(1)
Laboratory of Anatomy, Biomechanics and Organogenesis, Université Libre de Bruxelles, Brussels, Belgium
(2)
Department of Electronic and Informatics – ETRO, Vrije Universiteit Brussel, Brussels, Belgium imec, Leuven, Belgium
Ultimately, I feel that will be a key to the success of this watch, or any new wearable technology. With validation will come utilization and ultimately success. – Jon Meyer
6.1 Introduction
One of the conclusions of this review was that there was a lack of standardization for protocol (e.g., duration and number of sessions) and outcome measurements. Therefore, it is difficult to compare the studies published in this domain. However, there is sufficient evidence in support of SG to allow its inclusion in conventional treatment.
In this chapter, we are going to present a protocol designed for the validation of the integration of serious games in the treatment of children with cerebral palsy (CP) (e.g. Sharan et al. 2012). The protocol, (e.g. number of patients, tests used) can be adapted for other pathologies, the number of patients and the tests used must be adapted.
To increase levels of evidence, it is important to adopt standardized protocols (i.e., interventions, populations, and outcomes) and use common tools, allowing comparison between studies (Van Sint Jan et al. 2015). The aim of this large, multicenter study is to present a protocol to validate the use of SGs in conventional physical rehabilitation treatment for children with CP, using specially developed solutions.
6.2 Designs of RCTs to Validate the use of Serious Games
6.2.1 Design
The study will be a multicenter interventional randomized controlled trial (RCT). It will be a single-blind experiment: all testing will be performed by clinicians who are unaware of the group allocation. Because of the nature of the intervention, it is not possible to perform a double- or triple-blind study.
6.2.2 Setting
The flow chart for patient selection and repartition is presented in Fig. 6.1. The duration of the intervention will be 3 months. The patients will be randomly allocated to one of three groups:
One group receiving standard physiotherapy
One group receiving standard physiotherapy (50%) combined with SGs (50%)
One group receiving only SGs
Fig. 6.1
Flow chart for the study and patient selection
Five different evaluations will be performed during the study: one before the intervention (baseline); two during the intervention (one per month), to determine the best duration for the intervention; one immediately after the intervention; and one 3 months after the intervention, to determine whether progress is maintained over time (the timeline for the study is presented in Fig. 6.2).
Fig. 6.2
Timeline for the study, with the intervention steps and evaluations in the protocol
6.2.3 Participants
The inclusion criteria will include the age 6–18 years, a diagnosis of CP, the ability to stand (Gross Motor Function Classification System [GMFCS]: I-II-III), and the ability to understand the instructions (no cognitive [minimum IQ: >70] or language problems). The exclusion criteria will include use of trunk support, behavioral disorders, orthopedic interventions or botulinum toxin injections in the preceding 6 months, and the use of an intrathecal baclofen pump.
6.2.4 Materials
A platform for physical rehabilitation for children with CP, which includes specially developed serious games, has been designed and validated (Omelina et al. 2012). Several mini-games are available. Screenshots, descriptions of the games, and the therapeutic objectives of each game are presented in Tables 6.1 and 6.2. The system included a powerful configuration interface that allows the clinician to set all of the game (e.g., speed, visual complexity, and sounds) and play (e.g., joints and required range of motion) parameters. Therefore, each set of games can be adapted according to patient need and specificity (Omelina et al. 2012). Screenshots and explanations for this configuration interface are presented in Fig. 6.3. A Kinect™ sensor is used to control the games involving limb and trunk displacement, and a Wii Balance Board™ (WBB) is used for balance and posture training. This system has already been used in a feasibility study involving 10 children with CP (Bonnechère et al. 2017).
