The Feasibility and Impact of A Home-Based NMES Program on Post-Stroke Lower Limb Spasticity
Phase: NA
Conditions: Spasticity as Sequela of Stroke
Sponsor: University of Malaya

1 
 
 
 
 
 
 
 
RESEARCH PROPOSAL 
 
TITLE:  
THE FEASIBILITY AND IMPACT OF A HOME-BASED NMES PROGRAM ON POST-STROKE LOWER LIMB 
SPASTICITY 
 
Principle investigator 
:  
Dr. Raja Nabila binti Raja Mohamed Anuar 
Department of Rehabilitation Medicine, University of Malaya 
Medical  Centre 
 
Supervisor                        :  
Dr Chung Tze Yang 
                                           
Department of Rehabilitation Medicine, University of  Malaya 
Medical Centre 
 
Co-investigators 
:  
1. Pn Ida Mardiana binti Mohamad Yusop 
Physiotherapy Division, Department of Rehabilitation Medicine, 
University of Malaya Medical Centre 
 
 
 
 
 
2. Pn Wahida binti Wahid 
Physiotherapy Division, Department of Rehabilitation Medicine, 
University of Malaya Medical Centre 
 
Study site 
 
:  
University of Malaya Medical Centre (UMMC) 
Version  
 
:  
1.0 
Date 
 
 
:  
1st April 2020 
Time Frame 
 
: 
1st July 2020 – 30th September 2021 
 
 
 

2 
 
CONTENTS 
 
 
 
 
 
 
 
 
No 
Topic 
Page 
1 
LIST OF ABBBREVIATIONS 
3 
2 
ABSTRACT 
4 
3 
INTRODUCTION 
3.1 Research Area 
3.2 Research Questions 
3.3 Objectives 
3.4 Significance of study 
 
5 
5 
5 
6 
4 
LITERATURE REVIEW 
6 
5 
METHODOLOGY 
5.1 Study Design 
5.2 Setting  
5.3 Study Population  
5.4 Inclusion Criteria  
5.5 Exclusion Criteria 
5.6 Intervention, dose and mode of administration 
5.7 Outcome measures 
5.8 Sample Size 
5.9 Study Flow Chart  
5.10 Data Analysis  
 
10 
10 
10 
10 
10 
11 
11 
12 
12 
13 
6 
STRENGTH AND LIMITATIONS 
13 
7 
TIMELINE 
13 
8 
REFERENCES 
14 
9 
APPENDIX 
16 

3 
 
1. LIST OF ABBREVIATIONS 
 
PSS 
Poststroke spasticity 
UMMC 
University of Malaya Medical Centre 
NMES 
Neuromuscular Electrical Stimulation 
MAS 
Modified Ashworth Scale 
QoL 
Quality of Life 
PF 
Plantarflexors 
DF 
Dorsiflexor 
PC 
Pulsed Current 
PD 
Pulse Duration 
Hz 
Hertz 
s 
second 
mcs 
Microseconds 
SPSS 
Statistical Package For Social Science  
 
 
 
 

4 
 
2. ABSTRACT  
BACKGROUND: Spasticity is a common complication post stroke. Post-stroke spasticity along with 
weakness and lack of coordination result in gait abnormalities and problems with upper limb 
function. This affects stroke survival negatively on health-related QoL, affecting the caregiver and is 
a socioeconomic burden. Treatment options of spasticity includes physical therapy, ankle-foot 
orthosis, oral medications; chemodenervation with botulinum toxins, phenol, or alcohol; intrathecal 
baclofen, and surgical interventions. Recent treatment options include neuromuscular electric 
stimulation (NMES), a form of therapy that applies electrical currents to produce contraction of 
innervated muscle by depolarizing local motor nerves. Currently, there are wide varieties of devices 
delivering NMES, including battery-operated, portable devices. The purpose of this study is to 
evaluate the feasibility and acceptability of homebased NMES program on lower limb spasticity 
following stroke. We also like to assess the impact of the program to lower limb spasticity. To date 
there is no such research available in Malaysia.   
 
