Faculty of Physical Therapy
Cairo, Cairo Governorate, 11432, Egypt
NCT Number: NCT07792278
Hemiplegic cerebral palsy (HCP) is a neurological disorder that affects one side of the body, resulting in muscle weakness and impaired balance. Virtual reality (VR) is a promising tool in pediatric rehabilitation due to its engaging and interactive nature. Aim: To investigate the effect of VR on lower-limb muscle strength and balance in children with HCP. Methods:30 children with HCP aged 7-10 years were randomly allocated to two equal groups. The control group received a selected physical therapy program, whereas the study group received the same program combined with fully immersive VR training. The total treatment period was 8 weeks. Lower-limb muscle strength was assessed using a Lafayette hand-held dynamometer. The Five Times Sit-to-Stand Test was used to assess functional lower-limb strength, and the Pediatric Balance Scale was used to assess balance.
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Notify Me7 year–10 year
All sexes
Interventional
Not applicable
Cairo, Cairo Governorate, 11432, Egypt
Cerebral palsy (CP) comprises a group of disorders resulting from injury to the developing brain, affecting motor function and postural control. Hemiplegic cerebral palsy (HCP) predominantly impacts one side of the body, accounting for approximately 38% of all cases of CP. Weakness is more prominent in distal muscle groups, with the hip extensors, knee extensors, and ankle dorsiflexors demonstrating more weakness than their antagonistic muscle groups. Virtual reality (VR) has been implemented in the treatment of children having CP. VR rehabilitation facilitates training across various complexity levels, while providing feedback within a safe and controlled setting. VR allows therapists to regulate the duration and intensity of tasks that are not feasible in the actual world. This study aimed to investigate the effect of fully immersive VR as an adjunct to the rehabilitation program of children with HCP for improving the clinical outcomes of lower-limb strength and balance. G*POWER statistical software (version 3.1.9.2) was utilized with α=0.05, 80% power, and an allocation ratio of N2/N1 = 1. For this study, a minimum sample of 30 children, 15 in each group, was considered adequate, based on Modified Ashworth Scale Grade 1, 1+, and Gross Motor Function Classification System. The control group received a selected physical therapy program 60 minutes and were conducted three times weekly for 8 consecutive weeks. The study group received a similar program of the control group along with VR-based training for 20-30 minutes each, three times weekly, across 8-week duration. Lafayette hand-held dynamometer, Five repetition sit to stand test, and Pediatric Balance Scale was utilized for evaluation.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A selected physical therapy program based on NDT principles according to for 60 minutes, 3 times/week for 6 successive weeks including the following exercises: strengthening exercises, stretching exercises, facilitation of postural reactions from standing position including: standing on one leg, weight shifting from standing position, stoop and recover from standing, squat from standing, standing on balance board and pushing the child in different directions and gait training activities for correction of gait pattern including: walking on balance beam, walking on balance board, walking on uneven surface, walking using different obstacles (rolls, wedges, stepper) and walking up and down stairs
Children in the study group only were given the same selected program as the control group, along with VR training using two interactive VRapeutic therapeutic games. Viblio, and Garden Do modules were chosen for their focus on functional, engaging virtual tasks that require movement and balance. VR sessions were conducted for 20-30 minutes each, three times weekly, across 8-week duration. The equipment included VRapeutic immersive rehabilitation system (VRapeutic Inc.); Lenovo IdeaPad 110 laptop (Intel Core i5-6200U CPU, 16 GB RAM, AMD Radeon R5 M430 GPU) running the VRapeutic software (developed with Unity™ 2019.4.40f1 LTS), Oculus Quest 2 VR headset (head-mounted display with 1440×1600 resolution per eye and a 96°×94° field of view), and two Oculus Touch handheld controllers, LED screen (43") was also used to guide the session
Time frame: 1. Pre-treatment at base-line of the study. 2. Post-treatment after 8 weeks of intervention.
[Model: 01163, Lafayette Instrument Company, USA] was used for objective measurement of isometric muscle strength of the hip, knee muscle groups. The HHD was calibrated by the manufacturer before assessment. Hip flexors and knee extensors were assessed in a sitting position; hip abductors were assessed in a supine posture; and hip extensors and knee flexors were assessed in a prone position. The child was assessed in three distinct positions: supine, prone, and sitting. The child was asked to perform two warm-up trials at sub maximal effort without the transducer being placed on the limb. Transducer was subsequently placed on the limb, and the child performed three maximal attempts lasting 5 seconds each, with a 30-second rest interval between trials. The child was instructed and verbally prompted to exert maximal force during the test, while the examiner resisted the child's maximal voluntary contraction, representing the maximal isometric force. Peak isometric presented in Newtons.
Time frame: 1. Pre-treatment at base-line of the study. 2. Post-treatment after 8 weeks of intervention.
FTSST is a reliable evaluative test used to assess lower-limb functional strength and has demonstrated correlations with functional balance ability assessments among children with CP. Test tools include a height-adjustable chair without an arm rest and a stopwatch. A stopwatch was used to measure how long it takes to perform five successive sit-to-stand-to-sit cycles as fast as possible.
Time frame: 1. Pre-treatment at base-line of the study. 2. Post-treatment after 8 weeks of intervention.
PBS was used to evaluate the participants' functional balance, which is a valid and reliable scale. The scale comprises the following equipment: height-adjustable bench, chair with lumbar support and armrests, stopwatch or watch with a second hand, one-inch-wide masking tape, step stool six inches in height, chalkboard eraser, ruler or yardstick, and small level. It consists of 14 items. Every item has a score between 0 and 4, where higher scores correspond to better balance.
Time frame: 1. Pre-treatment at base-line of the study.
Modified Ashworth' Scale for selecting children (MAS) was used to evaluate spasticity, which is manifested by an increased resistance of joints to passive movement. It is administered easily and in a short-time, and includes grades from (0 to 4) to determine spasticity . Children with grades of 1 or 1+ (mild spasticity) in the affected limb were considered eligible for inclusion
Time frame: 1. Pre-treatment at base-line of the study.
Gross Motor Function Classification System (GNFCS) is a practical system that can be used in the clinics and rehabilitation team. The GMFCS is a reliable, valid and standard method for classifying gross motor function into five levels with emphasis on transfer, sitting and mobility. A five-level scale from Level I (very independent) to Level V (very limited) to categorize the degree to which children with CP can perform gross motor skills. The child was observed performing age-appropriate functional activities without assistance, only children classified as Level I (independent ambulation) were included in the study.
Adly A Adam
Other
Full-Immersive Virtual Reality for Lower Limb Strength and Balance in Children With Hemiplegic Cerebral Palsy: A Randomized Controlled Trial
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