimental: real TES
    In transcranial electric stimulation group (TES group), they received TES stimulation over motor cortex.
    Intervention: Device: Transcranial electric stimulation
  • Sham Comparator: sham TES
    In sham transcranial electric stimulation group (sham TES group), they received sham TES stimulation.
    Intervention: Device: Transcranial electric stimulation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 22, 2019)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 6, 2022
Estimated Primary Completion Date March 6, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of CP according to clinical criteria
  • Age 5-20 years
  • No use of botulinum toxin in the past 4 months
  • No significant perceptual or communication disturbances
  • No other peripheral or central nervous system dysfunction
  • No active inflammatory or pathologic changes in upper limb joints during the previous 6 months
  • No active medical problems, such as pneumonia, upper gastrointestinal bleeding, or urinary tract infection
  • No active problems of epilepsy and EEG without epileptiform discharge

Exclusion Criteria:

  • Metabolic disorders, such as inborn error of metabolism, electrolyte, and endocrine disorders
  • Active infectious disease, such as meningitis and encephalitis
  • Patients with active medical problems, such as pneumonia, upper gastrointestinal bleeding, or urinary tract infection
  • Poor compliance or intolerance for the TMS therapy
  • Subjects with metallic implants or pregnancy.
  • EEG show epileptiform discharge
  • Patients with family history of epilipsy
  • Patients with symptoms that are restricted from tDCS, such as epilepsy, migraine and unstable health condition
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 20 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Chia-Ling Chen, MD, PhD +886-3-3281200 ext 8148 clingchen@gmail.com
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04101994
Other Study ID Numbers  ICMJE 201701518A0
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Chang Gung Memorial Hospital
Study Sponsor  ICMJE Chang Gung Memorial Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Chia-Ling Chen, MD, PhD Chang Gung Memorial Hospital
PRS Account Chang Gung Memorial Hospital
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP