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IRCT20090301001722N25 IRCT 2020-07-30 Tehran University of Medical Sciences Effectiveness of virtual reality rehabilitation-based approach compared to balance-specific training and conventional training on balance function of cerebral palsy children: A randomized controlled trial Effectiveness of virtual reality rehabilitation-based approach compared to balance-specific training and conventional training on balance function of cerebral palsy children: A randomized controlled trial 2020-09-22 anticipated 36 Complete https://irct.ir/trial/46102 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization The block randomization method is designed to randomize subjects into groups that result in equal sample sizes. This method is used to ensure a balance in sample size across groups over time. Blocks are small and balanced with predetermined group assignments, which keeps the numbers of subjects in each group similar at all times.[1,2] The block size is determined by the researcher and should be a multiple of the number of groups (i.e., with two treatment groups, block size of either 4, 6, or 8). Blocks are best used in smaller increments as researchers can more easily control balance.[10] After block size has been determined, all possible balanced combinations of assignment within the block (i.e., equal number for all groups within the block) must be calculated. Blocks are then randomly chosen to determine the patients’ assignment into the groups. Although balance in sample size may be achieved with this method, groups may be generated that are rarely comparable in terms of certain covariates. For example, one group may have more participants with secondary diseases (e.g., diabetes, multiple sclerosis, cancer, hypertension, etc.) that could confound the data and may negatively influence the results of the clinical trial.[11] Pocock and Simon stressed the importance of controlling for these covariates because of serious consequences to the interpretation of the results. Such an imbalance could introduce bias in the statistical analysis and reduce the power of the study. Hence, sample size and covariates must be balanced in clinical research The size of each block in the present study (i.e. Sealed pocket) is 12 patients and in total 36 patients participate in 3 blocks. Thus, in intervention group 1 (block 1: virtual reality training, n = 12), in intervention group 2 (block 2: special balance training, n = 12) and in the control group (block 3: conventional rehabilitation, n = 12) will be allocated. Block Randomization will be used and stratified based on the time when the child joins the study with respect to GMFCS levels (I or II). N/A Cerebral Palsy. Intervention 1: First Intervention Group: Virtual Reality Training: During virtual reality rehabilitation-based therapy period children ,CP children, will play a video game of the X-box One-S using the Kinect device for motion capture. The selection of the Xbox One-S (Microsoft) was based on to combine it with the Kinect, a full-body 3D motion capture system, that enables the user to control the avatar and to interact with the virtual environment without the need for a game controller, through a natural user interface mainly using gestures and body movements. The intervention consists of a 6-week program, 3 individual sessions per week of 60 minutes each. In the session, the child has the opportunity to play 10 games per session in order to practice 5 minutes for each game. In addition, we will ask him/her to play games from the entire below-mentioned games category in order to simulate the real movement practices. A trained physical therapist will supervise and assist the child’s practice by providing physical support if needed (i.e. in case that the child needs some help) to maintain balance or by providing feedback to adjust the practice. Specific balance training games will be used as intervention protocol as mentioned in the table below. The physiotherapist will consider regarding the progression in the difficulty level of each game based on the balance performance improvement of each child over 6 weeks of training. A pre-training session will be delivered for each participant in this group in order to ensure that all children know how the Xbox Kinect works and the goal of the individual games. For children with high risk of fall, small parallel bars will be used. Based on previous studies about the effectiveness of different Xbox games, we had chosen games that recruiting body movement and balance adjustments of the activity of daily living taken into account the possibility of increasing the difficulty level according to the balance performance of children. For this reason, the following Kinect games will be used: 1) Kinect Sports, 2) Kinect Adventures, 3) Your Shape Fitness Evolved, and 4) Carnival. An 18-session sequence of gaming will be established to help the therapist assure a controlled progression. Intervention 2: Second Intervention group: Balance-Specific Training: In this group our patients are trained by using the balance-specific training program including the following exercises: Sitting to standing/ Standing to sitting/ Transfers/ Standing unsupported/ Sitting with back unsupported / Standing with feet together/ Standing unsupported with one foot / Standing on one leg/ Turning 360 degrees/ Turning to look behind / Retrieving object from floor/ Placing alternate foot on step stool / Reaching forward. Intervention 3: Control group: In this group, our participants,CP children, will continue their conventional rehabilitation protocol. 3 sessions per week for 6 weeks will be delivered with respect to some instructions such as the necessity of using functional exercises to manage the balance deficits, the use of stretching to maintain muscle elasticity and to prevent the dominance of spasticity and the use of exercises similar to that of the activity of daily living.An expert physiotherapist will provide the training (more than 5 years experience in the CP rehabilitation). Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Hussein Ziab
