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

NCT ID: NCT04101994

Last Updated: 2026-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-26

Study Completion Date

2025-12-31

Brief Summary

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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

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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

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Cerebral Palsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Virtual cycling training

Intervention Type DEVICE

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

Repetitive transcranial magnetic stimulation

Intervention Type DEVICE

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

VCT and sham rTMS

In virtual cycling training and sham theta burst stimulation group (VCT + iTBS group), they received VCT and sham TBS stimulation.

Group Type EXPERIMENTAL

Virtual cycling training

Intervention Type DEVICE

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

Repetitive transcranial magnetic stimulation

Intervention Type DEVICE

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

real rTMS

In intermittent theta burst stimulation (iTBS group), they received iTBS (80% of active motor threshold) on affected hemisphere.

Group Type EXPERIMENTAL

Repetitive transcranial magnetic stimulation

Intervention Type DEVICE

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

sham rTMS

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

Group Type SHAM_COMPARATOR

Repetitive transcranial magnetic stimulation

Intervention Type DEVICE

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

VCT and real TES

In virtual cycling training and transcranial electric stimulation group (VCT + TES group), they received TES stimulation over motor cortex.

Group Type EXPERIMENTAL

Virtual cycling training

Intervention Type DEVICE

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

Transcranial electric stimulation

Intervention Type DEVICE

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

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.

Group Type EXPERIMENTAL

Virtual cycling training

Intervention Type DEVICE

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

Transcranial electric stimulation

Intervention Type DEVICE

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

real TES

In transcranial electric stimulation group (TES group), they received TES stimulation over motor cortex.

Group Type EXPERIMENTAL

Transcranial electric stimulation

Intervention Type DEVICE

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

sham TES

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

Group Type SHAM_COMPARATOR

Transcranial electric stimulation

Intervention Type DEVICE

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

Interventions

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Virtual cycling training

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

Intervention Type DEVICE

Repetitive transcranial magnetic stimulation

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

Intervention Type DEVICE

Transcranial electric stimulation

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chia-Ling Chen, MD, PhD

Role: STUDY_DIRECTOR

Chang Gung Memorial Hospital

Locations

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Chang Gung Memorial Hospital

Taoyuan District, Taoyuan, Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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201701518A0

Identifier Type: -

Identifier Source: org_study_id

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