The Impact of an Evidence-Informed Spinal Cord Injury Activities of Daily Living Educational Manual (SADL-eM): Study Protocol for a Randomized Clinical Trial
Phase: NA
Conditions: Spinal Cord Injuries
Sponsor: University of Stellenbosch

 
 
 
 
The Impact of an Evidence-Informed Spinal Cord Injury Activities of Daily Living 
Educational Manual (SADL-eM): study protocol for a randomized clinical trial 
 
 
 
NCT number: not available 
 
 
26.01.2021 
 

The Impact of an Evidence-Informed Spinal Cord Injury Activities of Daily Living 
Educational Manual (SADL-eM): study protocol for a randomized clinical trial 
 
1. Moussa Abu Mostafa, Faculty of Medicine and Health Sciences, Division of 
Occupational Therapy, Stellenbosch University, RSA. 
2. Nicola Ann Plastow, Faculty of Medicine and Health Sciences, Division of 
Occupational Therapy, Stellenbosch University, RSA. 
3. Maggi Savin-Baden, School of Education, University of Worcester, UK. 
4. Birhanu T. Ayele, Division of Epidemiology and Biostatistics, Faculty of Medicine 
and Health Sciences, Stellenbosch University, RSA. 
 
Corresponding author: Moussa Abu Mostafa, Occupational Therapy Ph.D. student, 
Stellenbosch University, moussaabumostafa@gmail.com. 
Corresponding author address: Department of Medicine and Health Sciences, Division of 
Occupational Therapy, Private Bag X1, Matieland, 7602, Stellenbosch, South Africa. 
Abstract 
Background: This study argues that providing evidence-based occupational therapy patient 
education is vital in order to optimize rehabilitation outcomes. The planned trial aims to 
evaluate the SADL-eM intervention for people with SCI compared with standard treatment. 
Methods/Design: This is a parallel randomized clinical trial with two study arms, 
intervention and control. Ninety patients treated in inpatient rehabilitation settings will be 
randomly allocated to two study groups. Both groups will receive standard care. The 
intervention group will also receive a copy of the SADL-eM from their treating occupational 
therapist during an individual session. Assessment on admission (baseline measure) and after 
six weeks of admission will use the SCIM-SR as the primary outcome measure. Secondary 
outcomes include the SCIM-III, Private Religiousness Practices Scale, Organizational 
Religiousness Short-Form, additional domains of ADL covered by the educational manual 
and adherence to intervention. Effect will be determined using repeated measures ANOVA. 
Discussion: The SADL-eM is a comprehensive ADL educational tool that aims to optimize 
rehabilitation outcomes for people with SCI. If the SADL-eM is demonstrated as clinically 
effective, this will have significant implications for occupational therapy interventions in 
LMIC settings. 

 
Trial registration: BLINDED FOR REVIEW (Project ID: 1635, HREC Reference 
number: S17/10/206). Helsinki Committee for Ethical Approval (PHRC/HC/689/20) 
Date of registration: 30/11/2017, Renewed 12/06/2020 
Keywords: Occupational therapy, educational intervention, Activities of daily living, Spinal 
Cord Injury, clinical trials 
Introduction 
Patient education is gaining more interest especially during the time of COVID-19 (Wasson, 
2020). People with SCIs requiring inpatient rehabilitation in the Gaza Strip complete their 
medical management in a secondary healthcare facility and arrange for subsequent referral and 
admission to an inpatient rehabilitation setting. Due to limited resources, many patients are 
added to waiting list before admission. Providing functional therapy and health education as 
the main objectives of inpatient rehabilitation for people with spinal cord injury in Low and 
Middle Income Countries (LMIC) is being limited by shorter length of stay (LOS) in inpatient 
rehabilitation settings and inadequate community rehabilitation. Some inpatients are being 
discharged home with less skills in Activities of Daily Living (ADL), mobility, and prevention 
of medical complications. These challenges increase the demand for evidence based 
educational interventions including ADL education during inpatient care, that improves 
rehabilitation outcomes (Mostafa, Plastow, and Savin-Baden, 2019). 
SCI patient education aims to develop knowledge, skills, attitudes, and behaviors to maintain 
health and wellbeing, prevent secondary complications, and enhance active life participation 
(Mostafa, et al., 2019). Topics presented early in the admission phase may include body 
anatomy and functioning, while others like community integration can be presented at later 
phases of rehabilitation so that SCI individuals will become progressively independent in 
activities of daily living (Letts et al., 2011). 
An effective SCI educational manual should be accessible and motivating in terms of 
information, details, and layout. It should provide support, for example web groups, 
consultations, and answers to common questions. An SCI educational manual must also be 
cost-effective, up-to-date and meet the needs of people from different backgrounds, 
preferences, genders and ethnicities (Chou, et al., 2012). It is important that SCI educational 
manuals targeting adults provide autonomy and are guided by adult learning theory to facilitate 
active roles of people with SCI (May, Day, and Warren, 2006). Staff availability (time allocated 

