Effectiveness in Improving Gait and Feasibility of a Transcutaneous Electrical Stimulation Garment in Children With Cerebral Palsy in Singapore
Phase: NA
Conditions: Cerebral Palsy, Spasticity, Muscle
Sponsor: KK Women's and Children's Hospital

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CLINICAL TRIAL PROTOCOL 
 
PROTOCOL TITLE: 
Effectiveness in Improving gait and Value of a Transcutaneous Electrical Stimulation garment in children 
with Cerebral Palsy in Singapore 
 
PROTOCOL NUMBER:  
2 
 
PROTOCOL VERSION:  
2 
PROTOCOL DATE:  
30 Mar 2020 
 
PRINCIPAL INVESTIGATOR:  
Dr Ng Zhi Min  
Consultant  
KK Women’s and Children’s Hospital  
 
 
CO-INVESTIGATORS: 
Dr Yeo Tong Hong   
Consultant  
KK Women’s and Children’s Hospital  
 
Maheswari Vellaichamy  
Senior Physiotherapist  
KK Women’s and Children’s Hospital  
 
Shelly-Anne Sherwood  
Senior Physiotherapist  
KK Women’s and Children’s Hospital  
 
Asila Alia K O Noordin 
Senior Physiotherapist  
KK Women’s and Children’s Hospital  
 
Lindsey Jean Ross Weller  
Senior Physiotherapist  
KK Women’s and Children’s Hospital 
 
Ng Shin Huey 
 

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Principal Physiotherapist  
KK Women’s and Children’s Hospital 
 
Tan Ling Ying 
Senior Staff Nurse  
KK Women’s and Children’s Hospital  
 
 
 
 
 

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Table of Contents 
1 
BACKGROUND AND RATIONALE ................................................................................................ 6 
1.1 
GENERAL INTRODUCTION ................................................................................................................. 6 
1.2 
RATIONALE AND JUSTIFICATION FOR THE STUDY .................................................................................... 6 
1.2.1 
RATIONALE FOR THE STUDY PURPOSE .................................................................................................. 7 
1.2.2 
RATIONALE FOR DOSES SELECTED ...................................................................................................... 7 
1.2.3 
RATIONALE FOR STUDY POPULATION ................................................................................................... 7 
1.2.4 
RATIONALE FOR STUDY DESIGN ......................................................................................................... 7 
2 
HYPOTHESIS AND OBJECTIVES ................................................................................................. 7 
2.1 
HYPOTHESIS ................................................................................................................................. 7 
2.2 
PRIMARY OBJECTIVES ...................................................................................................................... 7 
2.3 
SECONDARY OBJECTIVES .................................................................................................................. 7 
2.4 
POTENTIAL RISKS AND BENEFITS: ....................................................................................................... 7 
2.4.1 
POTENTIAL RISKS ........................................................................................................................... 7 
2.4.2 
POTENTIAL BENEFITS ...................................................................................................................... 8 
3 
STUDY POPULATION .................................................................................................................. 8 
3.1 
LIST THE NUMBER AND NATURE OF SUBJECTS TO BE ENROLLED .................................................................. 8 
3.2 
CRITERIA FOR RECRUITMENT AND RECRUITMENT PROCESS ........................................................................ 8 
3.3 
INCLUSION CRITERIA ...................................................................................................................... 8 
3.4 
EXCLUSION CRITERIA ...................................................................................................................... 8 
3.5 
SUBJECT REPLACEMENT ................................................................................................................... 8 
4 
STUDY DESIGN ........................................................................................................................... 8 
4.1 
RANDOMISATION AND BLINDING ........................................................................................................ 9 
4.2 
CONTRACEPTION AND PREGNANCY TESTING .......................................................................................... 9 
4.3 
STUDY VISITS AND PROCEDURES ........................................................................................................ 9 
4.3.1 
SCREENING VISITS AND PROCEDURES ................................................................................................ 10 
4.3.2 
STUDY VISITS AND PROCEDURES ...................................................................................................... 10 
4.3.3 
FINAL STUDY VISIT: ..................................................................................................................... 13 
4.3.4 
POST STUDY FOLLOW UP AND PROCEDURES ........................................................................................ 13 
4.4 
DISCONTINUATION/WITHDRAWAL .................................................................................................... 13 
4.4.1 
DISCONTINUATION CRITERIA ........................................................................................................... 13 
4.4.2 
DISCONTINUATION VISIT AND PROCEDURES ........................................................................................ 13 
5 
TRIAL MATERIALS .................................................................................................................... 14 
5.1 
TRIAL PRODUCT (S) ...................................................................................................................... 14 
5.2 
STORAGE AND DRUG ACCOUNTABILITY ............................................................................................... 14 
6 
TREATMENT .............................................................................................................................. 14 
6.1 
RATIONALE FOR SELECTION OF DOSE ................................................................................................ 14 
6.2 
STUDY DRUG FORMULATIONS .............................................................. ERROR! BOOKMARK NOT DEFINED. 
6.3 
STUDY DRUG ADMINISTRATION ....................................................................................................... 14 
6.4 
SPECIFIC RESTRICTIONS / REQUIREMENTS .......................................................................................... 15 
6.5 
BLINDING ................................................................................................................................... 15 
6.6 
CONCOMITANT THERAPY ................................................................................................................. 15 
7 
SAFETY MEASUREMENTS ......................................................................................................... 15 
7.1 
DEFINITIONS .............................................................................................................................. 15 
7.2 
COLLECTING, RECORDING AND REPORTING OF SERIOUS ADVERSE EVENTS (SAES) TO CIRB ............................ 15 

