Clinical trial NCT05131724: Effectiveness of Virtual Reality on Functional Mobility During Treadmill Training in Children With Cerebral Palsy
Official title: Effectiveness of Virtual Reality on Functional Mobility During Treadmill Training in Children With Cerebral Palsy: a Randomized Clinical Trial (VirtWalkCP Project)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cerebral Palsy, Spastic
Keywords: "Rehabilitation"[Mesh]
"Mobility Limitation"[Mesh]
"Virtual Reality"[Mesh]
Lead sponsor: University of Vic - Central University of Catalonia
Sponsor class: OTHER
First posted: 2021-11-23
Enrollment: 30
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Functional mobility change
timeFrame: Basal assessment, at the end of the intervention (an average of 3 weeks), 1 month after the end of the intervention (an average of 8 weeks).
Secondary outcomes:
measure: Static balance
timeFrame: Basal assessment, at the end of the intervention (an average of 3 weeks), 1 month after the end of the intervention (an average of 8 weeks)
measure: Dynamic balance
timeFrame: Basal assessment, at the end of the intervention (an average of 3 weeks), 1 month after the end of the intervention (an average of 8 weeks)
measure: Walking speed
timeFrame: Basal assessment, at the end of the intervention (an average of 3 weeks), 1 month after the end of the intervention (an average of 8 weeks)
measure: Gross motor function
timeFrame: Basal assessment, at the end of the intervention (an average of 3 weeks), 1 month after the end of the intervention (an average of 8 weeks)
measure: Functional independence
timeFrame: Basal assessment, at the end of the intervention (an average of 3 weeks), 1 month after the end of the intervention (an average of 8 weeks)
measure: Health-related quality of life
timeFrame: Basal assessment, at the end of the intervention (an average of 3 weeks), 1 month after the end of the intervention (an average of 8 weeks)
measure: Occupational participation
timeFrame: Basal assessment, at the end of the intervention (an average of 3 weeks), 1 month after the end of the intervention (an average of 8 weeks)
Other outcomes:
Locations:
city: Vic
country: Spain
facility: Univeristy of Vic - Central University of Catalonia
state: Barcelona
Study officials:
affiliation: University of Vic - Central University of Catalonia
name: Mirari Ochandorena-Acha, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Palisano R, Rosenbaum P, Walter S, Russell D, Wood E, Galuppi B. Development and reliability of a system to classify gross motor function in children with cerebral palsy. Dev Med Child Neurol. 1997 Apr;39(4):214-23. doi: 10.1111/j.1469-8749.1997.tb07414.x.
citation: Novak I, Morgan C, Fahey M, Finch-Edmondson M, Galea C, Hines A, Langdon K, Namara MM, Paton MC, Popat H, Shore B, Khamis A, Stanton E, Finemore OP, Tricks A, Te Velde A, Dark L, Morton N, Badawi N. State of the Evidence Traffic Lights 2019: Systematic Review of Interventions for Preventing and Treating Children with Cerebral Palsy. Curr Neurol Neurosci Rep. 2020 Feb 21;20(2):3. doi: 10.1007/s11910-020-1022-z.
citation: Chiu HC, Ada L, Bania TA. Mechanically assisted walking training for walking, participation, and quality of life in children with cerebral palsy. Cochrane Database Syst Rev. 2020 Nov 18;11(11):CD013114. doi: 10.1002/14651858.CD013114.pub2.
citation: Grecco LAC, Hugo P, Sampaio LMM, Oliveira CS. Evidence of the effect of treadmill training on children with cerebral palsy: A systematic review. Clin Exp Med Lett [Internet]. 2012;53(2):95-100. Available from: http://www.ceml-online.com/fulltxt.php?ICID=883582
citation: Grecco LA, Tomita SM, Christovao TC, Pasini H, Sampaio LM, Oliveira CS. Effect of treadmill gait training on static and functional balance in children with cerebral palsy: a randomized controlled trial. Braz J Phys Ther. 2013 Jan-Feb;17(1):17-23. doi: 10.1590/s1413-35552012005000066.
citation: Ochandorena-Acha M, Terradas-Monllor M, Nunes Cabrera TF, Torrabias Rodas M, Grau S. Effectiveness of virtual reality on functional mobility during treadmill training in children with cerebral palsy: a single-blind, two-arm parallel group randomised clinical trial (VirtWalkCP Project). BMJ Open. 2022 Nov 3;12(11):e061988. doi: 10.1136/bmjopen-2022-061988.