NCT05131724

Effectiveness of Virtual Reality on Functional Mobility During Treadmill Training in Children With Cerebral Palsy

Effectiveness of Virtual Reality on Functional Mobility During Treadmill Training in Children With Cerebral Palsy: a Randomized Clinical Trial (VirtWalkCP Project)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University of Vic - Central University of Catalonia · Academic / Other
• Sex: All
• Age: 4 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

Cerebral palsy (CP), which occurs as a consequence of brain damage, has multiple deficits such as a global reduction of motor cortical activity during movement execution and inadequate processing of corticospinal and somatosensory circuits. Global registers estimate that it occurs in two to three of 1.000 live births, and spasticity is the most common disorder, occurring in 80% of children with CP. Spasticity might affect both upper and lower limbs, resulting in other deficits in joint mobility, postural reactions, selective motor control, balance, and gait. This set of impairments and deficits may lead to limitations in functional ability and autonomy in the performance of daily living activities, physical fitness, quality of life, and/or ability to participate in games and sports activities compared to neurotypical peers of the same age. Walking is considered one of the most important activities in daily life, as it is essential for activities of daily living and social participation. Children with Gross Motor Function Classification System (GMFCS) levels I, II, and III show potential for walking, and around 75% of CP children are ambulatory. However, abnormalities in neural control and muscle weakness contribute to several gait characteristics such as slow velocity, decreased stride length, increased stance phase percentage, and increased peak ankle dorsiflexion and knee flexion, and peak hip extension moments. Consequently, this gait pattern contributes to postural instability and increased fall risk in children with CP, among others.

Detailed description

The main objective of the present study is to evaluate the effectiveness of treadmill gait training and virtual reality comparing to treadmill gait training on functional mobility in infants with spastic cerebral palsy. The study design is a two-arm randomized clinical trial, single-center and single-blind (evaluators). The sample will be recruited at the Hospital General de Vic, and the study will be conducted at the Universitat de Vic - Universitat Central de Catalunya (UVic-UCC).

Conditions

• Cerebral Palsy, Spastic

Interventions

Type	Name	Description
OTHER	Treadmill training with virtual reality	The virtual environment will be composed of obstacles, different paths, and narrow and deviated corridors. Walking through this environment will require the infant to coordinate walking behaviour and adjust the length, height, and width of steps to negotiate the obstacles on the television screen placed at the infant's eye level in front of the treadmill. The speed, orientation, size, frequency of appearance, and shape of the obstacles will be manipulated according to individual performance following a standardized protocol. The virtual system will provide visual and auditory feedback on the success or failure of the activity to enhance motor learning. In addition, the characteristics of the environment (e.g., visibility, configuration, and distractions) will be adjusted to increase the complexity of the training.
OTHER	Treadmill training	The RAM870A of the Medisoft treadmill will be used. Two treadmill training sessions will be held before the onset of the intervention to familiarize the children with the equipment. During these two sessions, the treadmill training and speed will be set according to the following procedures: the ground walking speed of each child will be determined through the baseline 6MWT, then the training velocity will be set at 50% of the maximum ground speed established during the 6MWT and increased gradually based on the tolerance of each child (i.e., no complaint of fatigue, heart rate not exceeding 70% of the maximum heart rate, and a lack of gait shuffling, buckling or dragging steps more than 5 seconds during walking).

Timeline

• Start date: 2022-09-01
• Primary completion: 2024-09-01
• Completion: 2025-09-01
• First posted: 2021-11-23
• Last updated: 2021-11-30

Locations

1 site across 1 country: Spain