OBJECTIVES:  
1. To evaluate the feasibility and acceptability of home based NMES program. 
2. To assess the impact of home based NMES program in post stroke spasticity (spastic ankle 
plantarflexors) 
 
METHOD : Single arm prospective cohort intervention study. Participants are patients (post stroke 
>6months) with ankle plantarflexors spasticity Modified Ashworth Scale (MAS) 1+ to 3. Patient will 
receive homebased NMES for 20minutes, 5days a week for 4 weeks with stretching exercises while 
they resume their usual conventional rehabilitation program. NMES dose: Biphasic pulsed current, 
50Hz, pulse width 400µs, ON:OFF 10:20s with amplitude individual maximum tolerated to achieve 
ankle dorsiflexion, with electrodes at common peroneal nerve and motor point of tibialis anterior 
muscle. Patient will receive NMES treatment in sitting position with sole contact with the floor. 
Feasibility is determined by retention and compliance rates; acceptability by structured 
questionnaire at the end of study and the impact is determined by outcome measure of 
plantarflexors MAS, Modified Tardieu Scale, dorsiflexor strength and 10 meter walking test. 
 
 
 
 

5 
 
3. INTRODUCTION 
3. 1 Research Area 
Spasticity is a common complication post stroke. The prevalence of spasticity ranging from 19% at 3 
months post stroke to 46% at 12 months post stroke.1–3   Spasticity is defined as “a motor disorder 
characterized by a velocity-dependent increase in tonic stretch reflexes with exaggerated tendon 
jerks, resulting from hyperexcitability of the stretch reflex, as one component of the upper motor 
neuron syndrome”. 4  The impact of post stroke spasticity is substantial. Post-stroke spasticity along 
with weakness and lack of coordination, affects stroke survival negatively on the gait, functional 
activity and on the health-related quality of life (QoL). It also affects the caregiver on their QoL as 
increased care that the stroke survivor with spasticity requires, and it is a socioeconomic burden.5 A 
study in Sweden reported 4-fold increase in direct costs for patients with stroke with spasticity 
compared with patients with stroke without spasticity.6   
There are a number of treatment options for management of spasticity, including physical therapy; 
the usage of ankle-foot orthosis (AFO), oral medications; chemodenervation with botulinum toxins 
(BoNT), phenol, or alcohol; intrathecal baclofen therapy; and surgical interventions.7,8 More recent 
treatment options include neuromuscular electric stimulation (NMES).7–9   NMES refers to forms of 
therapy that apply electrical currents  to produce contraction of innervated muscle by depolarizing 
local motor nerves. Currently there are wide variety of devices deliver NMES, including battery-
operated, portable devices 10. However, NMES as a treatment of spasticity is not widely used in our 
local population. The purpose of this study is to evaluate the feasibility and acceptability of 
homebased NMES program on lower limb spasticity following stroke. We also like to assess the 
impact of the program to lower limb spasticity. To date there is no such research available in 
Malaysia.   
 
3.2 Research Questions 
1. Does home based NMES program is feasible and acceptable for patient with post stroke 
spasticity?  
 
2. Does home based NMES improve post-stroke spasticity of lower extremities (spastic ankle 
plantarflexors) assessed clinically and functionally (Modified Ashworth Scale (MAS), 
Modified Tardieu Scale and walking speed) ? 
 
3.3  Objective 
1. To evaluate the feasibility and acceptability of home based NMES program in post-stroke 
patient with spasticity. 
 
2. To assess the impact of home based NMES program in lower limb spasticity (spastic ankle 
plantarflexors) following stroke in direct clinical measurement and functionally.  
 
 

6 
 
3.4 Significance of this study 
1. This is first study in Malaysia that utilizes NMES for lower limb spasticity. The NMES devices are 
easily available commercially and relatively cheap. By conducting this study, we can assess the 
feasibility and patient’s perceptions of home-based NMES program for post-stroke population and 
will assist us in further prescription and management of post-stroke patient. 
2. It is homebased program. Formulating home-based rehabilitation protocol is substantial for 
rehabilitation medicine to provide better accessibility, maximize participation and empower patient-
driven rehabilitation.  Furthermore, with current trend (eg pandemic, logistic issue etc) patient 
preferred for less frequent hospital visitation; hence strengthening of home-based program is 
crucial. Thus, we can maintain rehab efficacy with reduced hospital visit and home program.  
3.  The result of this study will give us further knowledge on the usage of NMES and spasticity 
management. It enables healthcare professionals to decide on management of spasticity which is 
possibly less invasive, safe and more cost efficient.  
 
4.0 Literature review 
N 
Title, Author, year 
Type of study, sample 
size, Population and 
Methodology 
NMES parameters and outcome 
measures 
 
Result 
1. 
The feasibility 
and acceptability 
of neuromuscular 
electrical 
stimulation to 
improve exercise 
performance in 
patients with 
advanced cancer: 
a pilot study11 
 
Tamara Windholz, 
Tara Swanson, 
Brandy L 
Vanderbyl and R 
Thomas Jagoe. 
 
