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CompletedNCT04101994Updated Jan 27, 2026

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

An interventional study of Virtual cycling training and Repetitive transcranial magnetic stimulation in Cerebral Palsy, sponsored by Chang Gung Memorial Hospital. Completed at 1 site in Taiwan. Open to participants aged 5 Years to 20 Years. Per ClinicalTrials.gov, last updated 2026-01-27.

Sponsored by Chang Gung Memorial Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 2 months after the study started (first participant enrolled Jun 2018, registered Sep 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
5 Years to 20 Years
Sex
All
01

Study 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.

Read the 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).

02

Conditions studied

  • Cerebral Palsy

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Keywords

  • virtual cycling training
  • Non-invasive brain stimulation
  • repetitive transcranial magnetic stimulation
  • transcranial electric stimulation
03

In context

Cerebral Palsy

1,853 studies on the registry are indexed under Cerebral Palsy; 435 are open to participants now.

This study's enrollment of 36 is close to the median of 33 across 1,368 interventional studies indexed under Cerebral Palsy.

Browse Cerebral Palsy studies →

Lead sponsor

Chang Gung Memorial Hospital is the lead sponsor of 1,064 studies on the registry; 235 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 20 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
36 participants (actual)

Study arms

  • 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.

    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.

    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.

    Device: Repetitive transcranial magnetic stimulation

  • Sham comparator
    sham rTMS

    In sham theta burst stimulation (sham TBS group), they received sham TBS stimulation.

    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.

    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.

    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.

    Device: Transcranial electric stimulation

  • Sham comparator
    sham TES

    In sham transcranial electric stimulation group (sham TES group), they received sham TES stimulation.

    Device: Transcranial electric stimulation

Interventions

  • DeviceVirtual cycling training

    Virtual cycling training is a convenient and easy approach for muscle strengthening.

  • DeviceRepetitive transcranial magnetic stimulation

    Intermittent theta burst stimulation produces short TBS trains intermittently to facilitate cortical excitability.

  • DeviceTranscranial electric stimulation

    TES is a constant current with low intensity delivered to the skull through surface electrodes.

06

What researchers measure

Primary outcomes

  1. Change from baseline Bruininks- Oseretsky Test of Motor Proficiency II at after six weeks of treatment and three month

    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.

    Time frame: baseline, after 6 weeks of treatment, 3 months

  2. Change from baseline Goal Attainment Scale at after six weeks of treatment and three month

    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).

    Time frame: baseline, after 6 weeks of treatment, 3 months

Secondary outcomes

  1. Change from baseline Melbourne Assessment 2 at after six weeks of treatment and three month

    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.

    Time frame: baseline, after 6 weeks of treatment, 3 months

  2. Change from baseline Quality of upper extremity skills test at after six weeks of treatment and three month

    The Quality of upper extremity skills test (QUEST) is an outcome measure that evaluates movement patterns and hand function in children with cerebral palsy.

    Time frame: baseline, after 6 weeks of treatment, 3 months

  3. Change from baseline Box and block test at after six weeks of treatment and three month

    The Box and Block Test (BBT) measures unilateral gross manual dexterity.

    Time frame: baseline, after 6 weeks of treatment, 3 months

  4. Change from baseline Nine-Hole test at after six weeks of treatment and three month

    The Nine-Hole Peg Test (NHPT) is used to measure finger dexterity in patients with various neurological diagnoses.

    Time frame: baseline, after 6 weeks of treatment, 3 months

  5. Change from baseline Functional Independence Measure at after six weeks of treatment and three month

    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.

    Time frame: baseline, after 6 weeks of treatment, 3 months

  6. Change from baseline Pediatric Motor Activity Log at after six weeks of treatment and three month

    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.

    Time frame: baseline, after 6 weeks of treatment, 3 months

  7. Change from baseline ABILHAND Questionnaire at after six weeks of treatment and three month

    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.

    Time frame: baseline, after 6 weeks of treatment, 3 months

  8. Change from baseline Assessment of Preschool Children's Participation at after six weeks of treatment and three month

    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).

    Time frame: baseline, after 6 weeks of treatment, 3 months

  9. Change from baseline Children Assessment of Participation and Enjoyment at after six weeks of treatment and three month

    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).

    Time frame: baseline, after 6 weeks of treatment, 3 months

  10. Change from baseline Cerebral Palsy Quality of Life at after six weeks of treatment and three month

    The comparison of baseline of Cerebral Palsy Quality of Life for CP after different therapy.

    Time frame: baseline, after 6 weeks of treatment, 3 months

  11. Change from baseline Motor Evoked Potential at after six weeks of treatment and three month

    The comparison of baseline of Motor Evoked Potential for CP after different therapy.

    Time frame: baseline, after 6 weeks of treatment, 3 months

  12. Change from baseline Myoton at after six weeks of treatment and three month

    The comparison of baseline of Myoton for CP after different therapy.

    Time frame: baseline, after 6 weeks of treatment, 3 months

  13. Change from baseline Hand dynamometer at after six weeks of treatment and three month

    The comparison of baseline of hand dynamometer for CP after different therapy.

    Time frame: baseline, after 6 weeks of treatment, 3 months

  14. Change from baseline Motion analysis at after six weeks of treatment and three month

    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.

    Time frame: baseline, after 6 weeks of treatment, 3 months

07

Study locations

1 site
  • Chang Gung Memorial Hospital
    Taoyuan, Taoyuan 333, Taiwan
08

References and documents

Publications

  • Chen IC, Chen CL, Chen HC, Chou IJ, Chen RS, Chung CY, Wu KP, Lin KC, Wu CY. Preliminary effects of intermittent theta burst stimulation combined with virtual reality-based cycling training on upper extremity function in children with cerebral palsy: a double-blind randomized crossover trial. BMC Neurol. 2026 Jul 2. doi: 10.1186/s12883-026-05053-7. Online ahead of print. PubMed 42393577 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04101994
Lead sponsor
Chang Gung Memorial Hospital
Responsible party
Sponsor
First posted
Sep 25, 2019
Start date
Jun 26, 2018
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025
Last update
Jan 27, 2026

Study contacts

Chia-Ling Chen, MD, PhD
study director · Chang Gung Memorial Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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