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

Last updated: July 28, 2021
Sponsor: Chang Gung Memorial Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cerebral Palsy

Treatment

N/A

Clinical Study ID

NCT04101994
201701518A0
  • Ages 5-20
  • All Genders

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.

Eligibility Criteria

Inclusion

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, orurinary tract infection
  • No active problems of epilepsy and EEG without epileptiform discharge

Exclusion

Exclusion Criteria:

  • Metabolic disorders, such as inborn error of metabolism, electrolyte, and endocrinedisorders
  • Active infectious disease, such as meningitis and encephalitis
  • Patients with active medical problems, such as pneumonia, upper gastrointestinalbleeding, 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 andunstable health condition

Study Design

Total Participants: 80
Study Start date:
June 26, 2018
Estimated Completion Date:
June 06, 2022

Study 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).

Connect with a study center

  • Chang Gung Memorial Hospital

    Taoyuan, 333
    Taiwan

    Active - Recruiting

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