 BMC Palliative 
Care 2014 
 
 
Single arm prospective 
pilot study  
N 15-> 10(completed) 
 
Intervention: daily NMES 
at quadriceps  
 
Objectives: 
1) to evaluate the 
acceptability and 
feasibility of a home 
based NMES 
intervention in a patients 
attending the Cancer 
Nutrition-Rehabilitation 
Program 
clinic at the Jewish 
General Hospital (CNR-
JGH)  
 
2) To assess the impact 
of the NMES 
intervention on test of 
physical function. 
Frequency: 50 Hz,  
PD: 300 mcs  
On/off: 5s on 5 s off  
intensity was individually to 
obtain tetanic contraction or 
maximum tolerated intensity 
 
30min/d, 6 weeks 
 
Placement: at vastus medialis 
oblique distally,  
midpoint of quadriceps mm 
belly at proximal 
 
Outcome assessment 
1. Feasibility - proportion of pt 
who completed 6/52 
intervention, and overall level 
of adherence (40% cut-off) 
2. Acceptability NMES 
evaluated at the end of 6 weeks 
by questionnaire. 
3. Physical performance 
measures at baseline and at the 
end (PS, 6MWT, STC) 
 
The results of the pilot 
study suggest that 
NMES is both feasible 
and acceptable in a 
mixed group of 
patients with cancer, 
most of whom had 
poor performance 
status. 
 
Does not demonstrate 
that NMES leads to 
improved physical 
functioning in cancer 
patients with poor 
performance status, 
may be due to marked 
heterogeneity in terms 
of medical status and 
physical functioning; 
and small sample. 
2. 
Feasibility of 
neuromuscular 
electrical 
stimulation in 
critically ill 
patients12 
Prospective cohort study 
(N 50) 
 
To investigate the 
feasibility of NMES in 
eliciting a muscle 
NMES session for 20min during 
5 days per week + standard PT 
during the stay (positioning, 
chest PT, ROM and cycling in 
bed according to pt) 
 
Critically ill patients 
having sepsis, edema, 
or receiving 
vasopressors were less 
likely to respond to 
NMES with an 

7 
 
 
Johan Segers, PT, 
MSc a, Greet 
Hermans, MD, 
PhD b, Frans 
Bruyninckx, MD, 
PhD c, Geert 
Meyfroidt, MD, 
PhD d, Daniel 
Langer, PT, PhD a, 
Rik Gosselink, PT, 
PhD a 
 
Journal of Critical 
care, 2014 
 
contraction of the QF in 
critically ill patients and 
safety. 
NMES session is given in slowly 
increasing intensitiy and pulse 
duration in graded fashion to 
achieve favourable contraction 
(maximal 80mA and 500 mcs) 
 
Outcome measure: 
1) Feasibility --> 
Assessing responder 
(contraction 4-5) or non 
responder (contraction 1-3) and 
the factors affecting it: 
i- level of consciousness  
ii- Level of edema 
iii- Sepsis 
iv-medications 
 
2) Safety: 
cardioresp response (HR, BP, 
O2Sat, breathing) 
skin response 
 
 
adequate quadriceps 
contraction.  
 
Neuromuscular 
electrical stimulation is 
a safe intervention to 
be administered in the 
ICU. 
3. 
Does electrical 
stimulation 
reduce spasticity 
after stroke? A 
randomized 
controlled 
study13 
Amir H Bakhtiary 
and Elham 
Fatemy  
Clinical 
Rehabilitation, 
2008 
RCT 
N 40 (20 intervention, 20 
control) 
 
1) Bobath + NMES  
2) Control: Bobath  
Patient with ankle 
plantarflexor spasticity 
(does not mention 
duration post stroke) 
Faradic type PC 
Frequency 100Hz pulse 
stimulation PD: 100mcs,  
On:off 4:6, no ramp time 
supramaximal (25% over the 
intensity needed to produce 
maximum contraction of 
muscle) 
 
9 minutes daily  
For 20 session 
 
Electrodes: cathode on the 
tibialis anterior muscle via and 
anode over the fibula head 
 
Outcome measures: 
1) Passive ankle joint DF range 
of motion,  
2)DF strength test,  
3) PF muscle tone by Modified 
Ashworth Scale (MAS) 
4) soleus muscle H-reflex.  
 
