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

Primary Purpose

Cerebral Palsy

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Virtual cycling training
Repetitive transcranial magnetic stimulation
Transcranial electric stimulation
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring virtual cycling training, Non-invasive brain stimulation, repetitive transcranial magnetic stimulation, transcranial electric stimulation

Eligibility Criteria

5 Years - 20 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chang Gung Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Experimental

Sham Comparator

Experimental

Experimental

Experimental

Sham Comparator

Arm Label

VCT and real rTMS

VCT and sham rTMS

real rTMS

sham rTMS

VCT and real TES

VCT and sham TES

real TES

sham TES

Arm Description

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.

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

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

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

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

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

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

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

Outcomes

Primary Outcome Measures

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.
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).

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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).
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).
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.
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.
Change from baseline Myoton at after six weeks of treatment and three month
The comparison of baseline of Myoton for CP after different therapy.
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.
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.

Full Information

First Posted
September 22, 2019
Last Updated
July 28, 2021
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04101994
Brief Title
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

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 26, 2018 (Actual)
Primary Completion Date
March 6, 2022 (Anticipated)
Study Completion Date
June 6, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
virtual cycling training, Non-invasive brain stimulation, repetitive transcranial magnetic stimulation, transcranial electric stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
VCT and real rTMS
Arm Type
Experimental
Arm Description
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.
Arm Title
VCT and sham rTMS
Arm Type
Experimental
Arm Description
In virtual cycling training and sham theta burst stimulation group (VCT + iTBS group), they received VCT and sham TBS stimulation.
Arm Title
real rTMS
Arm Type
Experimental
Arm Description
In intermittent theta burst stimulation (iTBS group), they received iTBS (80% of active motor threshold) on affected hemisphere.
Arm Title
sham rTMS
Arm Type
Sham Comparator
Arm Description
In sham theta burst stimulation (sham TBS group), they received sham TBS stimulation.
Arm Title
VCT and real TES
Arm Type
Experimental
Arm Description
In virtual cycling training and transcranial electric stimulation group (VCT + TES group), they received TES stimulation over motor cortex.
Arm Title
VCT and sham TES
Arm Type
Experimental
Arm Description
In virtual cycling training and sham transcranial electric stimulation group (VCT + sham TES group), they received VCT and sham TES stimulation.
Arm Title
real TES
Arm Type
Experimental
Arm Description
In transcranial electric stimulation group (TES group), they received TES stimulation over motor cortex.
Arm Title
sham TES
Arm Type
Sham Comparator
Arm Description
In sham transcranial electric stimulation group (sham TES group), they received sham TES stimulation.
Intervention Type
Device
Intervention Name(s)
Virtual cycling training
Intervention Description
Virtual cycling training is a convenient and easy approach for muscle strengthening.
Intervention Type
Device
Intervention Name(s)
Repetitive transcranial magnetic stimulation
Intervention Description
Intermittent theta burst stimulation produces short TBS trains intermittently to facilitate cortical excitability.
Intervention Type
Device
Intervention Name(s)
Transcranial electric stimulation
Intervention Description
TES is a constant current with low intensity delivered to the skull through surface electrodes.
Primary Outcome Measure Information:
Title
Change from baseline Bruininks- Oseretsky Test of Motor Proficiency II at after six weeks of treatment and three month
Description
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.
Time Frame
baseline, after 6 weeks of treatment, 3 months
Title
Change from baseline Goal Attainment Scale at after six weeks of treatment and three month
Description
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).
Time Frame
baseline, after 6 weeks of treatment, 3 months
Secondary Outcome Measure Information:
Title
Change from baseline Melbourne Assessment 2 at after six weeks of treatment and three month
Description
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.
Time Frame
baseline, after 6 weeks of treatment, 3 months
Title
Change from baseline Quality of upper extremity skills test at after six weeks of treatment and three month
Description
The Quality of upper extremity skills test (QUEST) is an outcome measure that evaluates movement patterns and hand function in children with cerebral palsy.
Time Frame
baseline, after 6 weeks of treatment, 3 months
Title
Change from baseline Box and block test at after six weeks of treatment and three month
Description
The Box and Block Test (BBT) measures unilateral gross manual dexterity.
Time Frame
baseline, after 6 weeks of treatment, 3 months
Title
Change from baseline Nine-Hole test at after six weeks of treatment and three month
Description
The Nine-Hole Peg Test (NHPT) is used to measure finger dexterity in patients with various neurological diagnoses.
Time Frame
baseline, after 6 weeks of treatment, 3 months
Title
Change from baseline Functional Independence Measure at after six weeks of treatment and three month
Description
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.
Time Frame
baseline, after 6 weeks of treatment, 3 months
Title
Change from baseline Pediatric Motor Activity Log at after six weeks of treatment and three month
Description
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.
Time Frame
baseline, after 6 weeks of treatment, 3 months
Title
Change from baseline ABILHAND Questionnaire at after six weeks of treatment and three month
Description
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.
Time Frame
baseline, after 6 weeks of treatment, 3 months
Title
Change from baseline Assessment of Preschool Children's Participation at after six weeks of treatment and three month
Description
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).
Time Frame
baseline, after 6 weeks of treatment, 3 months
Title
Change from baseline Children Assessment of Participation and Enjoyment at after six weeks of treatment and three month
Description
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).
Time Frame
baseline, after 6 weeks of treatment, 3 months
Title
Change from baseline Cerebral Palsy Quality of Life at after six weeks of treatment and three month
Description
The comparison of baseline of Cerebral Palsy Quality of Life for CP after different therapy.
Time Frame
baseline, after 6 weeks of treatment, 3 months
Title
Change from baseline Motor Evoked Potential at after six weeks of treatment and three month
Description
The comparison of baseline of Motor Evoked Potential for CP after different therapy.
Time Frame
baseline, after 6 weeks of treatment, 3 months
Title
Change from baseline Myoton at after six weeks of treatment and three month
Description
The comparison of baseline of Myoton for CP after different therapy.
Time Frame
baseline, after 6 weeks of treatment, 3 months
Title
Change from baseline Hand dynamometer at after six weeks of treatment and three month
Description
The comparison of baseline of hand dynamometer for CP after different therapy.
Time Frame
baseline, after 6 weeks of treatment, 3 months
Title
Change from baseline Motion analysis at after six weeks of treatment and three month
Description
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.
Time Frame
baseline, after 6 weeks of treatment, 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chia-Ling Chen, MD, PhD
Phone
+886-3-3281200
Ext
8148
Email
clingchen@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chia-Ling Chen, MD, PhD
Organizational Affiliation
Chang Gung Memorial Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Chang Gung Memorial Hospital
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chia-Ling Chen, MD, PhD
Phone
+886-3-3281200
Ext
8147
Email
clingchen@gmail.com
First Name & Middle Initial & Last Name & Degree
Chia-Ling Chen, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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