for patient education) and patient readiness (motivation and interest) are two important 
concerns for effective patient education. Time allocated for patient education can be limited 
and inadequate due to patient treatment workload and staffing shortages. Decreased motivation 
and interest of the patient during rehabilitation adds another barrier to patient education 
(Shepherd, et al., 2012).  
This study plans to evaluate the impact of providing an evidence-informed SCI ADL 
educational manual (SADL-eM) on activities of daily living among people undergoing 
rehabilitation for a spinal cord injury in the Gaza Strip, Palestine. This study may counter the 
effect of decreased LOS in rehabilitation in this LMIC context. By improving patient education, 
the authors intend to improve patients’ involvement in their treatment during their stay in the 
three inpatient rehabilitation settings available in the Gaza Strip. An effective educational 
intervention will enhance the quality of care and reduce the cost of healthcare services in the 
long term.  
This aim of the proposed study is to evaluate the impact of a SADL-eM on activities of daily 
living. This educational intervention is delivered to inpatients with SCI in a rehabilitation 
setting. 
Research question 
Does the implementation of a SADL-eM delivered to SCI patients in an inpatient rehabilitation 
setting in the Gaza Strip have a significant impact on activities of daily living? 
Primary objectives 
a. To describe the characteristics of the participants (people with SCI in the Gaza Strip 
using the Biographical Data Form developed for this study). 
b. To compare the effect of the educational manual, relative to usual care, on self-
reported changes in activities of daily living from admission to 6-weeks post-
admission, using the SCIM-SR patient-rated measure. 
c. To compare the effect of the educational manual, relative to usual care, on observed 
changes in activities of daily living from admission to 6-weeks post-admission, using 
the SCIM-III clinician-rated measure. 
d. To compare the effect of the education manual, relative to usual care, on religious 
practice using the Private Religiousness Practices Scale and Organizational 
Religiousness Short-Form. 

e. To compare the effect of the education manual, relative to usual care, on the domains 
of ADL covered by the education manual including driving and community mobility, 
personal device care, health management and maintenance, Wudu, and Salat, using 
questions developed for this research. 
Secondary objectives 
f. To determine the significance of biographical variables (Address zone, Age, Gender, 
Highest level of Education, Marital status, Employment status, Monthly income, Level 
of SCI, Type of SCI ‘complete/incomplete’), ASIA, and Dysfunction on the progress 
of ADL. 
g. To measure the adherence to the intervention using the SADL-eM adherence therapist-
report questionnaire which will be developed for this purpose. 
Research Hypothesis 
a. Null hypothesis: There is no difference between the SADL-eM and the standard care 
delivered to inpatients with SCI in a rehabilitation setting. 
b. Alternative hypothesis: The implementation of a SADL-eM delivered to inpatients 
with SCI in a rehabilitation setting has a significant impact on their ADL. 
Methodology  
Study Design  
Please insert Figure 1 (Study Flow Diagram) here 
This is a parallel, single blinded (assessor) randomized clinical trial (RCT) with a pre-/post-
test to evaluate a hypothesis of cause-and-effect relationship. This study uses the Consolidated 
Standards of Reporting Trials (CONSORT) statement as the proposed standard for the 
reporting of parallel-group RCTs (Moher et al., 2010). 
Participants, sampling method, sample size, and setting 
Participants in the study will be SCI inpatients from the Gaza Strip, both genders, of any cause 
or type of SCI, and age 18-65 years. They will be recruited from admitted inpatients in one of 
the three rehabilitation settings (Hamad, ElWafa, or ElAmal Rehabilitation hospitals). 
Readmissions will be included in the study if they are eligible. These three inpatient 
rehabilitation hospitals are located in the Gaza Strip of Palestine and are private sector health 
services. They provide comprehensive rehabilitation services. Their rehabilitation teams 
include physical rehabilitation doctors, rehabilitation nurses, physiotherapists, occupational 