Improvement were 
greater in treatment 
group: 
1) Lower PF spasticity 
(MAS) in combination 
group - 1.6  versus - 1.1 
in the Bobath group 
2) Higher ankle DF 
ROM in the 
combination group Vs 
in the Bobath group = 
11.4 vs 6.1 
3) Higher DF strength 
in combination group 
(0.7 vs 0.4) 
 
4. 
Functional 
electrical 
stimulation of 
dorsiflexor 
muscle: Effects 
on dorsiflexor 
strength, 
plantarflexor 
spasticity, and 
motor recovery 
Prospective 
interventional study.  
 
N 51 (27 intervention, 24 
control) 
 
1) Conventional rehab 
program (CRP) + EMS 
2)  CRP only 
 
Waveform NR 
Frequency 35Hz 
PD 280 mcs  
 
Stimulation timed to the gait 
cycle by using a heel switch 
placed in the shoe, causes ankle 
dorsiflexion in the swing phase 
of gait) 
 
Therapy combining  
EMS and conventional 
rehabilitation program 
was superior to a 
conventional 
rehabilitation program 
alone, in terms of: 
1) reducing spasticity, -
1.1 vs - 0.5 

8 
 
in stroke 
patients14 
 
Sukanta K. Sabut , 
Chhanda Sikdar , 
Ratnesh Kumar 
and Manjunatha 
Mahadevappa  
 
NeuroRehabilitati
on, IOP Press 
2011 
 
>3months post stroke 
with hemiplegia 
(unilateral drop foot) 
and able to walk at least 
10m without assistance. 
Not contracted. 
 
Amplitude set to produce 
muscle contraction within 
patient’s comfort. 
Duration: 20–30min 
5 days a week, for 12 weeks. 
Electrode: common peroneal 
nerve as it passes over the head 
of the fibula and the motor 
point of tibialis anterior. 
Outcome measures: 
1) PF spasticity measured by 
MAS 
2) DF strength 
3) Active/passive ankle joint 
dorsiflexion ROM 
4) Lower-extremity motor 
recovery by  FMA scale. 
@0 and week 12. 
 
2) improving DF ROM 
and strength  
3) lower extremity 
motor recovery in 
stroke patients.  
 
5. 
The effects of 
neuromuscular 
electrical 
stimulation on 
clinical 
improvement in 
hemiplegic lower 
extremity 
rehabilitation in 
chronic stroke: A 
single-blind, 
randomized, 
controlled trial15 
Nilgun Mesci, 
Ferda Ozdemir, 
Derya Demirbag 
Kabayel & Burcu 
Tokuc 
Disability and 
Rehabilitation 
2009 
RCT 
N 40 (20 intervention, 20 
control) 
 
Intervention: inpatient 
CRP + NMES 
Control: inpatient CRP 
Hemiparesis due to 
stroke >3 months, 
mobility of ankle to 
permit at least neutral 
position, MAS <4 
  
 
 
 
Biphasic PC wave 
Frequency 50 Hz  
Pulse width 400 mcs 
On:off: NR 
Intensity: fully contracted 
muscle without discomfort or 
pain.  
 
Duration 20min 
5 days, 4 weeks  
 
Pt position: sitting position and 
to keep their soles of their feet 
in contact with the floor. 
Electrode: positive active 
electrode right below the 
fibular head where the 
peroneal nerve is going 
through; and the negative 
electrode was positioned on the 
midpoint of the tibialis anterior 
muscle on the front side of the 
leg.  
Outcome measures: 
1. Ankle passive DF ROM  
2. Spasticity MAS  
3. Neurophysiological 
improvement in the 
lower extremities in 
Brunnstrom Stage (BS)  
4.  Functional 
Independence 
Measurement (FIM).  
Improvement were 
greater in treatment 
group in all outcome 
measures. 
1) ankle DF ROM (6.25 
vs 1.0) p=0.000 
2) decrease in the MAS 
-1.2 vs -0.15 (P=0.000) 
3) increase in the 
lower extremity BS 0.8 
vs 0.25 (p=0.005) 
4) improvement in the 
Rivermead leg and 
trunk scores p= 0.004) 
improvement in the 
FIM motor subscore (p 
=0.018)  

9 
 
5. Rivermead Motor 
Assessment Scale 
6. Functional Ambulation 
Categories (FAC)   
6. 
Transcutaneous 
Electrical Nerve 
Stimulation 
Combined With 
Task-Related 
Training 
Improves Lower 
Limb Functions in 
Subjects With 
Chronic Stroke16 
Shamay S.M. Ng, 
PhD; Christina 
W.Y. Hui-Chan, 
PhD  
2007 
 
 
single-blinded, stratified, 
randomized, controlled 
trial.  
N= 88 
 
4 groups: 
(1) TENS,  
(2) TENS  +TRT,  
(3) placebo TENS +TRT 
 (4) no treatment 
(control)  
 
1 year post stroke and 
able to walk 10 m 
unassisted with or 
without walking aids, 
and Composite Spasticity 
Score of at least 10 or 
more in their ankle PF 
(moderate spasticity) 
Square PC 
Frequency: 100Hz 
PD: 200mcs 
Intensity: 2 to 3 times sensory 
threshold 
 
Duration: 60minutes 
5 days a week for 4 weeks.  
Home program with 8 
outpatient sessions. 
 
