The Comparison of Virtual and Real Boxing Training in Hemiparetic Stroke Patients: a Randomized Controlled Study
Phase: NA
Conditions: Stroke, Hemiparesis
Sponsor: Eastern Mediterranean University

NCT03651479 
 
 
 
STATISTICAL ANALYSIS PLAN 
FOR CLINICAL TRIAL 
 
 
Principal Investigator: Gözde İyigün 
 
 
 
  Assistant Professor, PhD, PT 
                                         Eastern Mediterranean University 
  
 
 
  Health Sciences Faculty  
   
 
 
  Physiotherapy and Rehabilitation Department 
  Famagusta, North Cyprus via Mersin 10, TURKEY 
 
Official Study Title: The Comparison of Virtual and Real Boxing Training in Hemiparetic 
Stroke Patients: a Randomized Controlled Study  
 
Clinical trial number: NCT03651479 
 
Protocol ID: 2018/02(a)-08 
 
Date: 09/08/2019 
 
 
 
 
 
 
 
 
 
 

NCT03651479 
 
Table of contents 
 
1. Introduction 
2. Study design  
3. Sample size calculation 
4. Aims and objectives 
5. Outcomes  
a. Primary outcome 
b. Secondary outcomes  
6. Statistical Methodology  
7. References  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

NCT03651479 
Contents  
1. Introduction: The most common presentation of a stroke patient requiring rehabilitation is 
contralateral hemiparesis or hemiplegia. Upper extremity hemiparesis is one of the most 
common conditions requiring rehabilitation and upper extremity dysfunction occurs in rates 
ranging from 30% to 66%.1 Upper extremity functional recovery is often slower than the 
recovery of lower extremity functions. 1,2 Only a small portion of stroke patients with upper 
limb motor impairment (12%) is able to regain full function, while the majority of the 
patients require constant care from family or social services.3 The aim of this study is to 
compare the effects of virtual and real boxing training on upper extremity functions 
(primary outcome measure), cognitive functions, balance functions and activities of daily 
living (secondary outcome measures) in hemiparetic individuals with stroke. This statistical 
analysis plan (SAP) will give more detailed descriptions of the endpoints in the study and 
the corresponding analyses. 
 
2. Study design: In this study participants who had a documented diagnosis of stroke from 
their neurologist from the local community will be screened for eligibility. The participants 
who are being diagnosed as first time ever stroke, who has hemiparesis, who are between 
the ages of 18-70, who has Mini Mental Test score ≥23, whose functional level is less than 
4 according to the Modified Rankin Scale and who has upper extremity spasticity <3 on 
Modified Ashworth Scale will be included in this study. Individuals will be excluded from 
the study if they have any of the following criteria: hypertension, heart disease, subluxation 
and fracture at the shoulder, visual impairment, limitation in passive normal joint movement 
in hemiplegic side and botulinum toxin administration or surgical operation in the last 6 
months. If the participants are eligible to participate they will be randomized to either the 
virtual boxing group (VBG) or the real boxing group (RBG). Each participant will be 
randomly assigned to either treatment group with simple randomization (odd - even 
numbers: odd numbers will represent VBG and even number will represent RBG). The 
study protocol is presented in Study protocol - CONSORT diagram below.  
 
3. Sample size calculation: Sample size will be calculated by using G* Power 3.1.9.2 
program. The mean and standard deviation values are taken as a reference from the study 
of Jo et al.4 Statistical power analysis calculations suggested 15 subjects for each group (α 
= 0.05, 95% confidence interval), considering the dropouts the number was increased by 
33% and finally 20 subjects planned to be included for each group. Based on the power 
calculation (n=20+20) we will enroll 40 individuals in each treatment group; n=20 in virtual 
boxing group (VBG) and n=20 in real boxing group (RBG).  
 
 
 
 
 

NCT03651479 
 
Study protocol (CONSORT diagram) 
 
 
 
4. Aims and objectives: To compare the effects of virtual and real boxing training on upper 
extremity functions (primary outcome measure), cognitive functions, balance functions and 
activities of daily living (secondary outcome measures) in hemiparetic individuals with 
stroke. 
 
5. Outcomes: This section will present the outcomes investigated to answer the study aims 
and objectives.  
 
5.1.Primary outcome: The primary outcome is Wolf Motor Function Test (WMFT) which 
quantifies upper extremity motor ability through the use of timed and functional tasks. 
The original version of the WMFT was developed by Wolf et al in 1989 to examine the 
patients with moderate to severe upper extremity motor deficits. 5 Than, the modified 
version of the test was developed by Taub et al to assess the motor abilities of chronic 
patients who had suffered mild to moderate stroke. 6 The widely used version of the 
WMFT consists of 17 items, items 7 and 14 are related to subject strength and the other 
15 to subject functional ability during various tasks. Performances are scored using a 6-
point functional ability scale and the less affected upper extremity followed by the most 
affected side. The total score, also referred to as Functional Ability score (WMFT-FAS), 
is the sum of the 15 items score (with a 6-point ordinal score from 0 to 5). The maximum 

NCT03651479 
total score is 75, with lower scores indicating lower functional levels.7 It will be 
measured at baseline (0 weeks) and at the completion of the treatment (8 weeks).  The 
change in scores from Baseline to 8 weeks will be calculated.  
 
