Clinical trial NCT05670522: Transcranial Direct Current Stimulation Versus Virtual Reality on Gait in Children With Spastic Diplegia
Official title: Transcranial Direct Current Stimulation Versus Virtual Reality on Gait in Children With Spastic Diplegia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: Transcranial direct current stimulation
virtual reality
gait intervention
cerebral palsy
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
Collaborators: name: Shirley Ryan AbilityLab
name: Cairo University
First posted: 2023-01-04
Enrollment: 40
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Spastic diplegia is the most frequent type of cerebral palsy (CP), and impaired gait is a common sequela of this condition. The investigators compared the effects of two novel research interventions transcranial direct current stimulation (tDCS) and virtual reality (VR) on gait impairments in children with spastic diplegia.

Currently, both tDCS and VR require further investigation to determine their clinical effectiveness for children with CP. Thus, the aim of this study was to compare the effects of tDCS and VR training on spatiotemporal and kinetic gait parameters in children with spastic diplegia, as a supplemental intervention to traditional physical therapy.

Detailed description: Cerebral palsy (CP) is caused by early-stage brain injury, affecting 2 to 3 children in every 1000 live births. CP is divided into different subtypes depending on the dominant neurological signs: spastic, dyskinetic, or ataxic. Epilepsy and intellectual disability, as well as problems with speech, hearing, and vision, are all common complications \[1\]. spastic diplegic CP is one of the most common developmental disabilities throughout life, caused by large-scale changes in subcortical brain activity with a reduced activation of corticospinal and somatosensory circuits, which leads to diminished activation of the central nervous system during volitional activities.

Gait impairment is seen in 90% of children with spastic diplegic CP, stemming from this decreased cortical excitability and compounded by spasticity of the lower extremities, excessive muscular weakness, impaired joint mobility, and poor coordination and balance. Specifically, children with CP have reduced gait velocity, cadence, and stride length, among other affected spatiotemporal gait parameters. The International Classification of Functioning Disability and Health consider changes in the spatial and temporal characteristics of gait to be important predictors to poor function and community participation. Additionally, crouched gait, scissoring, and other atypical gait patterns are common in this population, further affecting the kinematic and kinetic characteristics of gait and leading to metabolically expensive locomotion, high fall risk, and long-term musculoskeletal injury. For children with spastic diplegic CP, the primary goal of rehabilitation is to facilitate mobility and appropriate walking patterns with or without external assistance. Improving spatiotemporal and kinetic characteristics of gait would improve gait function, increase gait efficiency, and reduce the risk of long-term disability. In turn, it would allow these children to participate in more activities of daily living, meaningful interactions with family and society, and environmental exploration, as well as to improve their physical development.

In the current study, the investigators considered two technology-driven strategies that could potentially target gait impairments and improve gait function in children with CP: virtual reality (VR) and transcranial direct current stimulation (tDCS). Both interventions have been studied for their therapeutic potential with mixed results, especially in children. Specifically, VR can simulate real-life activities while providing repetition, augmented sensory input and feedback, error reduction/augmentation to increase motivation during the rehabilitation process. As a training tool, VR provides visual perceptual stimulation resulting from dynamic changes in context, which may aid in the execution of regulated exercises while also requiring concentration and additional postural control. Neuroimaging studies suggest that VR can facilitate learning and recovery by stimulating cortical reorganization and neural plasticity. Previous research has utilized VR as a therapeutic tool for children to improve balance, walking speed, and/or distance, as well as to encourage physical activity. Additional VR therapies have been shown to enhance functional performance in activities including squatting, standing posture, and energy expenditure. With the commercialization of VR-related products like the Nintendo Wii, many virtual games are readily available for home use. These games are often designed to challenge and train balance, posture, and dynamic movements all of which are critical factors for gait. Thus, VR-based rehabilitation may offer a unique, accessible therapeutic approach to reduce gait impairments and improve dynamic function.

In contrast, tDCS is a neuromodulation technique focused on optimizing existing neural pathways to prolong and/or improve the functional gains achieved by rehabilitation. tDCS is applied through either anodal or cathodal stimulation, which corresponds to excitation or inhibition of the stimulated brain areas, respectively. Anodal stimulation enhances cortical excitability through depolarization, allowing for more spontaneous cell firing, while cathodal stimulation has an inhibitory effect through hyperpolarization. Functionally, this means application of tDCS will influence activity in the area of the brain it targets. Previous research indicates that inhibited cortical input to the corticospinal tract is a possible cause of increased spasticity in CP, so it is reasonable to predict that anodal stimulation would mitigate these symptoms in individuals with spastic CP. The neurophysiological effects of anodal tDCS can also potentiate motor learning through this increase in cortical activity, which is applicable to the treatment of all subtypes of CP. These benefits may translate into functionally improved gait as well.

Eligibility criteria: Inclusion Criteria:

* diagnosed with diplegic CP
* the ages 7-12 years old
* minimum spasticity grades of 1 and 1+ according to modified Ashworth Scale
* Gross motor function classification system (GMFCS) at level I or II.
* Independent ambulation without any assistance or with minimal assistance
* A degree of cognition that allows understanding of the proposed procedures

Exclusion Criteria:

* children who had visual impairments, hearing damage, fixed deformities at lower limbs,
* History of orthopedic surgeries or injection with botulinum toxin in the previous year
* Had metal implants in the skull
* History of epilepsy or other neurological disorders
* or inability to understand the task.

