Efficacy of Nintendo WII and Exercises at Rehabilitation of Individuals With Parkinson's Disease: Randomized Clinical Trial
Phase: NA
Conditions: Parkinson Disease
Sponsor: Federal University of Bahia

 
 
 
FEDERAL UNIVERSITY OF BAHIA 
 
 
 
 
 
 
 
 
 
PIETRO ARAÚJO DOS SANTOS 
 
 
 
 
 
 
 
 
 
 
 
NINTENDO WII AND EXERCISES AT REHABILITATION OF INDIVIDUALS 
 
WITH PARKINSON’S DISEASE 
 
 
 
 
 
 
 
STUDY PROTOCOL AND STATISTICAL ANALYSIS PLAN 
 
 
 
 
NCT03235284 
 
 
 
 
 
 
 
 
 
Salvador 
 
11/09/2019

Intervention 
 
 
 
Interventions were conducted in all groups for 50 minutes a day, twice a week for 8 weeks, 
accounting for  16 total sessions.  All activities were performed under  the direct supervision of 
trained  physiotherapists,  and  assessments  and  interventions  always  occurred  1  hour  after 
Levodopa (on-period) administration. 
Virtual rehabilitation with NW was performed in a room with an area of 20m2, equipped 
with the NW system (Nintendo Company,  Minami-ku-based,  Kyoto,  Japan) and a  multimedia 
device that projected the image on the wall at a height of one meter and twenty centimeters. In 
addition, the NW Wii Balance Board (WBB) platform(used for Wii Fit gaming) was used, in which 
it has four pressure sensors that detect the movements of the player standing on it in the orthostatic 
position,  instantly  demonstrating  the  position  of  the  feet,  the  weight  distribution  and  the 
displacement of the center of mass18. 
GNW performed 40 minutes  of training with NW, where patients played 4 games (Wii 
Sport and Wii Fit) standing up. In the first session, they played Boxing and Soccer Heading, and 
in the second session Golf and Running. Each game was held for 20 minutes with intervals of 1 
minute rest every 5 minutes of activity. The games were chosen to facilitate lateralization, rotation 
and extension of the trunk, mobility of the upper limbs, transfer of weight, equilibrium reactions 
and stationary gait. 
The ECs were performed through diagonal, active-assisted and resisted active movements, 
based on the proprioceptive neuromuscular facilitation (FNP) patterns in the upper limbs, scapula, 
pelvis and lower limbs. The protocol was also composed of gait training, in which the "gait cycle" 
was performed, where the physiotherapist offered a manual resistance to the hip during the step 
movement. 
The GEC performed 40 minutes of exercises with objectives similar to the GNW group. 
During  each  session,  30  minutes  of  specific  diagonals  were  performed,  being  upper  limbs 
(flexion- abduction-external rotation / extension-adduction-internal rotation); scapula (elevation 
and posterior depression), pelvis (anterior elevation / posterior depression), lower limbs (flexion- 
abduction-external rotation / internal extension-adduction-rotation), 10 minutes of orthostasis gait 
training or trunk extension training in Ductus dorsal, always respecting the interval of 1 minute of 
rest every 5 minutes of activity. In the first weekly session the exercises were performed for 
scapula, upper limbs and trunk, while in the second session exercises for pelvis, lower limbs and 
gait. 
 
In  GNWEC,  the  combination  of  therapies  was  administered  for  40  minutes,  with  20 
minutes of training with NW and 20 minutes of EC. Each intervention was applied in a similar 
way to the other  groups, and the games or exercises were distributed according to the weekly 
session. In addition, all groups performed muscle stretching of the upper and lower limbs for 10 
minutes

before initiating the interventions, and all patients were verbally oriented and stimulated by the 
therapist to perform the activities. 
 
 
2.2. Primary outcome 
 
The primary outcome was the functional balance, which was evaluated through the Berg Balance 
Scale (BBS). This ferment is composed of 14 items, graduated from 0 to 4 points that allow to 
measure  the  balance  through  progressively  more  challenging  tasks.  It  presents  a  total  score 
varying from 0 to 56 points, and a higher score reflects a better body balance. 
 
 
 
2.3. Secondary Results 
 
The gait was evaluated through the Dynamic Gait Index (DGI) scale, a tool composed of 8 tasks, 
a  score  ranging  from  0  to  3  points,  involving  gait  in  different  sensory  contexts,  reaching  
a maximum score of 24 points. 
The Timed "Up & Go" test (TUG) was also used to assess functional mobility, in which this test 
measures in seconds the time it takes for an individual to lift a standard armchair, walk a distance 
of 3 meters, walk back and sit again. The longer the time to perform the activity, the greater the 
physical mobility deficit. 
Quality  of  life  was  assessed  using  the  Parkinson's  Disease  Questionnaire  (PDQ-39),  which 
consists  of  39  items  divided  into 8  domains:  mobility,  daily  living activities,  emotional well- 
being, stigma, social support, cognition, communication and bodily discomfort . The total score 
varies from 0 to 100, in which a lower score denotes a better perception of the patient's quality of 
life. 
 
 
2.4 Statistical analysis Plan 
 
 
Data  were  analyzed  using  statistical  software  SPSS  21.0  27.  A  descriptive  analysis  (mean, 
standard deviation,  median and interquartile range for  quantitative variables,  and absolute and 
relative frequency for qualitative variables) was performed to identify the characteristics of the 
study sample. To test the existence of pre and post intervention differences, as well as between 
each group, in balance, mobility and quality of life, a mixed ANOVA of repeated measures was 
used. In addition, distribution symmetry and the Shapiro-Wilk test were performed to identify the 
normality of the data. The level of significance adopted for this study was 5%.