therapists, speech therapists, clinical dietitians, psychologists, social workers, orthoptists, and 
community-based rehabilitation workers. The sample size was determined to detect an effect 
size of 15%, power of 80%, 5% margin of error, and 95% Confidence Interval (CI). The study 
sample of 90 SCI individuals will be randomized to two groups, conventional therapy (n1=45) 
and intervention/SADL-eM & conventional therapy (n2=45) using a simple randomization 
approach. Inclusion and exclusion criteria are listed in Box 1. 
Please insert box 1 (inclusion and exclusion criteria) here 
Pilot study 
Pilot studies are small-sample, preliminary studies which aim to investigate the feasibility of a 
study. RCTs usually use pilot studies to improve feasibility and avoid crucial barriers (Bell, 
Whitehead, and Julious, 2018). A small number (15) of participants with SCI of any cause and 
of any type aged 18-65 years with a previous inpatient rehabilitation experience will take part 
in the pilot study. They will be selected from the 2019-2020 inpatient list of Hamad 
Rehabilitation Hospital. They will complete the Spinal Cord Independence Measure-Self 
Reported (SCIM-SR). A well-trained research assistant (physiotherapist) will administer the 
biographical data collection tool, the Spinal Cord Independence Measure-III (SCIM-III), the 
Private Religiousness Practices Scale, Organizational Religiousness Short-Form, and the 
domains of ADL covered by the educational manual including driving and community 
mobility, personal device care, health management and maintenance, Wudu, and Salat. The 
patients and the research assistant will comment on the tools employed and point out any 
problems with the tests’ instructions, instances where items are not clear, and formatting and 
other typographical errors and/or issues. Each question measures performance/participation in 
ADL will be analyzed using the Cronbach’s Alpha to test and improve reliability. 
SCI ADL Educational Manual (SADL-eM) 
Both study groups will receive usual care. In addition, each participant in the experimental 
group will receive a copy of the SADL-eM from their occupational therapist with a short 
discussion about its importance and use. 
The SADL-eM was developed by the authors following a systematic review (BLINDED FOR 
REVIEW) and user-led development project. A team of 54 Subject Matter Experts (SME) 
collaborated in a Participatory Action Research (PAR) project to develop the manual. The 
researchers used eight consecutive focus groups and Nominal Groups Technique (NGT) for 

consensus. The manual production took 17 months and is to our knowledge the first 
comprehensive SCI ADL educational tool available in Arabic. 
The SADL-eM includes three elements essential to the intervention, namely: knowledge, skills, 
and advice. The manual includes 92 A5 pages with six detailed sections: an Introduction and 
five chapters: (1) Rehabilitation team, (2) Activities of Daily Living, (3) Assistive devices, (4) 
Home environment adaptation, and (5) Knowledge guide. The SADL-eM uses text and 
illustrative pictures that are carefully selected for contextual relevance. The manual is simple, 
easy, and suitable for people with a non-medical background. However, good Arabic language 
comprehension, read and write is mandatory for users. No other special skills or experience are 
required. 
The purpose of the SADL-eM is to serve as a treatment tool during inpatient rehabilitation. 
Over the first week of admission of each person with SCI in each facility, a research clinical 
supervisor will recruit study participants based on the study eligibility criteria, obtain consent, 
and assign each consenting patient to one of the two study groups. They will then provide each 
participant in the intervention group with a SADL-eM hard copy, and explain the purpose of 
the manual and how to use it. The manual will be reviewed by the treating occupational 
therapist and the person with SCI during their treatment sessions. During occupational therapy 
sessions, the therapist will refer to the relevant chapter of the manual. The therapist will also 
indicate to the participants which parts of the manual are not relevant to them (based on their 
gender, driving status, or level of SCI). Participants’ queries on the content of the manual will 
be answered by the treating occupational therapist. The therapist will include the manual in as 
many SADL-eM educational sessions as required, but not less than three sessions per week 
with 15 minutes per session. The minimum level of clinical experience of each treating 
occupational therapist will be two years. Good Arabic language comprehension, and the ability 
to read and write is mandatory for both therapists and patients. No other special skills or 
experience are required. 
The participants will keep the manual to review after sessions and after discharge from the 
inpatient rehabilitation setting. For the purposes of the study, blinding and bias reduction, the 
therapists and the participants in the intervention group must not share any part of the manual 
or information included with other patients or staff. The research assistant who performs data 
collection, the clinical supervisor, and occupational therapy team will be invited for 
informational session prior to data collection in each of the participating settings. The 
informational session will focus on the study purpose, recruitment, eligibility criteria, use of 

