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

Find out the effectiveness of the virtual reality rehabilitation-based approach compared to the task-specific training and conventional training on the balance function of CP children.

36 participants will be randomly allocated in one of 3 groups, this is a blinded, randomized controlled trial

Participants will be blinded. They will be assessed 3 times; T0: baseline assessment, T1: post-training assessment (after 6-week training) and T2: follow-up assessment (6 weeks after finishing the intervention).

Spastic CP with age between 4 to 12 years old; GMFCS-ER I and II no surgical intervention for spasticity, No injection of Botulinum for spasticity in the last 6 months.

Group 1: Virtual Reality Rehabilitation-Based Therapy 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. A trained physical therapist will supervise and assist the child’s practice by providing physical support if needed to maintain balance or by providing feedback to adjust the practice. He will consider the progression in the difficulty level of each game based on the balance performance improvement of each child over 6 weeks of training. Group 2: Balance-Specific Training The program includes 13 balance-specific exercises for 18 sessions over 6 weeks, 3 sessions per week. Group 3: control group Participants will continue their conventional rehabilitation protocol. 3 sessions per week for 6 weeks will be delivered.

Pediatric Balance Scale Gross Motor Function Measures - D & E 5 Times Sit-To-Stand Center of Pressure sway measures Center of Mass displacement measures

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).