5.2.Secondary outcomes: Minnesota Manual Dexterity Test (MMDT), Video Boxing 
Analysis (VBA), Fullerton Advanced Balance (FAB), Addenbrook Cognitive 
Assessment (ACE-R) and Frenchay Activity Index (FAI). The secondary outcome will 
be measured at the baseline (0 weeks) and at the completion of the treatment (8 weeks). 
The change in scores from Baseline to 8 weeks will be calculated. The estimated 
difference in mean change from baseline to 8 weeks and the corresponding 95 % 
confidence interval (CI) will be presented. 
 
5.2.1. Minnesota Manual Dexterity Test (MMDT): MMDT measures the speed of 
gross arm and hand movements (arm-hand dexterity) during rapid eye-hand 
coordination tasks. The MMDT material consists of a plastic collapsible board 
with 60 holes and 60 cylindrical blocks (3.7 cm in diameter and 1.9 cm high). 
The MMDT involve five subtests: Placing Test, Turning Test, Displacing Test, 
One-hand Turning and Placing Test, and the Two-hand Turning and Placing 
Test. The Placing Test (1st item: taking the blocks with one hand and putting 
them in the holes on the board in a standardized order) and Two-hand Turning 
and Placing Test (5th item: taking the blocks with two hands and putting them in 
the holes on the board in a standardized order) were the two items selected for 
this study. Participants were given a 15 second trial for both items. The test was 
timed with a stopwatch and each item was measured three times. The number of 
seconds it took to complete the task on each of the trials was recorded. An 
average score from the three trials was calculated. The high performer should 
score higher on the MMDT than the low performers.8,9 
 
5.2.2. Video Boxing Analysis (VBA): For boxing analysis patients were videotaped 
while punching with their right side, punching with side left and punching 
bilaterally. Than the videotape were watched to analyze and the number of right 
unilateral punches in 1 minute, number of left unilateral punches in 1 minute and 
number of bilateral punches in 1 minute were recorded. This analysis were done 
for the quantitative assessment of punch number per minute (number of 
punch/minute). This measurement method is created and constructed by the 
authors of this study. The lower the score, the better the outcome. 
 
5.2.3. Fullerton Advanced Balance (FAB): The FAB scale is a performance-based 
scale which was developed to evaluate changes in many aspects of balance.10 
The FAB scale consists of 10 test items for the evaluation of static and dynamic 
balance status. These test items are: 1. Feet together, eyes closed, 2. Reach 
forward to retrieve an object, 3. Turn in a full circle, 4. Step up and over a bench, 
5. Tandem walk, 6. Stand on one leg, 7. Stand on foam, eyes closed, 8. Two-
footed jump, 9. Walk with head turns, 10. Reactive postural control. Each test 

NCT03651479 
item is scored using a 0-4 scale. The highest score indicating better balance 
abilities is “40” points, and the lowest is “0”. The FAB-T (Fullerton Advanced 
Balance – Turkish) scale was found to be a reliable and valid measurement of 
balance in Turkish population. 11 
 
5.2.4. Addenbrook’s Cognitive Assessment – Revised (ACE-R) is sensitive in the 
differential diagnosis of early stage dementia.12 However, the design and 
psychometric properties is also suitable to provide information about cognitive 
functions and cognitive deficits in patients without dementia after a stroke.13 The 
ACE-R consists of five domains including attention/orientation, memory, verbal 
fluency, language and visuospatial ability.14 The total score in ACE-R is ‘100’ 
points, higher scores indicates better cognitive functioning. ACE- R scale was 
found as reliable and valid in Turkish population. 15 
5.2.5. Frenchay Activities Index (FAI) is a measure of instrumental activities of daily 
living (IADL) for use with patients recovering from stroke.16 The FAI assesses 
a broad range of activities associated with everyday life. The benefit of the FAI 
is that while activities of daily living scales tend to focus on issues related to 
self-care and mobility and it is an appropriate measure for functional outcome 
in stroke patients.17 The FAI comprises 15 activities, each of which is scored on 
a 4-point scale (0 to 3), to yield a total score ranging from 0 (inactive) to 45 
(active). Scoring is based on the frequency with which the activities are carried 
out. It can be broken down into three subscales: domestic chores, leisure/work, 
and outdoor activities. Each subscale's score ranges from 0 to 15.18 
 
6.  Statistical Methodology  
 
The statistical analysis will be carried out using the statistical package SPSS version 24.0. The 
variables will be reported by percentage (%) and mean ± standard deviation (x ± sd). Shapiro-
Wilk test will be used to determine whether the data had a normal distribution. Pearson’s Chi-
Squared Test and Fisher's Exact Test will be used for comparison of the categorical data 
between the groups. Mann-Whitney U test will be used to analyze the intergroup differences, 
and Wilcoxon Signed-Rank Test will be used to analyze the intragroup differences. P<0.05 will 
be accepted as the statistically significant level. The arithmetic means will be presented with a 
95% confidence interval (95% CI) with lower and upper limit values. Both “p” values and 95% 
CI values will be considered while interpreting the differences between the groups. To analyze 
the intergroup changes, effect sizes will be calculated with “Cohen’s d”. The effect sizes will 
be interpreted as small effect (d ≥ 0.2), medium effect (d ≥ 0.5) and large effect (d ≥ 0.8).[30] 

NCT03651479 
The mean difference (MD) will also calculated to evaluate the change from the baseline to post-
treatment as mean change ± standard deviation. 
 
7. References 
1.  
van der Lee JH, Wagenaar RC, Lankhorst GJ, Vogelaar TW, Devillé WL, Bouter LM. 
Forced Use of the Upper Extremity in Chronic Stroke Patients. Stroke. 1999. 
doi:10.1161/01.str.30.11.2369 
2.  
Kwakkel G, Wagenaar RC, Kollen BJ, Lankhorst GJ. Predicting disability in stroke - A 
critical review of the literature. Age Ageing. 1996. doi:10.1093/ageing/25.6.479 
3.  
Nichols-Larsen DS, Clark PC, Zeringue A, Greenspan A, Blanton S. Factors 
influencing stroke survivors’ quality of life during subacute recovery. Stroke. 2005. 
doi:10.1161/01.STR.0000170706.13595.4f 
4.  
Jo K, Jung J, Yu J. Effects of virtual reality-based rehabilitation on upper extremity 
function and visual perception in stroke patients: a randomized control trial. J Phys 
Ther Sci. 2012. doi:10.1589/jpts.24.1205 
5.  
Wolf SL, Catlin PA, Ellis M, Link Archer A, Morgan B, Piacentino A. Assessing Wolf 
Motor Function Test as Outcome Measure for Research in Patients After Stroke.; 2001. 
http://ahajournals.org. 
6.  
Taub E, Miller NE, Novack TA, et al. Technique to improve chronic motor deficit after 
stroke. Arch Phys Med Rehabil. 1993. 
7.  
Morris DM, Uswatte G, Crago JE, Cook EW, Taub E. The reliability of the wolf motor 
function test for assessing upper extremity function after stroke. Arch Phys Med 
Rehabil. 2001. doi:10.1053/apmr.2001.23183 
8.  
Desrosiers J, Rochette A, Hébert R, Bravo G. The Minnesota Manual Dexterity Test: 
Reliability, validity and reference values studies with healthy elderly people. Can J 
Occup Ther. 1997. doi:10.1177/000841749706400504 
9.  
Surrey LR, Nelson K, Delelio C, et al. A comparison of performance outcomes 
between the Minnesota Rate of Manipulation Test and the Minnesota Manual Dexterity 
Test. Work. 2003;20(2):97-102. 
10.  
Rose DJ, Lucchese N, Wiersma LD. Development of a Multidimensional Balance 
Scale for Use With Functionally Independent Older Adults. Arch Phys Med Rehabil. 
2006;87(11):1478-1485. doi:10.1016/j.apmr.2006.07.263 
11.  
Iyigun G, Kirmizigil B, Angin E, et al. The reliability and validity of the Turkish 
version of Fullerton Advanced Balance (FAB-T) scale. Arch Gerontol Geriatr. 
2018;78. doi:10.1016/j.archger.2018.05.022 
12.  
Mioshi E, Dawson K, Mitchell J, Arnold R, Hodges JR. The Addenbrooke’s Cognitive 
Examination revised (ACE-R): A brief cognitive test battery for dementia screening. 
Int J Geriatr Psychiatry. 2006;21(11):1078-1085. doi:10.1002/gps.1610 
13.  
Fiedorova D, Krulova P, Ressner P, et al. Addenbrooke’s Cognitive Examination in 
Nondemented Patients after Stroke. Neuropsychiatry (London). 2018;8(2):505-512. 

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doi:10.4172/Neuropsychiatry.1000372 
14.  
Morris K, Hacker V, Lincoln NB. The validity of the Addenbrooke’s Cognitive 
Examination-Revised (ACE-R) in acute stroke. Disabil Rehabil. 2012;34(3):189-195. 
doi:10.3109/09638288.2011.591884 
15.  
Gürvit IH, Baran B. Demanslar ve kognitif bozukluklarda ölçekler. Nöropsikiyatri 
Arşivi/Archives of Neuropsychiatry. 2007. 
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Holbrook M, Skilbeck CE. An activities index for use with stroke patients. Age Ageing. 
1983. doi:10.1093/ageing/12.2.166 
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Greveson GC, Gray CS, French JM, James OFW. Long-term outcome for patients and 
carers following hospital admission for stroke. Age Ageing. 1991. 
doi:10.1093/ageing/20.5.337 
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Segal ME, Schall RR. Determining functional/health status and its relation to disability 
in stroke survivors. Stroke. 1994. doi:10.1161/01.STR.25.12.2391