the SADL-eM, roles, bias reduction, and blinding. Use of data collection tools will take place 
in a separate session with the research assistant. The principal researcher will answer all 
questions of the research team during informational sessions and during the research. 
For the purposes of the current study, the SADL-eM will be provided during face-to-face 
individual occupational therapy sessions without any constrains regarding treatment area. It 
could be occupational therapy department, patient ward, and educational activities room. The 
face-to-face manual delivery does not require any infrastructure or special equipment. 
The number of sessions, time allocated, and frequency are determined by each therapist and 
participant. Determinants may include participant’s capabilities, potentials, and progress 
during treatment; and the scope of the service such as time allocated for each patient, therapist-
patient ratio, and frequency of inpatient sessions. The therapist and the participant will continue 
to use the manual during treatment sessions until they decide there is no need for further use of 
the manual or the participant is discharged. Treating occupational therapists will retain records 
of any change or modification of the SADL-eM administration. The researchers will conduct 
a pilot study in a similar sample of 15 S people with SaCIs to improve the use of intervention 
and data collection tools. 
Nonadherence to medical treatment in clinical trials of medical efficacy has serious 
consequences on the quality of research. It may obscure data collected and disrupt findings 
obtained (Quittner, et al., 2000). The steps to ensure adherence to the intervention during study 
include clearly defining the intervention, measuring, and then comprehensively reporting 
adherence to the intervention. Attendance records collected by the therapist (times, duration, 
and intensity of treatment; manual elements covered) and SADL-eM adherence therapist-report 
questionnaire will be used to measure and report adherence to the SADL-eM intervention. The 
manual will be made freely available on the Stellenbosch University website when the research 
is complete. 
Data Collection 
All admitted SCI patients will be evaluated by the research supervisor in the setting for 
eligibility within three days of admission to the inpatient rehabilitation setting, until the desired 
sample size is reached. Eligible individuals will sign a consent form and then be assigned 
randomly to one arm of the study by the research supervisor. The allocation sequence will be 
concealed from patients, therapist and, assessor. The data about exposure to the educational 
intervention will be collected by a separate research assistant by phone and will be concealed 

