Clinical trial NCT04101994: Augmented Effects of Virtual-reality Cycling Training on Upper Limb Motor Functions by NIBS in Patients With CP
Official title: Augmented Effects of Virtual-reality Cycling Training on Upper Limb Motor Functions by Noninvasive Brain Stimulation in Patients With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebral Palsy
Keywords: virtual cycling training
Non-invasive brain stimulation
repetitive transcranial magnetic stimulation
transcranial electric stimulation
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2019-09-25
Enrollment: 80
Sex: ALL
Minimum age (years): 5
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline Bruininks- Oseretsky Test of Motor Proficiency II at after six weeks of treatment and three month
timeFrame: baseline, after 6 weeks of treatment, 3 months
measure: Change from baseline Goal Attainment Scale at after six weeks of treatment and three month
timeFrame: baseline, after 6 weeks of treatment, 3 months
Secondary outcomes:
measure: Change from baseline Melbourne Assessment 2 at after six weeks of treatment and three month
timeFrame: baseline, after 6 weeks of treatment, 3 months
measure: Change from baseline Quality of upper extremity skills test at after six weeks of treatment and three month
timeFrame: baseline, after 6 weeks of treatment, 3 months
measure: Change from baseline Box and block test at after six weeks of treatment and three month
timeFrame: baseline, after 6 weeks of treatment, 3 months
measure: Change from baseline Nine-Hole test at after six weeks of treatment and three month
timeFrame: baseline, after 6 weeks of treatment, 3 months
measure: Change from baseline Functional Independence Measure at after six weeks of treatment and three month
timeFrame: baseline, after 6 weeks of treatment, 3 months
measure: Change from baseline Pediatric Motor Activity Log at after six weeks of treatment and three month
timeFrame: baseline, after 6 weeks of treatment, 3 months
measure: Change from baseline ABILHAND Questionnaire at after six weeks of treatment and three month
timeFrame: baseline, after 6 weeks of treatment, 3 months
measure: Change from baseline Assessment of Preschool Children's Participation at after six weeks of treatment and three month
timeFrame: baseline, after 6 weeks of treatment, 3 months
measure: Change from baseline Children Assessment of Participation and Enjoyment at after six weeks of treatment and three month
timeFrame: baseline, after 6 weeks of treatment, 3 months
measure: Change from baseline Cerebral Palsy Quality of Life at after six weeks of treatment and three month
timeFrame: baseline, after 6 weeks of treatment, 3 months
measure: Change from baseline Motor Evoked Potential at after six weeks of treatment and three month
timeFrame: baseline, after 6 weeks of treatment, 3 months
measure: Change from baseline Myoton at after six weeks of treatment and three month
timeFrame: baseline, after 6 weeks of treatment, 3 months
measure: Change from baseline Hand dynamometer at after six weeks of treatment and three month
timeFrame: baseline, after 6 weeks of treatment, 3 months
measure: Change from baseline Motion analysis at after six weeks of treatment and three month
timeFrame: baseline, after 6 weeks of treatment, 3 months
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Chia-Ling Chen, MD, PhD
role: STUDY_DIRECTOR
References: