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

University of Vic - Central University of Catalonia

Status: Not yet enrolling

Conditions: Cerebral Palsy, Spastic

Treatments: Other: Treadmill training; Other: Treadmill training with virtual reality

Study type: Interventional

Funder types: Other

Identifiers

NCT05131724

VirtWalkCP

Details and patient eligibility

About

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.

Full 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).

Enrollment: 30 estimated patients

Sex: All

Ages: 4 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Medical diagnosis of spastic cerebral palsy
• Motor function levels I to III according to the Gross Motor Function Classification System
• Independent walking was acquired for more than 12 months.
• Able to ambulate for at least 10 meters with or without aids.

Exclusion criteria

• Orthopaedic surgery on the lower limbs in the past 12 months.
• Scheduled surgery during the period of the study.
• Orthopaedic deformities with surgery indication.
• Uncontrolled seizure disorder.
• Metallic implant in the skull.
• Hearing aid.
• Have received toxic botulin injections in the past 6 months.
• Significant cognitive or visual impairment.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Treadmill training

Active Comparator group

Description:

The treadmill training would be 10 sessions over 2 weeks with 30 minutes for each session (5-min warm-up; 20 min gait training; 5-min cool-down). During the sessions, treadmill speed will be maintained at 60 to 80% of the maximum speed established on an exertion test. The child will walk at 60% maximum speed in the first and final five minutes and 80% in the middle 20 minutes.

Treatment:

Other: Treadmill training

Virtual reality

Experimental group

Description:

Infants in the TTVR group will perform gait training on the treadmill simultaneously with virtual reality.

Treatment:

Other: Treadmill training with virtual reality