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Cerebral PalsyNCT04101994

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

A study testing Virtual cycling training, Repetitive transcranial magnetic stimulation and Transcranial electric stimulation in people with Cerebral Palsy, run by Chang Gung Memorial Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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-reality cycling training (VCT) program was to enhance promising muscle strength and motor function through promoting the participant compliance and… Read more about this study

Who is it for?
Ages 5 to 20 years
Conditions the study is for
Cerebral Palsy
What is being tested?
Virtual cycling training, Repetitive transcranial magnetic stimulation and Transcranial electric stimulation
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
36 participants
Where
1 siteTaiwan
Study dates
26 Jun 2018to 31 Dec 2025
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 5 to 20 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Chang Gung Memorial Hospital

    Taoyuan, Taoyuan, 333

Other trials in Taiwan

About this study

Official title: Augmented Effects of Virtual-reality Cycling Training on Upper Limb Motor Functions by Noninvasive Brain Stimulation in Patients With Cerebral Palsy

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).

Conditions
Cerebral Palsy
Being tested
Virtual cycling training, Repetitive transcranial magnetic stimulation, Transcranial electric stimulation
Keywords
virtual cycling training, Non-invasive brain stimulation, repetitive transcranial magnetic stimulation, transcranial electric stimulation
Medical subject headings
Cerebral Palsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Virtual cycling trainingDevice

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

  • Repetitive transcranial magnetic stimulationDevice

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

  • Transcranial electric stimulationDevice

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

Study groups in NCT04101994
Study groupRoleWhat they receive
VCT and real rTMSExperimentalIn 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.
Receives: Device: Virtual cycling training; Device: Repetitive transcranial magnetic stimulation
VCT and sham rTMSExperimentalIn virtual cycling training and sham theta burst stimulation group (VCT + iTBS group), they received VCT and sham TBS stimulation.
Receives: Device: Virtual cycling training; Device: Repetitive transcranial magnetic stimulation
real rTMSExperimentalIn intermittent theta burst stimulation (iTBS group), they received iTBS (80% of active motor threshold) on affected hemisphere.
Receives: Device: Repetitive transcranial magnetic stimulation
sham rTMSSham comparatorIn sham theta burst stimulation (sham TBS group), they received sham TBS stimulation.
Receives: Device: Repetitive transcranial magnetic stimulation
VCT and real TESExperimentalIn virtual cycling training and transcranial electric stimulation group (VCT + TES group), they received TES stimulation over motor cortex.
Receives: Device: Virtual cycling training; Device: Transcranial electric stimulation
VCT and sham TESExperimentalIn virtual cycling training and sham transcranial electric stimulation group (VCT + sham TES group), they received VCT and sham TES stimulation.
Receives: Device: Virtual cycling training; Device: Transcranial electric stimulation
real TESExperimentalIn transcranial electric stimulation group (TES group), they received TES stimulation over motor cortex.
Receives: Device: Transcranial electric stimulation
sham TESSham comparatorIn sham transcranial electric stimulation group (sham TES group), they received sham TES stimulation.
Receives: Device: Transcranial electric stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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).

    Measured: baseline, after 6 weeks of treatment, 3 months

Secondary outcomes (14)

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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).

    Measured: 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).

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: baseline, after 6 weeks of treatment, 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2019
  2. Study start26 Jun 2018
  3. Primary completion31 Dec 2025
  4. Study completion31 Dec 2025

Resources

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
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04101994
Sponsor's protocol ID
201701518A0
Status last verified
May 2018
First submitted
22 Sep 2019
Last updated
27 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A study testing Virtual cycling training, Repetitive transcranial magnetic stimulation and Transcranial electric stimulation 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 8 inclusion and 8 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 27 Jan 2026. 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. Some participants in this study may receive a placebo. 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 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 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?

On the ClinicalTrials.gov record for NCT04101994, which also lists 1 linked publication.

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 27 Jan 2026; AzTrials last refreshed its copy on 2 Nov 2026.

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