from the assessor. Each occupational therapy department will assign four therapists to follow 
up the trial cases – two for the intervention and two for control group. All the staff in the 
occupational therapy department, participants, and assessors will be requested not to discuss 
the trial and intervention material between them. The importance of concealing any information 
until the end of the study will be explained. Study participants are not allowed to switch 
between occupational therapists or study arms. They will be asked not to participate in other 
educational interventions (peer or external) related to their rehabilitation or seek treatment 
outside their trial. The head of occupational therapy department within each rehabilitation 
setting will supervise participants and assigned occupational therapists in both study arms to 
reduce contamination bias such as sharing intervention content with the control group, sharing 
similar time and space of occupational therapy sessions, and exchange of therapists. 
Contamination bias due to already existing background and/or receipt of additional educational 
interventions will be measured within each arm of the study (Chi-Square test to compare the 
progress means). However, no case will be eliminated from statistical analysis due to 
contamination bias. 
The study will adopt approaches to prevent loss of participants to follow-up by making 
questionnaires as easy to complete as possible, providing incentives in the form of a free copy 
of the educational manual for the control group, and explaining the importance of the study 
(Magill, et al., 2019). 
The researchers will use the same outcome measures all through the study and with both of 
study arms. Biographical data will be collected by a research assistant once on the participant’s 
admission and consent to participate. ADL data collection from each participant in the study 
will take place in a face-to-face interview twice (on admission before providing with the 
educational manual and 6 weeks later) using: (a) Patient-administered SCIM-SR and (b) 
Research assistant-administered SCIM-III, the Private Religiousness Practices Scale, 
Organizational Religiousness Short-Form, and the domains of ADL covered by the educational 
manual including driving and community mobility, personal device care, health management 
and maintenance, Wudu, and Salat. The data will be used to compare the results and means of 
both groups, answer the research question, and test the study hypothesis. 
Polit, et al. (2001) pointed out that the validity of the experimental study can be threatened by 
history, selection, and maturation. This study finding’s validity will be enhanced by concealing 
intervention group using a blinded assessor. The bias of sampling and contamination will be 

minimized through randomization and assuring freedom of participation and anonymity of 
participants. 
Objective data collected in clinical settings using valid and reliable tools is essential for 
evaluating the impact of an intervention (Polit, et al., 2001). The validity and reliability of the 
data collected and results of the study will be improved using standardized measurement tools 
such as SCIM-III and SCIM-SR. 
Biographical Data Collection Tool: an English 24-item tool that captures demographic and 
socioeconomic data including age, gender, marital status, level of education, employment, 
monthly income, accommodation, diagnosis, and cause and type of SCI. The researchers 
developed the tool to be used in English version in this study. 
Spinal Cord Independence Measure-Self Reported (SCIM-SR): a patient-reported 17-
item tool that evaluates the ability of a person with SCI to perform specified activities 
independently, with assistance, or with assistive devices. The tool uses an ordinal scale. 
Research supports the criterion validity of SCIM-SR as compared with SCIM III. Pearson 
correlation and ICC coefficients of the total and the subscale scores met the quality criterion 
of being above 0.7. The tool is not available in Arabic (Fekete, et al., 2013). The first author 
will translate the SCIM-SR to Arabic. The Arabic translation will be piloted in the pilot 
study. 
Spinal Cord Independence Measure-III (SCIM-III): a 17-task tool that evaluates the 
ability of a person with SCI to perform specified activities independently, with assistance, or 
with assistive devices. It is therapist-reported and requires 30 to 45 minutes to complete by 
assessment but, the interview requires less time [about 20 minutes] (Fekete, et al., 2013). The 
SCIM has been evaluated in multiple countries including the Middle East and it appears to be 
resistant to cross-cultural differences. The SCIM-III is valid for use in clinical practice to 
evaluate function and plan goals of rehabilitation (Glass, et al., 2009). The tool uses an 
ordinal scale with total score range between 0-100. A higher score indicates greater ADL 
performance. The SCIM-III has good reliability: Cronbach’s alpha: 0.70-0.78, Kappa co-

efficient: 0.64-0.84. Pearson correlation and ICC coefficients of the total and the subscale 
scores met the quality criterion of being 0.84-0.94. The tool is not available in Arabic and 
will be used in its English version (Anderson, et al., 2008). Good English language 
comprehension, and the ability to read and write is mandatory for therapists. 
The Private Religious Practices Scale: a 4-item tool that measures the frequency of 
individual’s involvement in religious behaviours: prayer, religious attendance (attending a 
church or mosque), reading the Bible/Quran, and watching religious programs on television 
(Fetzer Institute, 2003). The tool uses an ordinal scale and it has acceptable reliability 
(a=0.70). It can be therapist-reported or patient-reported. The tool is not available in Arabic 
and will be used in its English version (Bodling, et al., 2013). 
Organizational Religiousness Short-Form: a 2-item tool that measures the involvement of 
the individual with a formal public religious institution such as a church or mosque (Fetzer 
Institute, 2003). The tool uses an ordinal scale and has accepted reliability (a=0.70-0.76). It 
can be therapist-reported or patient-reported. The tool is not available in Arabic and will be 
used in its English version (Bodling, et al., 2013). 
SADL-eM adherence therapist-report questionnaire: Based on the Morisky Medication 
Adherence Scale [MMAS] (De las Cuevas and Penate, 2015), this tool measures any change 
to the supplied SADL-eM in terms of content of the intervention, topics, techniques described, 
mode, format, and degree of individualization of the intervention. The tool keeps record of 
educational sessions by day, duration, intensity, and elements covered. This tool was developed 
by the researchers and will be used in its English version. 
Monitoring 
The three researchers will monitor the study on monthly bases during online meetings. 
Progress, barriers, and action plans will be discussed at each meeting. 
Data Analysis 
 