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7.3 
COLLECTING, RECORDING AND REPORTING OF SERIOUS ADVERSE EVENTS (SAES) TO THE HEALTH SCIENCE 
AUTHORITY (HSA) ................................................................................................................................... 15 
7.4 
SAFETY MONITORING PLAN ............................................................................................................. 16 
7.5 
COMPLAINT HANDLING .................................................................................................................. 16 
8 
DATA ANALYSIS ....................................................................................................................... 16 
8.1 
DATA QUALITY ASSURANCE ............................................................................................................. 16 
8.2 
DATA ENTRY AND STORAGE ............................................................................................................ 16 
9 
SAMPLE SIZE AND STATISTICAL METHODS ............................................................................. 16 
9.1 
DETERMINATION OF SAMPLE SIZE ..................................................................................................... 16 
9.2 
STATISTICAL AND ANALYTICAL PLANS ................................................................................................ 16 
10 
DIRECT ACCESS TO SOURCE DATA/DOCUMENTS .................................................................... 16 
11 
QUALITY CONTROL AND QUALITY ASSURANCE ...................................................................... 17 
12 
ETHICAL CONSIDERATIONS .................................................................................................... 17 
12.1 
INFORMED CONSENT ..................................................................................................................... 17 
12.2 
CONFIDENTIALITY OF DATA AND PATIENT RECORDS .............................................................................. 17 
13 
PUBLICATIONS ......................................................................................................................... 18 
14 
RETENTION OF TRIAL DOCUMENTS ......................................................................................... 18 
15 
FUNDING AND INSURANCE ...................................................................................................... 18 
REFERENCES ..................................................................................... ERROR! BOOKMARK NOT DEFINED. 

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PROTOCOL SIGNATURE PAGE 
 
 
 
Protocol Title:  
Effectiveness in Improving gait and Value of a Transcutaneous Electrical Stimulation garment in children 
with Cerebral Palsy in Singapore 
 
Protocol Number: 2 
 
 
Protocol Version/ Date: 30/03/2020 
 
 
Sponsor Name: 
Funded by KKH Academic Medicine (AM) Research Start-Up July 2019 Grant Call 
Industrial Partner: Inerventions  
 
Declaration of Investigator 
 
I confirm that I have read the above-mentioned protocol and its attachments. I agree to conduct the 
described trial in compliance with all stipulations of the protocol, regulations and ICH E6 Guideline for 
Good Clinical Practice (GCP). 
 