Tohwitat Ghadir, Jal Balah Street
Beirut Lebanon 00961 +961 70 804 130 houssein.ziab@gmail.com Tehran University of Medical Sciences scientific Dr. Mohammad-Reza Hadian Rasanani
Enghelab Avenue, Next to Safialishah
Tehran Iran (Islamic Republic of) 11489651111 +98 21 7753 3939 hadianrasan@gmail.com Tehran University of Medical Sciences Lebanon Cerebral palsy children diagnosed as spastic monoplegia, hemiplegic and diplegic patients; Children with age between 4 to 12 years old; Children able to walk (Grade I and II according to GMFCS-ER); The degree of spasticity in involved lower extremities according to the Modified Ashworth Scale should be ranged between grade 1 and grade 2. Children able to understand the instructions of the therapist and the games; Children did not receive any surgical intervention or any injection of Botulinum toxin in the last 6 months. No visual, cognitive or auditory impairments that would interfere with gameplay; Regular past use of an AVG system at home (more than 1 hour/week for more than 4 weeks in the past year). 4 years 12 years Both Children who refused to continue the study. G80 Cerebral palsy Rehabilitation Rehabilitation Rehabilitation First Intervention Group: Virtual Reality Training: During virtual reality rehabilitation-based therapy period children ,CP children, will play a video game of the X-box One-S using the Kinect device for motion capture. The selection of the Xbox One-S (Microsoft) was based on to combine it with the Kinect, a full-body 3D motion capture system, that enables the user to control the avatar and to interact with the virtual environment without the need for a game controller, through a natural user interface mainly using gestures and body movements. The intervention consists of a 6-week program, 3 individual sessions per week of 60 minutes each. In the session, the child has the opportunity to play 10 games per session in order to practice 5 minutes for each game. In addition, we will ask him/her to play games from the entire below-mentioned games category in order to simulate the real movement practices. A trained physical therapist will supervise and assist the child’s practice by providing physical support if needed (i.e. in case that the child needs some help) to maintain balance or by providing feedback to adjust the practice. Specific balance training games will be used as intervention protocol as mentioned in the table below. The physiotherapist will consider regarding the progression in the difficulty level of each game based on the balance performance improvement of each child over 6 weeks of training. A pre-training session will be delivered for each participant in this group in order to ensure that all children know how the Xbox Kinect works and the goal of the individual games. For children with high risk of fall, small parallel bars will be used. Based on previous studies about the effectiveness of different Xbox games, we had chosen games that recruiting body movement and balance adjustments of the activity of daily living taken into account the possibility of increasing the difficulty level according to the balance performance of children. For this reason, the following Kinect games will be used: 1) Kinect Sports, 2) Kinect Adventures, 3) Your Shape Fitness Evolved, and 4) Carnival. An 18-session sequence of gaming will be established to help the therapist assure a controlled progression. Second Intervention group: Balance-Specific Training: In this group our patients are trained by using the balance-specific training program including the following exercises: Sitting to standing/ Standing to sitting/ Transfers/ Standing unsupported/ Sitting with back unsupported / Standing with feet together/ Standing unsupported with one foot / Standing on one leg/ Turning 360 degrees/ Turning to look behind / Retrieving object from floor/ Placing alternate foot on step stool / Reaching forward Control group: In this group, our participants,CP children, will continue their conventional rehabilitation protocol. 3 sessions per week for 6 weeks will be delivered with respect to some instructions such as the necessity of using functional exercises to manage the balance deficits, the use of stretching to maintain muscle elasticity and to prevent the dominance of spasticity and the use of exercises similar to that of the activity of daily living.An expert physiotherapist will provide the training (more than 5 years experience in the CP rehabilitation). Gross Motor Function Measure (GMFM) - Dimensions D and E scores' change. Timepoint: Baseline, after 6 weeks training and 6 weeks follow-up. Method of measurement: Any change in the scores of Gross Motor Function Measure (GMFM) - Dimensions D and E. Pediatric balance scale scores. Timepoint: Baseline, after 6 weeks training and 6 weeks follow-up. Method of measurement: Any change in Pediatric balance scale. 5 times sit to stand test. Timepoint: Baseline, after 6 weeks training and 6 weeks follow-up. Method of measurement: StopwatchTime change's in 5 times sit to stand test by chronometer. Center of Pressure sway (velocity of displacement, and Standard deviation in medio-lateral and anteroposterior displacement). Timepoint: Baseline, after 6 weeks training and after 6 weeks follow-up. Method of measurement: Stabilometer. Digital Photography (Displacement of the center of mass, Body alignment, Segments alignment). Timepoint: Baseline, after 6 weeks training and after 6 weeks follow-up. Method of measurement: Nikon COOLPIX L340 camera. Tehran University of Medical Sciences Approved 2020-06-27 Ethics committee of Tehran University of Medical Sciences School of Rehabilitation of Tehran University of Medical Sciences, Piche Shemiran, Enghelab Ave, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)