Captured data will be coded and reviewed by the researchers for clarity and completion. A 
spread sheet will be prepared by the three researchers and then loaded to IBMSPSS 21 for 
analysis. The first author will perform data entry. The research assistant will check the data 
entry using the original forms, and the research supervisor will check the data for missing data 
and entry errors. 
The following statistical methods will be used to test the research hypothesis: 
a. To describe participants’ characteristics: descriptive statistics such as frequency, 
percentage, mean with standard deviation for Normally distributed data and median and 
Inter Quartile range will be used for continuous variables that are not Normally 
distributed will be used. 
b. Missing values will not be substituted. Intention-to treat analysis method will be used 
for analysis. 
c. To determine the significance of biographical variables at baseline: McNemar and Chi 
Square with Nominal variables, T-test and Mann-Whitney for interval variables will be 
used. 
d. To compare the efficacy of the educational manual: Repeated Measures ANOVA/ 
Linear Mixed Models will be used will be used to assess differences between 
intervention and control group using the ADL data. The Repeated Measures ANOVA 
and Linear Mixed Models will be used to analyze the data. Linear Mixed Models has 
advantage in dealing with missing values and provides fixed and random effect 
(Krueger and Tian, 2004). 
e. Adherence to the intervention will be summarized using frequency and percentage. 
All the data collected and entered (hardcopy and soft copy) will be securely stored by the first 
researcher in a locked cabinet on hospital premises (hardcopy) and in a password-protected file 
online. 
Ethical Issues 
Ethical approval will be obtained from the BLINDED University Human Research Ethics 
Committee (HREC). Autonomy of participation or withdrawal, the anonymity of participants, 
and confidentiality of information collected for research reasons will be assured in the consent 
form and sustained all through study. The study is unlikely to involve any harm, risk or 
discomfort to participants. Patients' questions will be answered by the researcher honestly and 
as fully as possible. Completed questionnaires and signed consents of participants will be 

securely stored during and after study completion in a locked cabinet on hospital premises for 
a period of 5 years after publication. The participants in the control group will receive a copy 
of the SADL-eM at the end of study with explanation from the researcher. 
Protocol amendments 
The researchers will communicate important protocol modifications such as changes to 
eligibility criteria, outcomes, and analyses to HREC of BLINDED University under the 
regulations of the Helsinki Declaration. 
Access to data 
Anonymized data will be available for peer review or quality appraisal. Any other data sharing 
will require the approval of the three researchers, as well as ethical approval from the requesting 
party. 
Dissemination policy 
The study manuscript will be submitted for publication in a relevant peer-reviewed journal, 
and further dissemination through conference presentations. The SADL-eM will be made 
freely available on the XX University website in Arabic, with a summary in English. 
COVID-19 precautions 
The treating occupational therapists and research assistant will follow the required COVID-19 
precautions published by the WHO (DiSilvio, et al., 2020) and applied by each facility. This 
includes use of medical disposable gowns, disposable latex gloves, face shield, surgical mask, 
and hand hygiene using alcohol 70% or alcohol gel. These supplies will be provided by each 
facility as requirements of usual treatment. 
Discussion 
Providing occupational therapy patient education that aim to improve the performance of 
patients with SCI in their ADL can optimize the outcomes of rehabilitation. The SADL-eM is 
an evidence-informed manual that supports a client-centred approach and aims to teach patient 
with SCI how to handle their ADL after injury and during inpatient rehabilitation phase. 
Quality and well-controlled clinical trials are essential to develop effective interventions for 
people with SCI. This randomized clinical trial aims to evaluate the impact of the SADL-eM 
intervention with SCI patients in inpatient rehabilitation setting in the Gaza strip, Palestine. If 

