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

NCT04101994 | Completed DMC

• 1 other identifier: 201701518A0
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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.

  baseline, after 6 weeks of treatment, 3 months

• 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).

  baseline, after 6 weeks of treatment, 3 months

Secondary Outcomes (14)

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

  baseline, after 6 weeks of treatment, 3 months

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

  baseline, after 6 weeks of treatment, 3 months

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

  baseline, after 6 weeks of treatment, 3 months

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

  baseline, after 6 weeks of treatment, 3 months

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

  baseline, after 6 weeks of treatment, 3 months

Study Arms (8)

VCT and real rTMS

EXPERIMENTAL

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

VCT and sham rTMS

EXPERIMENTAL

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

real rTMS

EXPERIMENTAL

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

Device: Repetitive transcranial magnetic stimulation

sham rTMS

SHAM COMPARATOR

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

Device: Repetitive transcranial magnetic stimulation

VCT and real TES

EXPERIMENTAL

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

VCT and sham TES

EXPERIMENTAL

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

real TES

EXPERIMENTAL

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

Device: Transcranial electric stimulation

sham TES

SHAM COMPARATOR

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

Device: Transcranial electric stimulation

Interventions

Transcranial electric stimulation DEVICE

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

VCT and real TES; VCT and sham TES; real TES; sham TES

Virtual cycling training DEVICE

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

VCT and real TES; VCT and real rTMS; VCT and sham TES; VCT and sham rTMS

Repetitive transcranial magnetic stimulation DEVICE

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

VCT and real rTMS; VCT and sham rTMS; real rTMS; sham rTMS

Eligibility Criteria

• Age: 5 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, Taoyuan, 333, Taiwan

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Chia-Ling Chen, MD, PhD

  Chang Gung Memorial Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2019
• First Posted: September 25, 2019
• Study Start: June 26, 2018
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 27, 2026

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)