  
 
 
Principal Investigator Name:  ______NG ZHI MIN ____________ 
                                                            
 
Principal Investigator Signature:  _______________________________________ 
                                                            
 
Date:  __________________________________________ 
                                                            
 
 
 
 
 
 
 

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1 
BACKGROUND AND RATIONALE 
 
Worldwide, the prevalence of cerebral palsy (CP) is 1.77-2.9 per 1000 live births.i,ii,iii CP describes a 
group of developmental disorders of movement and posture, attributed by a non-progressive 
interference, lesion, or abnormality in the immature brain, causing activity restriction or disability. 
CP is a complex condition that is also accompanied by disturbance in sensation, cognition, 
communication and/or behaviour as well as secondary musculoskeletal problems.ivCommon 
musculoskeletal problems in CP include spasticity and weakness which affect gait.  
Among the treatment modalities for CP, transcutaneous electrical nerve stimulation (TENS) or 
neuromuscular electrical stimulation (NMES) is one intervention that has been shown to be effective 
in muscle tone reduction. A systematic review showed significant evidence, based on 14 randomised 
controlled trials (RCTs) with 550 study participants evaluating the effect of TENS, for management 
of limb spasticity.v Another review of electrical stimulation for children with CP showed that use of 
NMES offered benefits such as increased muscle strength, range of motion and function in children 
with CP.vi In combination with dynamic splinting, NMES was more effective than either treatment 
on its own in improving function and posture. Two out of six TENS studies in a systematic review 
evaluating efficacy of electrical stimulation in improving motor function of children in CP reported 
statistically significant improvements, two studies reported no statistically significant effects but 
documented a perceived positive treatment effect as reported by parents/carers, and the remaining 
two case reports described improvements.vii A randomised placebo-controlled trial was conducted to 
investigate the efficacy of NMES and TES in 60 children with cerebral palsy.viii The electrical 
stimulation was only tested in legs with two electrodes (one proximal and one distal position). After 
16 weeks of treatment, no differences were observed for strength or function. However, statistically 
significant differences were observed between NMES and TES versus placebo for impact of 
disability, and the difference continued at the 6 week follow-up between TES versus placebo. 
 
1.1 General Introduction 
 
The Mollii suit is a new technology of electrical stimulation in the form of whole-body garment with 
multiple electrodes individually programmed to stimulate the selected muscles. Based on preliminary 
studies, it is suggested that the Mollii suit improves spasticity. Recent studies also proposed that it 
improves mobility, gait, function and quality of life. However, these studies are based on qualitative 
and subjective measures.  
 
1.2 Rationale and Justification for the Study 
 
Living with CP is challenging for the child as well as the family charged with their care and support 
needs. Many families seek effective and sustainable interventions to improve gait of their children 
with CP. Many families, however, are unable to adhere to frequent intensive centre-based therapy in 
view of its high cost and time commitment. An intervention that could be used at home, assessed 
periodically by health care professionals of a tertiary pediatric centre, that has a benefit on gait and 
motor function in children with CP might be feasible to families in the local Singapore healthcare 
setting.  
 

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1.2.1 Rationale for the Study Purpose 
 
Considering the potential of the Mollii Suit and the need for evidence, we aim to study the 
effectiveness in improving gait and the feasibility with the use of the Mollii suit in children with 
cerebral palsy in Singapore.   
 
1.2.2 Rationale for Doses Selected 
 
Preliminary studies have shown that the Mollii suit is effective with one hour every day to every 
other day use for as 2-8 weeks. After discussion with the industrial partner and with the primary 
objective of a change in gait in mind, a dosage of 1 hour every day for 4 weeks was decided.  
 
1.2.3 Rationale for Study Population 
 
Studies have shown that the Mollii suit was effective in improving spasticity and reducing pain in 
adults post stroke and children with cerebral palsy.ix,x,xi,xii,xiii  As we are studying improvement in 
gait, ambulant children with cerebral palsy is the target population and they have spasticity as their 
dominant motor feature.  
 
1.2.4 Rationale for Study Design 
 
This is a single-centre study that compares subjects before and after the intervention. As a wide range 
of age group is used in the study population, comparison is made in gait in the same individual.  
 
 
2 
HYPOTHESIS AND OBJECTIVES 
 
2.1 Hypothesis 
 
The Mollii suit is effective in improving gait in ambulant children with cerebral palsy 
 
2.2 Primary Objectives 
 
The primary objective is to assess the effectiveness of the Molli suit in improving gait in children 
with cerebral palsy, GMFCS I-III.  
 
Change in Gait Profile Score will be computed as primary outcome measure. Other measurements 
obtained in the gait analysis include Gait deviation index, gait speed and cadence etc.   
 
  
2.3 Secondary Objectives 
 
The secondary objective is to evaluate the acceptability, tolerance and compliance of the Mollii suit 
in children with cerebral palsy.  
 