the SADL-eM is demonstrated to be clinically effective, it will have significant implications 
for occupational therapy research and practice. 
Trial status 
Recruitment is expected to start by March 2021 and is due to continue until the February 2022. 
The pilot study will start in January 2020. 
Abbreviations 
ADL: Activities of Daily Living, SCI: Spinal Cord Injury, SCIM-III: Spinal Cord 
Independence Measure-III, SCIM-SR: Spinal Cord Independence Measure-Self-Reported, 
SADL-eM: SCI ADL Educational Manual 
Competing interests 
The authors declare that they have no competing interests. 
Funding 
This study protocol received no specific grant support from any funding agency in the public, 
commercial, or not-for-profit sectors. 
Authors’ contributions 
MAM, MSB, and NAP developed the concept for the trial; drafted the protocol; contributed to 
the trial design and methodology; developed the SADL-eM intervention; adapted the trial 
protocol as a protocol paper; and reviewed and commented on drafts of the paper and approved 
the final version. MAM, MSB, NAP, and AB developed the statistical analysis plan. 
 
Acknowledgements 
The researches acknowledge all endeavors devoted to achieve this protocol. 

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Figure 1. Study Flow Diagram (CONSORT Statement) dummy 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Follow-Up 
Analysis 
Analysed (n= 45) 
 
Excluded from analysis (give reasons) (n= 0) 
Lost to follow-up (give reasons) (n= 1) 
Discontinued intervention (give reasons) (n= 1) 
Lost to follow-up (give reasons) (n= 2) 
Discontinued intervention (give reasons) (n= 2) 
Enrollment 
Analysed (n= 45)  
 
Excluded from analysis (give reasons) (n= 0) 
Allocated to control group (n1= 52) 
 
Received standard care (n= 49) 
 
Did not receive standard care (give reasons) 
(n= 3) 
Allocation 
Allocated to intervention group (n2= 50) 
 
Received allocated intervention (n= 47) 
 
Did not receive allocated intervention (give 
reasons) (n= 3) 
Randomized (N= 102) 
Excluded (n= 30) 
 
Not meeting inclusion criteria (n= 20) 
 
Declined to participate (n= 5) 
 
Other reasons (n= 5) 
Assessed for eligibility (n= 132) 

 
Figure 1: Random generated numbers of intervention group 

Box 1: inclusion and exclusion criteria 
Inclusion criteria 
 
Confirmed SCI diagnosis by computed tomography or magnetic resonance report. 
 
ASIA: A, B, and C 
 
Age between 18 and 65 years old. 
 
Stable medical condition. 
 
Time elapsed after SCI is not more than 6 months. 
 
Minimum time of stay in inpatient rehabilitation unit is six weeks. 
 
Active involvement in rehabilitation program. 
 
Sufficient comprehension (read/write) of the Arabic language. 
Exclusion criteria 
 
Unconfirmed diagnosis. 
 
Patients who have communication and/or cognitive disorders such as global aphasia and memory deficit. 
 
Patients with disturbed level of awareness such as coma or lethargy. 
 
Time elapsed since SCI is more than 6 months. 
 
ASIA: D and E 
 
Unstable medical condition. 
 
Patients who have other cause(s) of disability in addition to SCI such as stroke or amputation. 
 
Age less than 18 or more than 65 years old. 
 
Time of stay in inpatient rehabilitation unit is less than six weeks. 
 
Inactive involvement in rehabilitation program. 
 
Patients with a progressive disease or a psychiatric condition that would interfere with active participation 
in rehabilitation program. 
 
Patients with cardiovascular contraindications. 
 
Persons who become walking ambulatory during the inpatient period. 
 
Persons with complete tetraplegia C4 or above. 
 
Persons on mechanical ventilator.