The aim of this study is to evaluate the clinical effectiveness, feasibility and acceptability of a novel home-based noninvasive neuromodulation therapy (AscenZ-IV Stimulator) that utilizes transcranial Pulse Current Stimulation (tPCS) and Transcutaneous Electrical Nerve Stimulation (TENS) for children and adolescents with cerebral palsy as a community-based intervention by families and healthcare providers.
CP patients who participate in this research study,
caregivers of the CP patients taking part in this research study,
implementation staff
qualified clinicians not involved in the intervention or refused to recommend the intervention device (AscenZion-IV stimulator) for management of CP.
CP patients with epilepsy with recent seizures (<12 months) will be excluded for safety given the theoretical risks of seizures (abnormal brain electrical discharges) with transcranial electrical stimulation. We will include those with well controlled epilepsy with no recent seizures (within 12 months).
Individuals with history of uncontrolled epileptic disorder, seizures, brain tumour or trauma, and mental disease
Individuals with electrical implanted stimulatory device, such as pacemaker or defibrillator
Individuals with medical devices that are affected by magnets, such as programmable shunts.
Crossover
AscenZ-IV neuromodulation device
DeviceAscenZ-IV neuromodulation device is a novel treatment modality that utilizes 2 non-invasive neuromodulation technologies - tPCS and TENS - concurrently within a device. The home-based, non-invasive AscenZ-IV Stimulator therapy has been shown to improve spasticity and motor function
Spasticity
Physical assessments using the Modified Tardieu Scale (MTS) for upper and/or lower limbs are performed to assess improvement in spasticity with the aim of reducing the R2-R1 value. R1 refers to 'first catch or resistance' or the angle at which there is initial resistance when the muscle is stretched passively. R2 refers to 'end range resistance' or the angle at which the muscle reaches full range of motion under passive stretch, where resistance decreases or disappears. Min (R2-R1) = 0° indicates no spasticity (better outcome); Max (R2-R1) = 90° indicates severe spasticity (worse outcome).
Gross Motor Function
Improvement in gross motor function for CP patients is assessed using the Gross Motor Function Measure 66 (GMFM-66) score. Scoring is based on a 4-point scale (0 - does not initiate, 1 - initiates, 2 - partially completes, 3 - completes, NT - not tested) for each of the 66 items. The minimum GMFM-66 score is 0 (worse outcome), which indicates that the child is unable to perform any of the tasks in the assessment. The maximum GMFM-66 score is 100 (better outcome), which indicates that the child can perform all tasks to the full extent expected for their age.
Upper Limb Motor Function
Improvement in manual ability for children with upper limb impairments is assessed using the ABILHAND-Kids assessment composed of 21 assessment items, each scored on a 3-point scale (Impossible, Difficult, Easy). The raw score is undergone Rasch conversion to get a global score ranging from 0 to 40. A higher score indicates better manual ability. ABILHAND-Kids is only assessed for participants with hemi/quadriplegia and MACS I to III.
Gait Function
The Gait Outcomes Assessment List (GOAL) is used to assess the quality of walking and how it impacts daily life and mobility. Assessment items include activities of daily living and independence, gait function and mobility, pain, discomfort and fatigue, physical activities, sport and recreation, gait pattern and appearance, as well as use of braces and mobility aids. Each item is scored from 0 (severe limitation) to 5 (no limitation), or 0 (very unhappy) to 4 (very happy), thus giving a total score ranging from 0 (severe limitations in all areas) to maximum 236 (no limitation or optimal walking function in all areas). GOAL is only assessed for CP patients of GMFCS II or III.
Cerebral Palsy-specific Health-related Quality of Life
Cerebral Palsy-specific Health-related Quality of Life is assessed using the Pediatric Quality of Life Inventory™ 3.0 Cerebral Palsy Module (PedsQL™ 3.0 Cerebral Palsy Module). Items are measured on a 5-point Likert scale from 0 (Never a problem) to 4 (Almost always a problem). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. Scores are transformed to a 1 to 100 scale. Higher scores indicate lower problems thus better cerebral palsy-specific health-related quality of life.
Drooling
Daniel Drooling Impact Scale Questionnaire (DDISQ) is used to assess reduction of drooling. The 20-item questionnaire was designed with responses scored on a 5-point scale with increasing quantity or severity in impact (in a consistent manner). The summated score will be used for analysis and interpretation. A higher value represents a worse outcome.
Behavior
For participants with behavioral issues, the Aberrant Behavior Checklist is to assess improvement in behavior. The ABC comprises 58 items scored on a 4-point Likert scale (0 = no problem, 1 = minor problem, 2 = moderate problem, 3 = severe problem). Item scores are additive, and higher scores reflect more severe levels of challenging behaviour.
Dystonia Severity
For participants with dystonia, the Dystonia Severity Action Plan (DSAP) is used to assess reduction of dystonia. Grade 1 to 5 - Severity increases as the grade increases.
Estimated Patient Cost
Cost effectiveness of the device is assessed using the economic evaluation forms at baseline and post-intervention, as well as medical records. Data collected include direct medical costs outside of the hospital (ex. private health services) as well as direct non-medical costs (ex. home modifications, equipment, etc.), indirect costs (ex. lost productivity) and willingness to pay. A higher cost indicates larger burden to the patient, thus worse outcome.
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KK Women's and Children's Hospital
Lead sponsor
National University Hospital, Singapore
Collaborator