2.4 Potential Risks and Benefits:  
 
2.4.1 Potential Risks 
 
Mollii suit may cause discomfort or tingling sensation to some people. Some people may have 
allergic reaction to the material of the suit. Otherwise, there is minimal risk in wearing the suit if 

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there are no contraindication. 
 
2.4.2 Potential Benefits 
 
The Mollii suit is potentially an effective adjunct intervention for children with cerebral palsy that 
can benefit gait and motor function. It can potentially reduce number of visits needed to tertiary 
hospital as the intervention can be performed at home. It will also reduce reliance on hospital based 
care and improve convenience for families. 
 
 
3 
STUDY POPULATION 
 
3.1 List The Number and Nature of Subjects to be enrolled 
 
This is a single centre study that will enrol up to 20 children with cerebral palsy.   
3.2 Criteria for Recruitment and Recruitment Process 
 
The eligible participants will be recruited from the families who receive services and/or medical 
follow-up at KKH. Information of the study and Consent Form will be provided to the families who 
show interest in the study.  
 
3.3 Inclusion Criteria 
 
• Aged 4-18 
• GMFCS level I to III 
• Spasticity as the dominant motor feature  
• Children agree to wear the Mollii suit as per procedures and consent to the study 
• Parents/carers agree to assist their child to wear the Mollii suit as per procedures 
• Medical practitioner’s approval  
 
3.4 Exclusion Criteria 
 
• Individuals with electrical implanted stimulatory device 
• Individuals with medical devices that are affected by magnets, such as programmable shunts. 
• Individuals with cardiovascular diseases, infectious diseases, malignance (cancer), fever, 
pregnancy, rashes or skin problems. 
• Individuals who have had Botulinum toxin done 6 months prior intervention or soft tissue 
release surgery done 6 months prior intervention.  
• Individuals who have had change in oral medication for spasticity 1 month prior intervention. 
 
3.5 Subject Replacement 
 
Subjects who drop out will not be replaced.  
 
4 
STUDY DESIGN 
 
This study will evaluate the effectiveness of improving gait with the use of the Mollii suit in children 

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with cerebral palsy with instrumented 3-dimensional gait analysis and objective standardised 
assessment tool at pre-intervention and at 1 month post intervention.  
 
This study will evaluate change in gait and function following a four week intervention period using 
a protocol of wearing the Mollii suit for one hour every day for four weeks. 
 
This study also evaluates the feasibility of the use of the Mollii suit intervention protocol by 
conducting qualitative interviews with parents immediately and 1 month after the intervention.  
Information on compliance, perception of acceptability, benefits or concerns, practicalities, cost and 
likelihood of using the intervention in the future will be collected.   
 
4.1 Randomisation and Blinding 
 
Randomisation and blinding will not be performed. 
4.2 Contraception and Pregnancy Testing 
 
Not applicable.  
4.3 Study Visits and Procedures 
 
Table 1: Assessment timeline and persons reporting or conducting the assessments. 
 
Parent 
Child 
Assessor 
Measure 
At Baseline  
Demographics, 
resource 
use 
questionnaire 
X 
X 
 
Questionnaire 
Instrumented 3D Gait analysis  
 
X 
X 
Gait 
kinetics 
and 
kinematics  
EQ-5D 
X 
X 
 
QoL/ health status  
ICF 
X 
 
X 
Performance/Body 
structure & function 
GMFM 
 
X 
X 
Performance/ 
activity (ICF) 
FAQ 
X 
X 
X 
Performance/Body 
structure & function 
10m walk test  
 
X 
X 
Performance/ 
activity (ICF) 
GAS 
X 
X 
X 
Expectation 
 Daily during the 4 week intervention 
Study Diary- compliance; activity;  
X 
 
 
 
Pain  
X 
X 
 
 
Immediately post intervention 
Instrumented 3D Gait analysis  
 
 
X 
Gait 
kinetics 
and 
kinematics  
EQ-5D 
X 
X 
 
QoL/ health status  
ICF 
X 
 
X 
Performance/Body 
structure & function 
GMFM 
 
X 
X 
Performance/ 
activity (ICF) 
FAQ 
X 
X 
X 
Performance/Body 

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structure & function 
10m walk test  
 
X 
X 
Performance/ 
activity (ICF) 
GAS 
X 
X 
X 
Expectation 
Feasibility/ Acceptability 
X 
 
