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Active Not RecruitingNCT07401108

Reactive Balance Training vs Virtual Reality in Hemiplegic Cerebral Palsy

Reactive Balance Training Versus Virtual Reality on Balance and Functional Abilities in Children With Hemiplegia

Status
Active Not Recruiting
Phase
N/A
Study type
Interventional
Enrollment
60 (actual)
Sponsor
Cairo University · Academic / Other
Sex
All
Age
6 Years – 10 Years
Healthy volunteers
Not accepted

Summary

This randomized controlled study compared the effects of Wii Balance Board training versus reactive balance training on balance control and functional abilities in children with spastic hemiplegic cerebral palsy. Sixty children aged 6-10 years (GMFCS levels I-II, mild spasticity) were randomly assigned to either a Wii-based balance training group or a reactive balance training group. Both groups received a conventional physical therapy program three times per week for eight weeks, with an additional 30 minutes of the assigned balance intervention per session. Balance and functional abilities were assessed before and after treatment using the HUMAC Balance System, Pediatric Balance Scale, Functional Reach Test, and Timed Up and Down Stairs test. The study aimed to evaluate and compare the effectiveness of both interventions in improving balance control and functional performance in this population.

Detailed description

This study was conducted as a randomized controlled trial to investigate and compare the effects of Wii Balance Board-based virtual reality training and reactive balance training on balance control and functional abilities in children with spastic hemiplegic cerebral palsy. Study Design and Participants Sixty children with spastic hemiplegia of both genders were recruited from Wahet Nour Elhayah Centers. Participants were aged between 6 and 10 years, classified as GMFCS levels I and II, and demonstrated mild spasticity (grades 1-1+ on the Modified Ashworth Scale). All children were able to follow verbal instructions and participate actively in assessment and treatment procedures. Children with musculoskeletal deformities, recent orthopedic surgery or botulinum toxin injections, uncontrolled seizures, cardiovascular or respiratory disorders, or visual or hearing impairments were excluded. Participants were randomly allocated into two equal groups (Group A and Group B) using a simple randomization method. Intervention Program Both groups received a conventional physical therapy program for 90 minutes per session, three times per week for eight weeks. This program included neurodevelopmental treatment techniques, stretching exercises for affected upper and lower limbs, upper limb strengthening and functional exercises, and gait training. In addition to conventional therapy, each group received a specific balance training intervention for 30 minutes per session. Group A: Wii Balance Board Training (Virtual Reality-Based Balance Training) Children in Group A participated in a structured balance training program using the Nintendo Wii Balance Board. Training was conducted three times per week for eight weeks. The program was designed to improve static and dynamic balance, weight-shifting ability, and sensorimotor integration through interactive virtual reality games. During the first two weeks, training focused on familiarization with the device and games, with close therapist supervision, manual assistance, and verbal cues to ensure proper movement execution and safety. As participants progressed, manual assistance was gradually withdrawn, and training during the remaining weeks relied primarily on verbal instructions. Each session was divided into three series. The first and second series included games such as Snowboard, Penguin Slide, and Super Hula Hoop, which required continuous weight shifting in the anteroposterior, mediolateral, and combined directions. Short rest periods (1-2 minutes) were provided between series to prevent fatigue. The third series involved relaxation and postural control exercises using the Yoga game, initially performed with eyes open and later with eyes closed to challenge sensory integration. This training approach emphasized continuous visual feedback, motivation, and active participation, aiming to enhance postural control through multisensory stimulation and task-oriented practice. Group B: Reactive Balance Training Children in Group B received a structured reactive balance training program, also delivered three times per week for eight weeks, with each session lasting approximately 30 minutes. The goal of this intervention was to improve the child's ability to recover balance in response to unexpected perturbations. Training included external perturbations, internal perturbations, and combinations of both. External perturbations were applied by the therapist through techniques such as lean-and-release maneuvers and sudden, unpredictable pushes to the shoulder or pelvis while the child stood on a stable or unstable surface. Children were instructed to maintain balance with minimal displacement of the center of gravity. Internal perturbations involved voluntary destabilizing tasks such as kicking or throwing a ball while maintaining postural stability. As participants' reactive balance responses improved, task difficulty was progressively increased by modifying perturbation magnitude, direction, and unpredictability, as well as by introducing sensory challenges or unstable support surfaces. This progression aimed to simulate real-life balance disturbances and enhance rapid postural responses. Outcome Measures and Assessment Procedures All participants were evaluated before and after the 8-week intervention period. Balance was objectively assessed using the HUMAC Balance System, including measures of center of pressure, limits of stability, and weight-shifting ability. Functional balance was assessed using the Pediatric Balance Scale. Functional performance was evaluated using the Functional Reach Test and the Timed Up and Down Stairs (TUDS) test. Purpose of the Protocol This protocol was designed to determine the effectiveness of Wii-based virtual reality training and reactive balance training in improving balance control and functional abilities in children with spastic hemiplegia, and to compare which approach yields superior clinical outcomes. The results are intended to guide evidence-based balance rehabilitation strategies for this population.

Conditions

Interventions

TypeNameDescription
DEVICEVirtual realityParticipants will undergo a structured balance training program utilizing the Wii Balance Board. The program will consist of three training sessions per week over an eight-week period. The first two weeks will focus on guided exercises with manual assistance and verbal instructions, ensuring that the children are comfortable and correctly performing the exercises. As the participants progress, the manual guidance will be gradually reduced, and verbal instructions alone will be provided for the remaining four weeks of training.
OTHERReactive Balance TrainingIn reactive balance training, each session will include 3-4 of the following five core exercises: lean and release, push/pull, reaching with unexpected perturbation, weight shifting on unstable surfaces, and trip/slip simulation. Exercises will be divided into 2-3 blocks, with 6-8 perturbations in each block and short rest periods between blocks (1-2 min), for a total of 30-40 perturbations per session.

Timeline

Start date
2025-05-24
Primary completion
2026-02-23
Completion
2026-05-15
First posted
2026-02-10
Last updated
2026-02-10

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT07401108. Inclusion in this directory is not an endorsement.

Reactive Balance Training vs Virtual Reality in Hemiplegic Cerebral Palsy (NCT07401108) · Clinical Trials Directory