Placement: 4 acupuncture 
points 
 
Outcome measurements: 
1) Composite Spasticity Scale,  
2) peak torque ankle 
dorsiflexors and plantarflexors 
recorded with a load cell 
mounted on a custom- built 
foot frame  
3) gait velocity (GAITRite)  
 
@ baseline, after 2 and 4 weeks 
of treatment, and 4 weeks after 
treatment ended  
 
Both TENS (TENS and 
TENS+TRT) groups 
showed earlier and 
significantly greater of 
reduction in PF 
spasticity as measured 
at week 2 
Combining TENS with 
TRT improved outcome 
measures significantly 
more than TENS alone, 
PLBO+TRT, or no 
treatment.  
Improvements can 
even be maintained 4 
weeks after treatment 
ended  
 
7.  
Effects of 
Electrical 
Stimulation in 
Spastic Muscles 
After Stroke 
Systematic 
Review and 
Meta-Analysis of 
Randomized 
Controlled Trials9  
Cinara Stein, MSc; 
Carolina Gassen 
Fritsch, Ft; 
Caroline 
Robinson, MSc; 
Graciele Sbruzzi, 
DSc; Rodrigo 
Della Méa Plentz, 
DSc  
American Heart 
Association, 2015 
Systematic review 
4 electronic databases 
(5066 titles) 
29 randomized clinical 
trials were included with 
940 subjects.   
→  UL and LL 
 
 
The primary outcome extracted 
was spasticity, assessed by the 
Modified Ashworth Scale, and 
the secondary outcome 
extracted was range of motion, 
assessed by Goniometer 
In this review, the 
usage of NMES with a 
frequency between 30 
and 50 Hz and a pulse 
width between 0.1 and 
0.5 ms for 30 minutes 
5 times per week for 3 
to 4 weeks were 
associated with 
successful results. 
 
 

10 
 
5. Methodology: 
 
5.1 Study Design  
 
Single arm prospective cohort intervention study. Patient with PSS recruited and will apply NMES to 
the lower limb at home in addition to their daily stretching exercises of their plantarflexion. They 
may also resume their conventional outpatient therapy session. 
 
5.2 Setting 
• 
Recruitment: Specialist clinic and therapy areas of Department of Rehabilitation Medicine, 
UMMC. 
• 
Intervention: Home setting 
 
5.3 Study population 
• 
Participants who are attending Rehabilitation Medicine Specialist clinics and therapy areas 
that fulfill the criteria will be screen for eligibility and recruited.   
• 
Demographics of participants including age, sex, race, dominant hand, etiology of stroke 
(ischemic/hemorrhagic), side of hemiparesis will be recorded.  
 
5.4 Inclusion criteria includes:  
• 
Post stroke (hemorrhagic or ischemic) with ankle plantarflexor (gastrocnemius and soleus) 
spasticity MAS 1+ to MAS 3 
• 
Post stroke more than 6 months  
• 
> 18 years old 
• 
Able to ambulate 10 meter either independently or aided (single point stick or quadripod) 
• 
Compliant to outpatient therapy. 
• 
Minimal cognitive (MMSE> 24) and minimal sensory impairment 
• 
Stable neurological and medical condition 
 
5.5 Exclusion criteria 
• 
Introduction or changes in anti-spastic medication dose within 3 months or during study 
period 
• 
Receiving intervention for spasticity (eg BoNT or serial casting) within 3 months or during 
research period. 
• 
New neurological condition/disease 
• 
Presence of contraindications to NMES, which is17: 
▪ 
Pregnancy 
▪ 
Malignancy 
▪ 
Presence of electronic implant eg cardiac pacemaker, cardioverter defibrillator 
▪ 
Uncontrolled seizure/epilepsy 
▪ 
Infected tissues/ tuberculosis or osteomyelitis 
▪ 
Impaired lower limb circulation/ DVT/ thrombophlebitis 

11 
 
▪ 
Recent fracture or osteoporosis 
▪ 
Actively bleeding tissue or person with untreated hemorrhagic disorder 
▪ 
Damaged or skin diseases at the affected lower limb 
 
 
5.6 Sample Size 
Consistent with the feasibility design, no formal sample size calculation was undertaken; rather a 
target sample of 20 participant was deemed sufficient to provide preliminary data required to 
test our feasibility study aim. 
  