 
Questionnaire 
1 months post intervention  
EQ-5D 
X 
X 
 
QoL/ health status  
ICF 
X 
 
X 
Performance/Body 
structure & function 
GMFM 
 
X 
X 
Performance/ 
activity (ICF) 
FAQ 
X 
X 
X 
Performance/Body 
structure & function 
10m walk test  
 
X 
X 
Performance/ 
activity (ICF) 
Feasibility/ Acceptability 
X 
 
 
Questionnaire 
 
 
4.3.1 Screening Visits and Procedures 
 
All KKH patients who are attending outpatient clinics for neurology service and/ or Physiotherapy 
and are diagnosed with cerebral will be screened accordingly to the inclusion and exclusion criteria 
as stated in the preceeding sections 3.2 to 3.4 by the doctors and/or physiotherapists in the clinic. 
Consent will be taken by anyone in the study team.  
 
4.3.2 Study Visits and Procedures 
 
Baseline 
Prior to commencement of intervention (within 2 weeks prior to fitting of Mollii suit), the child will 
undergo: 
I. 
An instrumented 3-dimensional gait analysis 
For the 3-dimensional gait analysis, patient is required to walk on a walkway of 
approximately 8 to10 metres long with 2 force-plates along the walkway. The patient will 
have skin markers placed on their body, majority on the lower extremities following the Plug-
in Model marker placement model by physiotherapist. The patient will be required to walk 
barefoot with and/or without walking aid repeatedly along the walk-way until 6 to 8 
successfully clean strike on the force plate. The VICON infra-red camera system will capture 
the trial and after which, the data will be analysed by the study team member.  
 
II. 
Questionnaire (Annex I and II) 
This consists of 2 sets of self-administer questionnaire for parent and child respectively. The 
child’s questionnaire on demographics, patient’s perception on own health, mobility, 
emotions, activity (EQ-5D, ICF see below) and pain. The parent’s questionnaire consist items 
on demographics, parent’s perception on child’s health, mobility, emotions, activity and 
resource use.   
 
III. 
EuroQoL (EQ-5D) 
EQ-5D is a standardised measure of health status in order to provide a simple, generic 
measure of health for clinical and economic appraisal.xiv The EQ-5D-Y is the child-friendly 

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version. EQ-5D consists of the descriptive system and the EQ visual analogue scale (EQ 
VAS). The descriptive system comprises 5 dimensions. The EQ VAS records the 
respondent’s self-rated health on a vertical, visual analogue scale where the endpoints are 
labelled ‘The best health you can imagine’ and ‘The worst health you can imagine’. Parent or 
caregiver will be answering EQ-5D based on what they think the child feels. Whenever 
possible, for a child who can communicate and self-report assessment, EQ5D-Y will be used.  
 
IV. 
ICF-CY 
The WHO International Classification of Functioning, Disability and Health, Children & 
Youth version (ICF-CY) is a measure to grade function of activities of daily living (ADLs).xv 
Few ICF-CY categories have been selected and graded based on the frequency, 
intrusiveness or severity of the specific impairment.  (refer Table below).xvi  
 
The ICF-CY categories assessed and grading for each patient before and after intervention 
 
ICF-CY categories 
Illustration of grading  
D420 Transferring oneself 
0 = No impairment/ difficulty  
1 = mild impairment/ difficulty 
(present <25% of time, intensity is tolerable, 
rare)  
2 = moderate impairment/ difficulty 
(present 
<50% 
of 
time, 
intensity 
is 
interfering in day-to-day life, occasional) 
3 = severe impairment/ difficulty 
(present >50% of time, intensity partially 
disruptive, often)  
4 = complete impairment/ difficulty 
(present >95% of time, intensity totally 
disruptive, constant) 
8 = not specified (insufficient information) 
9 = not applicable   
D4153 Maintaining a sitting position 
B1340 Amount of sleep 
B1342 Maintenance of sleep  
B1261 Agreeableness 
B7356 Tone of all muscles of the body 
B7650 Involuntary contractions of muscle  
B2800 Generalised pain  
 
V. 
Gross Motor Function measure (GMFM) (ANNEX VIII) 
The Gross Moor Function Measure (GMFM) is an assessment tool designed and evaluated to 
measure changes in gross motor function over time or with intervention in children with 
cerebral palsyxvii.  
 