Primary outcomes:
measure: Gait velocity (m/s) (Pre-treatment)
timeFrame: baseline
measure: Gait velocity (m/s) (post-treatment)
timeFrame: 2 weeks
measure: Gait velocity (m/s) (Follow up)
timeFrame: 10 weeks
Secondary outcomes:
measure: Cadence (steps/min) (Pre-treatment)
timeFrame: Baseline
measure: Cadence (steps/min) (post-treatment)
timeFrame: 2 weeks
measure: Cadence (steps/min) (Follow up)
timeFrame: 10 weeks
measure: Stance time (s) (Pre-treatment)
timeFrame: Baseline
measure: Stance time (s) (post-treatment)
timeFrame: 2 weeks
measure: Stance time (s) (Follow up)
timeFrame: 10 weeks
measure: Swing time (s) (Pre-treatment)
timeFrame: Baseline
measure: Swing time (s) (post-treatment)
timeFrame: 2 weeks
measure: Swing time (s) (Follow up)
timeFrame: 10 weeks
measure: Step length (cm) (Pre-treatment)
timeFrame: Baseline
measure: Step length (cm) (post-treatment)
timeFrame: 2 weeks
measure: Step length (cm) (Follow up)
timeFrame: 10 weeks
measure: Stride length (cm) (Pre-treatment)
timeFrame: Baseline
measure: Stride length (cm) (post-treatment)
timeFrame: 2 weeks
measure: Stride length (cm) (Follow up)
timeFrame: 10 weeks
measure: Maximum force (kg) (Pre-treatment)
timeFrame: Baseline
measure: Maximum force (kg) (post-treatment)
timeFrame: 2 weeks
measure: Maximum force (kg) (Follow up)
timeFrame: 10 weeks
measure: Maximum peak pressure (N/cm²) (Pre-treatment)
timeFrame: Baseline
measure: Maximum peak pressure (N/cm²) (post-treatment)
timeFrame: 2 weeks
measure: Maximum peak pressure (N/cm²) (Follow up)
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: outpatient clinic run by the faculty of physical therapy at Cairo University
Study officials:
affiliation: Cairo University, Egypt
name: Hoda Eltalawy, PT, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Beni-Suef University
name: Asmaa Radwan, PT, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rosenbaum P, Paneth N, Leviton A, Goldstein M, Bax M, Damiano D, Dan B, Jacobsson B. A report: the definition and classification of cerebral palsy April 2006. Dev Med Child Neurol Suppl. 2007 Feb;109:8-14.
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: Hamilton A, Wakely L, Marquez J. Transcranial Direct-Current Stimulation on Motor Function in Pediatric Cerebral Palsy: A Systematic Review. Pediatr Phys Ther. 2018 Oct;30(4):291-301. doi: 10.1097/PEP.0000000000000535.
citation: Saleem GT, Crasta JE, Slomine BS, Cantarero GL, Suskauer SJ. Transcranial Direct Current Stimulation in Pediatric Motor Disorders: A Systematic Review and Meta-analysis. Arch Phys Med Rehabil. 2019 Apr;100(4):724-738. doi: 10.1016/j.apmr.2018.10.011. Epub 2018 Nov 7.
citation: Grecco LA, Duarte NA, Zanon N, Galli M, Fregni F, Oliveira CS. Effect of a single session of transcranial direct-current stimulation on balance and spatiotemporal gait variables in children with cerebral palsy: A randomized sham-controlled study. Braz J Phys Ther. 2014 Sep-Oct;18(5):419-27. doi: 10.1590/bjpt-rbf.2014.0053. Epub 2014 Oct 10.
citation: Ravi DK, Kumar N, Singhi P. Effectiveness of virtual reality rehabilitation for children and adolescents with cerebral palsy: an updated evidence-based systematic review. Physiotherapy. 2017 Sep;103(3):245-258. doi: 10.1016/j.physio.2016.08.004. Epub 2016 Sep 27.
citation: Chen Y, Fanchiang HD, Howard A. Effectiveness of Virtual Reality in Children With Cerebral Palsy: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Phys Ther. 2018 Jan 1;98(1):63-77. doi: 10.1093/ptj/pzx107.
citation: Warnier N, Lambregts S, Port IV. Effect of Virtual Reality Therapy on Balance and Walking in Children with Cerebral Palsy: A Systematic Review. Dev Neurorehabil. 2020 Nov;23(8):502-518. doi: 10.1080/17518423.2019.1683907. Epub 2019 Nov 1.
citation: Biffi E, Beretta E, Storm FA, Corbetta C, Strazzer S, Pedrocchi A, Ambrosini E. The Effectiveness of Robot- vs. Virtual Reality-Based Gait Rehabilitation: A Propensity Score Matched Cohort. Life (Basel). 2021 Jun 11;11(6):548. doi: 10.3390/life11060548.
citation: Valenzuela E, Rosa R, Monteiro C, Keniston L, Ayupe K, Fronio J, Chagas P. Intensive Training with Virtual Reality on Mobility in Adolescents with Cerebral Palsy-Single Subject Design. Int J Environ Res Public Health. 2021 Oct 5;18(19):10455. doi: 10.3390/ijerph181910455.
citation: Kim CJ, Son SM. Comparison of Spatiotemporal Gait Parameters between Children with Normal Development and Children with Diplegic Cerebral Palsy. J Phys Ther Sci. 2014 Sep;26(9):1317-9. doi: 10.1589/jpts.26.1317. Epub 2014 Sep 17.
citation: Corsi C, Santos MM, Moreira RFC, Dos Santos AN, de Campos AC, Galli M, Rocha NACF. Effect of physical therapy interventions on spatiotemporal gait parameters in children with cerebral palsy: a systematic review. Disabil Rehabil. 2021 Jun;43(11):1507-1516. doi: 10.1080/09638288.2019.1671500. Epub 2019 Oct 7.