Furthermore from literature review, Bakhtiary et al reported improvement of plantarflexor 
spasticity (MAS) in intervention group - 1.6 (SD 0.5) versus - 1.1 (SD 0.31) in control group. Thus 
the effect size is 0.75, and for an alpha of 0.05 and power of 0.8, sample size of 23 each arm is 
needed (not considering the attrition rate). 
 
5.7  Intervention, dose and mode of administration15:  
 
• 
It is a home-based NMES applications over the lower limb with plantarflexor spasticity using 
a commercially available consumer NMES machine. 
• 
Each patient will get a pair of new electrodes. 
 
• 
Dose of NMSE: 
▪ 
NMES waveform: biphasic PC 
▪ 
Frequency 50Hz, pulse width: 400µs, ON:OFF 10s:20s 
▪ 
Current amplitude: individual maximum tolerated to achieve ankle dorsiflexion. 
 
• 
Electrode placement (transcutaneous surface electrode): 
▪ 
1 electrode over the common peroneal nerve outlet (below the fibular head),  
▪ 
1 electrode over motor point of tibialis anterior or both tibialis anterior and peronei 
muscle. 
 
• 
Body and limb position: Patient sitting with the sole in contact with the floor, and try for 
active dorsiflexion during stimulation. 
 
• 
Duration: 20 minutes per session daily, 5 days a week, for 4 weeks (total 20sessions) 
 
• 
Compliant is monitored by daily logbook (Appendix 1) 
 
 
5.8 Outcome measures 
• 
Primary Outcome: 
 
1) Feasibility as assessed by proportion of patients who completed the program, and 
overall level of compliant  (retention and compliance rates) 
 
 
2) Acceptability as evaluated at the end of the intervention by brief structured 

12 
 
questionnaire developed for this study using 5 point Likert scale (Appendix 2) 
 
• 
Secondary Outcome: 
1) Clinical measurement of spasticity and functional outcomes: 
a. Modified Ashworth Scale (MAS)  
b. Modified Tardieu Scale (R1 R2 of ankle dorsiflexion) 
c. Ankle dorsiflexion muscle strength  
d. 10 meter walking test 
 
 
5.9 Study Flow Chart 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1) Screening - Inclusion/exclusion criteria application to patients attending Rehabilitation Medicine 
Specialist clinic and therapist area 
2) Consent - Explanation of study, Patient Information Sheet and Written Consent 
3) Pre-intervention assessment and familiarization session  
- Pre-intervention assessment per outcome measures (MAS, Modified Tradieu Scale, 
strength, and 10MWT) 
- Teaching patient (with or without family member) application of NMES  
- Trial of a 20 minutes session 
4) Intervention: Home-based NMES program for 4 weeks 
- A NMES device will be loaned to patient throughout the study period 
- A new pair of self-adhesive electrodes will be given to patient 
- Pre-setting NMES dose: Frequency 50Hz, pulse width: 400µs, ON:OFF 10s:20s 
- daily logbook 
5) Completion of intervention 
- Submission of logbook and NMES machine 
- post intervention assessment as per outcome measures (MAS, Modified Tradieu Scale, 
strength, and 10MWT) 
- Post intervention questionnaire 
 

13 
 
5.10 Data Analysis 
Data from this study will be analyzed using Statistical Package for Social Science (SPSS) software. 
• 
Comparison between participants who did and did not complete the study and the 
compliance rate will be performed using unpaired t-test and Fisher’s exact test for 
continuous and categorical variables respectively. 
• 
Improvement spasticity MAS (grading) – paired t-test 
• 
Improvement in ankle dorsiflexion ROM (degree) – paired t-test 
• 
Ankle dorsiflexion muscle strength (grading) – paired T-test 
• 
10 meter walking speed (ms-1) – paired t-test 
 
6.0 Strength and Limitation  
Strength 
• 
No previous published study in Malaysia looking at NMES application for reducing spasticity 
post- stroke. 
• 
Easily available equipment commercially and relatively cheap and safe. 
• 
Study conducted in stroke population therefore adequate number of samples can be 
recruited. 
 