VI. 
Functional Assessment Questionnaire (FAQ) (ANNEX VIII) 
The Functional Assessment Questionnaire (FAQ) is a 10 point scale (6–10 describe 
functional walkers with 10 being most able) which was designed specifically to be used as an 
outcome measure in individuals with physical disability.xviii 
 
VII. 
10 Metre Walk Test (ANNEX VIII) 
The 10 Metre Walk Test is a performance measure used to assess walking speed in metres per 
second over a short distance. It can be employed to determine functional mobility and gait.xix  
 
VIII. 
Goal Attainment Scale (GAS) (ANNEX VIII)   
GAS is an individualised outcome measure involving goal selection and goal scaling that is 

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standardised in order to calculate the extent to which a patient’s goals are met.xx  
 
 
Fitting 
Child will be fitted with the Mollii suit and settings will be programmed by the Mollii suit company, 
Inerventions. The suit will be administered by trained physiotherapists from KKH. Child brings the 
Mollii suit home.  
 
Intervention 
Throughout the intervention period of 4 weeks, child will be wearing the Mollii suit for 60 min/ day 
every day. Parent will be keeping logs of compliance use, activity and adverse effect daily during this 
period. Child will be using the log book to document pain during this period. (Annex III) 
 
Post-intervention 
Immediately after intervention, child will undergo instrumented 3- dimensional gait analysis and 
objective assessments. Child and parent complete a questionnaire (Annex IV and VI) on health 
outcome measures and feasibility/ acceptability outcomes (refer Table 1). 
 
1 months after intervention period, child will undergo objective assessments. Child and parent 
complete a questionnaire (Annex V and VII) on health outcome measures and feasibility/ 
acceptability outcomes (refer Table 1). 
 
 
Table 2: SUMMARY OF STUDY VISITS 
VIST 1: 
Pre-intervention assessments:  
- 
Instrumented 3-dimensional gait study 
- 
Questionaires (include EQ-5D, ICF) 
- 
GMFM 
- 
FAQ 
- 
10m walk test 
- 
GAS 
Patient will be charged for one PT 
session per standard care.  
Gait study is FOC  
 
VISIT 2: 
Collection of Mollii suit, settings for Mollii suit 
Signing of loan agreement 
 
@HOME 
4WEEKS 
Patient will wear Molli suit at home daily 1 hour 
for 4 weeks.  
Patient/ parent keep log logs of compliance use, 
pain and adverse effects.  
 
 
VISIT 3 
Return Mollii Suit  
Post-intervention assessments:  
- 
Instrumented 3-dimensional gait study 
- 
Questionaires (include EQ-5D, ICF) 
- 
GMFM 
Patient will be charged for one PT 
session per standard care.  
Gait study is FOC  
 

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- 
FAQ 
- 
10m walk test 
- 
GAS 
VISIT 4 
(1 MTH 
LATER) 
1month post-intervention assessments:  
- 
Questionaires (include EQ-5D, ICF) 
- 
GMFM 
- 
FAQ 
- 
10m walk test 
Patient will be charged for one PT 
session per standard care.  
 
 
 
4.3.3 Final Study Visit: 
 
As per section 4.3.2  
4.3.4 Post Study Follow up and Procedures 
 
Immediately after intervention, child will undergo instrumented 3- dimensional gait analysis and 
objective assessments, and complete a questionnaire on health outcome measures and feasibility/ 
acceptability outcomes.  
 
1 months after intervention period, child will undergo objective assessments, and complete a 
questionnaire on health outcome measures and feasibility/ acceptability outcomes.  
 
4.4 Discontinuation/Withdrawal 
 
4.4.1 Discontinuation Criteria 
 
Study intervention will be discontinued if subject is unable to tolerate the Mollii suit.  
4.4.2 Discontinuation Visit and Procedures 
 
Subjects may withdraw voluntarily from participation in the study at any time. If withdrawal occurs, 
subjects will still be asked to complete a questionnaire to study the reason for withdrawal. No gait 
analysis and other objective assessments will be done.  
 
 
 

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5 
TRIAL MATERIALS 
 
5.1 Trial Product (s) 
 
The Mollii suit 
The Molli suit is an innovative approach for non-invasive, electrical stimulation with multiple 
electrodes incorporated in a whole-body suit.xxi It is a transcutaneous electrical stimulation therapy 
which is at the 'sub-sensory level' and involves e-stim above the threshold for feeling the stimulation 
but below the threshold to get a muscle contraction. 
 