Table 6.1
Descriptions of the specially developed games used in the study
Games | Description | Therapeutic objectives |
|---|---|---|
Pirates | The patient must bring the pirate to the treasure by following the path. The width of the path can be configured. The formation of the path (e.g., lines, curves, and asymmetry) can be modified to increase difficulty | Fine adjustment of joint control to keep the pirate in line with the treasure. Limb coordination when the game is played using both limbs simultaneously. Visualization of the displacement of the pirates linked to limbs or trunk motion |
 | ||
Wipe out | The aim of the game is to clean the screen, which is covered in mud. The screen can be cleared with one or both hands (in this case, the screen is virtually divided to force the patient to move both limbs). The pictures behind the mud are changed each time, and the physiotherapist can ask questions about the pictures during the exercises | The precision and amplitude required to succeed can be altered according to the sensitivity of the game (see Fig. 6.3 for game configuration). The game requires coordination between the limbs. Visual feedback regarding the zone cleaned with one arm, relative to the other, provides interesting information for patients, particularly those with asymmetric symptoms. Patients are required to raise their arms to clean the upper corners. Repetitions of this type of exercise increase upper limb strength |
 | ||
Flight simulator | The patient is required to control the plane to collect stars and avoid asteroids. The direction of the plane is limited to medio-lateral displacement (1 direction) | – Control of trunk bending. The plane is controlled via bending; the trunk must remain in the frontal plane – The game can be controlled using the Wii Balance Board™. In this case, the plane is controlled via displacement of the center of pressure – Proprioception can be increased via live visual feedback regarding the plane’s movement via displacement of the center of pressure (Balance Board) or the trunk |
 | ||
Hit the box | The aim is to drop the boxes. The patient is required to keep the target in the correct position. After a predefined period (defined in the configuration), the ball is thrown. The direction of the plane is limited to medio-lateral displacement (1 direction) | – Fine adjustment of joint control to keep the target in the correct position – This game can be controlled via the Wii Balance Board™. In this case, the target is controlled via lateral displacement of the center of pressure – This game was developed to increase postural control. Indeed, posture needs to be maintained for a certain period (to be determined by the clinician) before the ball can be thrown – Visualization of displacement of the target linked to joint motion |
 | ||
Drop the ball | The patient is required to control the ball to ensure that it falls into the correct basket, by controlling the two boards. According to the therapeutic objectives of the game, the plates are controlled via the arms, trunk, or displacement of the center of pressure | – This game requires displacement of the center of pressure (in cases involving use of the Wii Balance Board™) or coordination between the arms (to control the upper plate) or the upper limbs and trunk (in cases involving use of the Kinect™ alone) to control the lower plate – The lower plate can be controlled via the Wii Balance Board™. In this case, the inclination of the plate is controlled via lateral displacement of the center of pressure – Visualization of displacement of the plates linked to arm motion and displacement of the center of pressure – Players are required to keep their arms flexed (approximately 90° of flexion) during the entire game. This task requires isometric contraction of the brachialis and deltoids (anterior head) |
 | ||
Mushrooms | The aim is to collect as many mushrooms as possible. The game was developed for hemiplegic patients with limbs in “triple flexion.” The game forces patients to stretch out the affected limb to collect the mushrooms. It also requires the control of trunk bending (to orient towards the other mushrooms in the environment). The game increases coordination between affected and unaffected limbs | – It is necessary for patients to control the position of the trunk (lateral bending) to collect the mushrooms. The trunk has to remain in a vertical position during the collection of the mushrooms and bend to rotate the environment – Two body segments are targeted. Proprioception of the trunk: the trunk must remain motionless, otherwise the environment will rotate. Proprioception of the limbs (particularly the affected one): he limb must be stretched outwards to collect mushrooms in a 3D environment |
 |
Table 6.2
Summary of the therapeutic objectives of each game
Fig. 6.3
(a) Configuration interface used to adapt the games to each patient. (b) A single touch is used to select a body segment. (c) An up-down gesture is used to specify the neutral position for the selected body segment. (d) A gesture involving two fingers is used to specify the range of motion for the selected joint
6.2.5 Interventions
The duration of the intervention will be 3 months, with three sessions per week, each lasting 30 min. The duration of the intervention and number of sessions are highly dependent on the study, and there is no consensus regarding the best treatment duration or number of sessions in the literature (Bonnechère et al. 2014). Therefore, we will perform intermediate evaluations during the intervention to analyze the patients’ progress (if any) over time and define the best duration for the intervention in future clinical use.
For the group receiving SG exercises, the order of the games and configuration used (game controllers and joints involved) will be defined at random to avoid effects of habituation or fatigue. Each game will be played for 5 min (3 different games in the group receiving combined physiotherapy and SGs, and 6 in the group receiving only SGs). At the end of the intervention, each game will be played for the same amount of time.
Relative to commercial video games, one of the advantages of specific games in rehabilitation is that they can be configured and adapted according to patient need and specificity. The games will be configured by a trained therapist during the first session of the intervention. This configuration will be modified according to the patients’ progress (or a familiarization with the games) after 1 and 2 months, to ensure that it is suits their abilities.
With respect to the standard physiotherapy, the therapist will not receive particular instructions, with the exception of those regarding the duration of the session, which is fixed to 30 min for the group receiving standard physiotherapy alone and 15 min for the group receiving standard physiotherapy combined with 15 min of SGs.
6.2.6 Outcomes
Several parameters will be evaluated during the study. A distinction will be made between the tests performed during evaluations (Fig. 6.2) and continuous follow-up performed during rehabilitation exercises.
6.2.7 Evaluation
All of the tests that will be performed during the five evaluations are presented in Table 6.3.
Table 6.3
Tests used to assess patients
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