Limitation 
• 
Resource and funding; it will be self-funded by main investigators.  
• 
Equipment handling and maintenance; risk of faulty equipment which could limit the 
research progress.  
• 
Single centre study 
 
7.0 Timeline 
Gantt Chart 
 
 
 

14 
 
8.0 References 
 
1.  
Sommerfeld DK, Eek EUB, Svensson AK, Holmqvist LW, Von Arbin MH. Spasticity after Stroke: Its 
Occurrence and Association with Motor Impairments and Activity Limitations. Stroke. 2004;35(1):134-
139. doi:10.1161/01.STR.0000105386.05173.5E 
2.  
Watkins CL, Leathley MJ, Gregson JM, Moore AP, Smith TL, Sharma AK. Prevalence of spasticity post 
stroke. Clin Rehabil. 2002;16(5):515-522. doi:10.1191/0269215502cr512oa 
3.  
Article CME. Upper-Limb Spasticity During the First Year After Stroke. 2014;93(10):884-896. 
doi:10.1097/PHM.0000000000000157 
4.  
Feldman, young K. Lance JW. Symposium Synopsis. In: Feldman RG, Young R, Koella WP, Eds. Spasticity: 
Disordered Motor Control. Chicago, IL: Year Book Medical Publishers; 1980:485–494.; 1980. 
5.  
Zorowitz RD, Gillard PJ, Brainin M. Poststroke spasticity: Sequelae and burden on stroke survivors and 
caregivers. Neurology. 2013;80(3 SUPPL.2). doi:10.1212/wnl.0b013e3182764c86 
6.  
Lundström E, Smits A, Borg J, Terént A. Four-fold increase in direct costs of stroke survivors with 
spasticity compared with stroke survivors without spasticity: The first year after the event. Stroke. 
2010;41(2):319-324. doi:10.1161/STROKEAHA.109.558619 
7.  
Francisco GE, McGuire JR. Poststroke spasticity management. Stroke. 2012;43(11):3132-3136. 
doi:10.1161/STROKEAHA.111.639831 
8.  
Jacob A, Wilkenfeld L. Review of electrical stimulation, botulinum toxin, and their combination for 
spastic drop foot. 2013;50(3):315-326. 
9.  
Stein C, Fritsch CG asse., Robinson C, Sbruzzi G, Plentz RD ell. M. Effects of Electrical Stimulation in 
Spastic Muscles After Stroke: Systematic Review and Meta-Analysis of Randomized Controlled Trials. 
Stroke. 2015;46(8):2197-2205. doi:10.1161/STROKEAHA.115.009633 
10.  
Nussbaum EL, Houghton P, Anthony J, Rennie S, Shay BL, Hoens AM. Neuromuscular electrical 
stimulation for treatment of muscle impairment: Critical review and recommendations for clinical 
practice. Physiother Canada. 2017;69(5 Special Issue):1-76. doi:10.3138/ptc.2015-88 
11.  
Windholz T, Swanson T, Vanderbyl BL, Jagoe RT. Erratum: The feasibility and acceptability of 
neuromuscular electrical stimulation to improve exercise performance in patients with advanced 
cancer: A pilot study (BMC Palliative Care (2014) 13 (33)). BMC Palliat Care. 2014;13(1):1-8. 
doi:10.1186/1472-684X-13-33 
12.  
Segers J, Hermans G, Bruyninckx F, Meyfroidt G, Langer D, Gosselink R. Feasibility of neuromuscular 
electrical stimulation in critically ill patients. J Crit Care. 2014;29(6):1082-1088. 
doi:10.1016/j.jcrc.2014.06.024 
13.  
Bakhtiary AH, Fatemy E. Does electrical stimulation reduce spasticity after stroke? A randomized 
controlled study. Clin Rehabil. 2008;22(5):418-425. doi:10.1177/0269215507084008 
14.  
Sabut SK, Sikdar C, Kumar R, Mahadevappa M. Functional electrical stimulation of dorsiflexor muscle: 
Effects on dorsiflexor strength, plantarflexor spasticity, and motor recovery in stroke patients. 
NeuroRehabilitation. 2011;29(4):393-400. doi:10.3233/NRE-2011-0717 
15.  
Mesci N, Ozdemir F, Kabayel DD, Tokuc B. The effects of neuromuscular electrical stimulation on 
clinical improvement in hemiplegic lower extremity rehabilitation in chronic stroke: A single-blind, 
randomised, controlled trial. Disabil Rehabil. 2009;31(24):2047-2054. 
doi:10.3109/09638280902893626 
16.  
Ng SSM, Hui-Chan CWY. Transcutaneous electrical nerve stimulation combined with task-related 
training improves lower limb functions in subjects with chronic stroke. Stroke. 2007;38(11):2953-2959. 
doi:10.1161/STROKEAHA.107.490318 