HSA approval 
The Mollii suit is an electrical and neuromuscular stimulator classified as a class IIa medical device. 
Approval from Health Science Authority Singapore has to be obtained.   
 
Technical Information of the Mollii suit: 
- 
Power supply – 4 AAA batteries 
- 
Voltage – 20V 
- 
Pulse width – 25-175 us 
- 
Frequency - 20Hz 
- 
Pulse appearance - square wave 
- 
Channels – 40 
- 
Electrodes – 58 
- 
Electrode material Silicone rubber 
- 
Fabric material – Nylon 82%, Spandex 18% 
 
5.2   Storage  
The Mollii suits will be stored in a locked cupboard in Rehabilitation department. 
 
 
6 
TREATMENT 
 
6.1 Rationale for Selection of Dose of Intervention 
 
Preliminary studies have shown that the Mollii suit is effective with one-hour every day to every 
other day use for as 2-8 weeks. After discussion with the industrial partner and with the primary 
objective of change in gait in mind, a dosage of one hour everyday use for 4 weeks was decided.  
 
6.2 Intervention settings  
 
The intervention is the Mollii suit which is fitted and programmed by the Mollii suit distributor, 
Inerventions, and will be administered by trained physiotherapists from KKH.  
 
6.3 Intervention Administration 
 
Participants will be involved in the Intervention phase of the study for 4 weeks with treatment 
duration of 60 min/ session every day.   
 

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6.4 Specific Restrictions / Requirements  
 
Nil as long as exclusion criteria is not met.  
6.5 Blinding 
 
Blinding is not done.  
6.6 Concomitant therapy 
 
Subjects can continue regular standard care.  
 
7 
SAFETY MEASUREMENTS 
 
7.1 Definitions 
 
 
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation 
subject administered a pharmaceutical product and which does not necessarily have a causal 
relationship with this treatment. An adverse event (AE) can therefore be any unfavourable and 
unintended sign (including an abnormal laboratory finding), symptom, or disease temporally 
associated with the use of a medicinal (investigational) product, whether or not related to the 
medicinal (investigational) product. 
 
A serious adverse event (SAE) is any untoward medical occurrence that at any dose: 
• results in death 
• is life-threatening 
• requires inpatient hospitalisation or prolongation of existing hospitalisation 
• results in persistent or significant disability/incapacity, or 
• is a congenital anomaly/birth defect 
 
7.2 Collecting, Recording and Reporting of Serious Adverse Events (SAEs) to CIRB  
 
Only related SAEs (definitely/ probably/ possibly) will be reported to CIRB. Related means there 
is a reasonable possibility that the event may have been caused by participation in the clinical trial.  
Please refer to the CIRB website for more information on Reporting Requirement and Timeline 
for Serious Adverse Events.  
 
The investigator is responsible for informing CIRB after first knowledge that the case qualifies for 
reporting. Follow-up information will be actively sought and submitted as it becomes available.  
 
Related AEs will not be reported to CIRB.  However, the investigator is responsible to keep 
record of such AEs cases at the Study Site File. 
 
7.3 Collecting, Recording and Reporting of Serious Adverse Events (SAEs) to the 
Health Science Authority (HSA) 
 
All SAEs that are unexpected and related to the study drug will be reported to HSA. Please refer 
to the HSA website for more information on Safety Reporting Requirements for Clinical Trials.  
 

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7.4 Safety Monitoring Plan 
 
All data will be entered into a secure password-protected document in the desktop. Access to the data 
will only be open to the study investigators. Hardcopy of the data forms will be stored in a locked 
cupboard in the department. 
 
7.5 Complaint Handling  
 
If there is any complaint of the Mollii suit, the Principal Investigator will be informed immediately to 
rectify the issue. If the subject is unable to tolerate the Mollii suit, the study will be discontinued.  
 
8 
DATA ANALYSIS 
 
8.1 Data Quality Assurance 
 
The Principal Investigator will ensure accuracy of the data entered. Identifiable patient data will be 
anonymised. Access to the data will only be open to the investigators in the team. 
 
8.2 Data Entry and Storage 
 
All data will be entered into a secure password-protected document in the desktop. Access to the data 
will only be open to the study investigators. The Principal Investigator will ensure accuracy of the 
data entered. Hardcopy of the data forms will be stored in a locked cupboard in the department. 
 
9 
SAMPLE SIZE AND STATISTICAL METHODS 
 
9.1 Determination of Sample Size  
 
Sample size is determined based on a two-sided paired t-test at 80% power and significance level of 
0.05 to detect a minimal clinically important difference of 1.6 in Gait Profile Score with a standard 
deviation of 2.4 between pre- and post-intervention. 
 
9.2 Statistical and Analytical Plans 
 
Descriptive analysis of demographic and outcomes measures will be conducted. Mean, median, 
standard deviations, and proportions will be calculated to describe the samples.  
Sample size is determined based on a two-sided paired t-test at 80% power and significance level of 
0.05 to detect a minimal clinically important difference of 1.6 in Gait Profile Score with a standard 
deviation of 2.4 between pre- and post-intervention. 
 
10 DIRECT ACCESS TO SOURCE DATA/DOCUMENTS 
 
The investigator(s)/institution(s) will permit study-related monitoring, audits and/or IRB review and 
regulatory inspection(s), providing direct access to source data/document. 
 
 

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Page 17 of 19 
11 QUALITY CONTROL AND QUALITY ASSURANCE 
 
The principal investigator will ensure adherence with the protocol and accuracy in relation to data 
entry. Quality of the data will be ensured and monitored every month during the study period.   
 
The investigator will maintain essential study documents (protocol and amendments, source 
documentation, relevant correspondence, and all other supporting documentation) in a confidential 
manner as required by the approving ethics committee. 
 
 
 
12 ETHICAL CONSIDERATIONS 
 
This study will be conducted in accordance with the ethical principles that have their origin in the 
Declaration of Helsinki and that are consistent with the Good Clinical Practice and the applicable 
regulatory requirements. 
 
This final Clinical Trial Protocol, including the final version of the Participant Information Sheet 
and Consent Form, must be approved in writing by the Centralised Institutional Review Board 
(CIRB) and regulatory approval from Health Sciences Authority (HSA), prior to enrolment of any 
patient into the study. 
 
The principle investigator is responsible for informing the CIRB and HSA of any amendments to 
the protocol or other study-related documents, as per local requirement. 
 
12.1 Informed Consent 
 
In obtaining and documenting informed consent, the investigator will comply with the GCP 
guidelines and to the ethical principles that have their origin in the Declaration of Helsinki. 
Potential participant will be identified by therapist or doctor in KKH/and if inclusion criteria 
met, consent will be signed in the presence of a witness. Consent taking will take place in the 
clinic room or rehab outpatient room. The study investigator will sign the consent and make 
sure that study information is correctly given to the study participant. 
 
If the child has some but not full understanding of the Participant Information Sheet & Consent 
Form (attached to Section P6), (aged 6 and above), the simplified version (i.e. Child/ 
Participant Assent Form) will be used. If the child aged 13 and above, has sufficient 
understanding of the Participant Information Sheet & Consent Form, he will sign it with the 
parent co-signing in the legal guardian section. 
 
12.2 Confidentiality of Data and Patient Records 
 
All data will be entered into a secure password-protected document in the desktop. Identifiable 
patient data will be anonymised. Access to the data will only be open to the study investigators. 
Hardcopy of the data forms will be stored in a locked cupboard in the department. 

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Page 18 of 19 
 
13 PUBLICATIONS 
 
Study findings will be written up in a manuscript and published in a peer-reviewed journal. The 
publication policy will cover authorship, acknowledgments, and review procedures.  
 
 
14 RETENTION OF TRIAL DOCUMENTS 
 
When the study is completed, the research data will be kept in a secure password-protected document 
in the desktop at the department. All the documents will be retained for at least 7 years after 
completion of the research study. 
 
15 FUNDING and INSURANCE 
 
FUNDING AND RESOURCES  
In cash:  
Item 
Total 
Total cash needed for Gait 
Analysis x 20 subjects  
$62,960 
 
KKH Research Grant will cover SGD $34,988.  
Inerventions, Mollii will fund remaining SGD $27,972.  
 
In-kind contributions:  
KKH will supply the manpower for recruitment of study subjects and carrying out objective 
assessments and questionnaires for the study subjects.  
Mollii will supply up to 16 Mollii suit/ 10 control units for the participants during the study period. 
 
 
 
 
 

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Page 19 of 19 
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