15 
 
17.  
Rennie S. ELECTROPHYSICAL AGENTS - Contraindications And Precautions: An Evidence-Based Approach 
To Clinical Decision Making In Physical Therapy. Vol 62.; 2010. doi:10.3138/ptc.62.5 
18.  
Kondo T, Yamada S, Tanimura D, et al. Neuromuscular electrical stimulation is feasible in patients with 
acute heart failure. ESC Hear Fail. 2019;6(5):975-982. doi:10.1002/ehf2.12504 
 
 
 

16 
 
Appendix 1 
Patient’s Feedback Questionnaire 
R/N:………………………………………………… 
 
 
 
 
Date:…………………………….. 
 
 
General acceptability and satisfaction 
1= 
Strongly 
Disagree 
2 = 
Disagree 
3 = 
Neutral 
4 = 
Agree 
 
5 = 
Strongly 
Agree 
1. 
Using the NMES for 4 weeks is acceptable 
 
 
 
 
 
 
2. 
Using NMES for 20 minutes a day is acceptable 
 
 
 
 
 
3 
Using NMES had a positive impact on my lower  
limb spasticity 
 
 
 
 
 
4. 
Using NMES had a positive impact on my 
ambulation 
 
 
 
 
 
5. 
I would continue/repeat the NMES program after 
the study 
 
 
 
 
 
6. 
I would recommend this program to my 
colleagues/other patients 
 
 
 
 
 
7 
Overall, I think the homebased NMES program is a 
good intervention 
 
 
 
 
 
8. 
I would consider buying the device if the price is 
affordable 
 
 
 
 
 
 
 
 
Device’s operation experiences. 
1= 
Strongly 
Disagree 
2 = 
Disagree 
3 = 
Neutral 
4 = 
Agree 
 
5 = 
Strongly 
Agree 
9. 
The NMES device is simple to use 
 
 
 
 
 
10. 
Most of the time I can handle the device 
independently. 
 
 
 
 
 
11. 
It is easy to put on the surface electrode to the 
lower limb. 
 
 
 
 
 
15. 
I can use the surface electrode independently 
 
 
 
 
 
 
 
While using the NMES, I have experience…. 
1= 
Never 
2 = 
Rarely  
3 = 
Sometimes 
4 = 
Often 
 
5 = 
Always 
16 
Pain 
 
 
 
 
 
17 
Discomfort 
 
 
 
 
 
18 
Skin irritations/ burns 
 
 
 
 
 
19 
Muscle fatigue 
 
 
 
 
 
20 
Others: 
 
 
 
 
 
 
Do you have any other comment or concern? 
__________________________________________________________________________________
__________________________________________________________________________________ 
 
 

17 
 
Appendix 2 
HOME-BASED NMES PROGRAM LOG SHEET 
 
Name: _____________________________________________________ 
RN/ IC: _______________________________ 
Period: ____________to _________________ 
 
Week 1:  
No Date 
Time start 
Time end 
NMES intensity 
Stretching  
Notes 
1. 
 
 
 
 
 
 
2. 
 
 
 
 
 
 
3. 
 
 
 
 
 
 
4. 
 
 
 
 
 
 
5. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Outpatient therapy session: Yes/ No 
Date: 
Time: From ____________to _____________ 
Place: 
 
 
Week 2 
No Date 
Time start 
Time end 
NMES intensity 
Stretching  
Notes 
1. 
 
 
 
 
 
 
2. 
 
 
 
 
 
 
3. 
 
 
 
 
 
 
4. 
 
 
 
 
 
 
5. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Outpatient therapy session: Yes/ No 
Date: 
Time: From ____________to _____________ 
Place: 
 
 

18 
 
Week 3 
No Date 
Time start 
Time end 
NMES intensity 
Stretching 
Notes 
1. 
 
 
 
 
 
 
2. 
 
 
 
 
 
 
3. 
 
 
 
 
 
 
4. 
 
 
 
 
 
 
5. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Outpatient therapy session: Yes/ No 
Date: 
Time: From ____________to _____________ 
Place: 
 
Week 4 
No Date 
Time start 
Time end 
NMES intensity 
Stretching  
Notes 
1. 
 
 
 
 
 
 
2. 
 
 
 
 
 
 
3. 
 
 
 
 
 
 
4. 
 
 
 
 
 
 
5. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Outpatient therapy session: Yes / No 
Date: 
Time: From ____________to _____________ 
Place: