Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05670522
Other study ID # tDCS verus VR
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 11, 2020
Est. completion date August 14, 2021

Study information

Verified date January 2023
Source Beni-Suef University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date August 14, 2021
Est. primary completion date August 14, 2021
Accepts healthy volunteers No
Gender All
Age group 7 Years to 12 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Transcranial direct current stimulation
Transcranial direct-current stimulation (tDCS), over the motor cortex, is a potential therapy option for motor control deficits in children with CP. The application of tDCS involves positioning 2 rubber electrodes sheathed in saline-soaked pads onto the scalp, held in place by a rubber strap. Low-intensity, direct-current, of 1 to 2 mA, is delivered to cortical areas from the device. The standard-of-care gait training included various gait training and balance tasks as well as resistive exercises and passive stretching as necessary. Task-specific gait exercises included: walking in a closed indoor environment, walking in an open indoor environment, walking on various floor surfaces, and climbing stairs up and down without assistance. The children also performed dynamic balance exercises by walking on a balance board.
Virtual reality
Virtual reality rehabilitation is an emerging therapy for motor rehabilitation of children with CP. The therapy is provided through a computer-simulated environment where they interact with real-world-like objects and events through sight, sound, and touch. The Wii Remote was used as the interactive interface, and standard computer/television screens were used as the display hardware. Therefore, VR therapy was of the non-immersive type. The standard-of-care gait training included various gait training and balance tasks as well as resistive exercises and passive stretching as necessary. Task-specific gait exercises included: walking in a closed indoor environment, walking in an open indoor environment, walking on various floor surfaces, and climbing stairs up and down without assistance. The children also performed dynamic balance exercises by walking on a balance board.

Locations

Country Name City State
Egypt outpatient clinic run by the faculty of physical therapy at Cairo University Giza

Sponsors (3)

Lead Sponsor Collaborator
Beni-Suef University Cairo University, Shirley Ryan AbilityLab

Country where clinical trial is conducted

Egypt, 

References & Publications (12)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. Erratum In: Dev Med Child Neurol. 2007 Jun;49(6):480. — View 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. — View 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. — View 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. — View Citation

* Note: There are 12 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Gait velocity (m/s) (Pre-treatment) Gait velocity was measured using Walkway Pressure Measurement System. This system consists of a digital mat inserted in a wooden walkway, equipped with sensors and a pressure recording system at a sampling resolution up to 185 Hz. A computer with the soft-ware (version 7) and transmission hardware were used to download the data. Three trials were then completed to collect the gait parameters for analysis. baseline
Primary Gait velocity (m/s) (post-treatment) Gait velocity was measured using Walkway Pressure Measurement System. This system consists of a digital mat inserted in a wooden walkway, equipped with sensors and a pressure recording system at a sampling resolution up to 185 Hz. A computer with the soft-ware (version 7) and transmission hardware were used to download the data. Three trials were then completed to collect the gait parameters for analysis. 2 weeks
Primary Gait velocity (m/s) (Follow up) Gait velocity was measured using Walkway Pressure Measurement System. This system consists of a digital mat inserted in a wooden walkway, equipped with sensors and a pressure recording system at a sampling resolution up to 185 Hz. A computer with the soft-ware (version 7) and transmission hardware were used to download the data. Three trials were then completed to collect the gait parameters for analysis. 10 weeks
Secondary Cadence (steps/min) (Pre-treatment) Cadence was measured using Walkway Pressure Measurement System. This system consists of a digital mat inserted in a wooden walkway, equipped with sensors and a pressure recording system at a sampling resolution up to 185 Hz. A computer with soft-ware (version 7) and transmission hardware were used to download the data. Three trials were then completed to collect the gait parameters for analysis. Baseline
Secondary Cadence (steps/min) (post-treatment) Cadence was measured using Walkway Pressure Measurement System. This system consists of a digital mat inserted in a wooden walkway, equipped with sensors and a pressure recording system at a sampling resolution up to 185 Hz. A computer with soft-ware (version 7) and transmission hardware were used to download the data. Three trials were then completed to collect the gait parameters for analysis. 2 weeks
Secondary Cadence (steps/min) (Follow up) Cadence was measured using Walkway Pressure Measurement System. This system consists of a digital mat inserted in a wooden walkway, equipped with sensors and a pressure recording system at a sampling resolution up to 185 Hz. A computer with soft-ware (version 7) and transmission hardware were used to download the data. Three trials were then completed to collect the gait parameters for analysis. 10 weeks
Secondary Stance time (s) (Pre-treatment) Stance time was measured using Walkway Pressure Measurement System. This system consists of a digital mat inserted in a wooden walkway, equipped with sensors and a pressure recording system at a sampling resolution up to 185 Hz. A computer with soft-ware (version 7) and transmission hardware were used to download the data. Three trials were then completed to collect the gait parameters for analysis. Baseline
Secondary Stance time (s) (post-treatment) Stance time was measured using Walkway Pressure Measurement System. This system consists of a digital mat inserted in a wooden walkway, equipped with sensors and a pressure recording system at a sampling resolution up to 185 Hz. A computer with soft-ware (version 7) and transmission hardware were used to download the data. Three trials were then completed to collect the gait parameters for analysis. 2 weeks
Secondary Stance time (s) (Follow up) Stance time was measured using Walkway Pressure Measurement System. This system consists of a digital mat inserted in a wooden walkway, equipped with sensors and a pressure recording system at a sampling resolution up to 185 Hz. A computer with soft-ware (version 7) and transmission hardware were used to download the data. Three trials were then completed to collect the gait parameters for analysis. 10 weeks
Secondary Swing time (s) (Pre-treatment) Swing time was measured using Walkway Pressure Measurement System. This system consists of a digital mat inserted in a wooden walkway, equipped with sensors and a pressure recording system at a sampling resolution up to 185 Hz. A computer with soft-ware (version 7) and transmission hardware were used to download the data. Three trials were then completed to collect the gait parameters for analysis. Baseline
Secondary Swing time (s) (post-treatment) Swing time was measured using Walkway Pressure Measurement System. This system consists of a digital mat inserted in a wooden walkway, equipped with sensors and a pressure recording system at a sampling resolution up to 185 Hz. A computer with soft-ware (version 7) and transmission hardware were used to download the data. Three trials were then completed to collect the gait parameters for analysis. 2 weeks
Secondary Swing time (s) (Follow up) Swing time was measured using Walkway Pressure Measurement System. This system consists of a digital mat inserted in a wooden walkway, equipped with sensors and a pressure recording system at a sampling resolution up to 185 Hz. A computer with soft-ware (version 7) and transmission hardware were used to download the data. Three trials were then completed to collect the gait parameters for analysis. 10 weeks
Secondary Step length (cm) (Pre-treatment) Step length was measured using Walkway Pressure Measurement System. This system consists of a digital mat inserted in a wooden walkway, equipped with sensors and a pressure recording system at a sampling resolution up to 185 Hz. A computer with soft-ware (version 7) and transmission hardware were used to download the data. Three trials were then completed to collect the gait parameters for analysis. Baseline
Secondary Step length (cm) (post-treatment) Step length was measured using Walkway Pressure Measurement System. This system consists of a digital mat inserted in a wooden walkway, equipped with sensors and a pressure recording system at a sampling resolution up to 185 Hz. A computer with soft-ware (version 7) and transmission hardware were used to download the data. Three trials were then completed to collect the gait parameters for analysis. 2 weeks
Secondary Step length (cm) (Follow up) Step length was measured using Walkway Pressure Measurement System. This system consists of a digital mat inserted in a wooden walkway, equipped with sensors and a pressure recording system at a sampling resolution up to 185 Hz. A computer with soft-ware (version 7) and transmission hardware were used to download the data. Three trials were then completed to collect the gait parameters for analysis. 10 weeks
Secondary Stride length (cm) (Pre-treatment) Stride length was measured using Walkway Pressure Measurement System. This system consists of a digital mat inserted in a wooden walkway, equipped with sensors and a pressure recording system at a sampling resolution up to 185 Hz. A computer with soft-ware (version 7) and transmission hardware were used to download the data. Three trials were then completed to collect the gait parameters for analysis. Baseline
Secondary Stride length (cm) (post-treatment) Stride length was measured using Walkway Pressure Measurement System. This system consists of a digital mat inserted in a wooden walkway, equipped with sensors and a pressure recording system at a sampling resolution up to 185 Hz. A computer with soft-ware (version 7) and transmission hardware were used to download the data. Three trials were then completed to collect the gait parameters for analysis. 2 weeks
Secondary Stride length (cm) (Follow up) Stride length was measured using Walkway Pressure Measurement System. This system consists of a digital mat inserted in a wooden walkway, equipped with sensors and a pressure recording system at a sampling resolution up to 185 Hz. A computer with soft-ware (version 7) and transmission hardware were used to download the data. Three trials were then completed to collect the gait parameters for analysis. 10 weeks
Secondary Maximum force (kg) (Pre-treatment) Maximum force was measured using Walkway Pressure Measurement System. This system consists of a digital mat inserted in a wooden walkway, equipped with sensors and a pressure recording system at a sampling resolution up to 185 Hz. A computer with soft-ware (version 7) and transmission hardware were used to download the data. Three trials were then completed to collect the gait parameters for analysis. Baseline
Secondary Maximum force (kg) (post-treatment) Maximum force was measured using Walkway Pressure Measurement System. This system consists of a digital mat inserted in a wooden walkway, equipped with sensors and a pressure recording system at a sampling resolution up to 185 Hz. A computer with soft-ware (version 7) and transmission hardware were used to download the data. Three trials were then completed to collect the gait parameters for analysis. 2 weeks
Secondary Maximum force (kg) (Follow up) Maximum force was measured using Walkway Pressure Measurement System. This system consists of a digital mat inserted in a wooden walkway, equipped with sensors and a pressure recording system at a sampling resolution up to 185 Hz. A computer with soft-ware (version 7) and transmission hardware were used to download the data. Three trials were then completed to collect the gait parameters for analysis. 10 weeks
Secondary Maximum peak pressure (N/cm²) (Pre-treatment) Maximum peak pressure was measured using Walkway Pressure Measurement System. This system consists of a digital mat inserted in a wooden walkway, equipped with sensors and a pressure recording system at a sampling resolution up to 185 Hz. A computer with the soft-ware (version 7) and transmission hardware were used to download the data. Three trials were then completed to collect the gait parameters for analysis. Baseline
Secondary Maximum peak pressure (N/cm²) (post-treatment) Maximum peak pressure was measured using Walkway Pressure Measurement System. This system consists of a digital mat inserted in a wooden walkway, equipped with sensors and a pressure recording system at a sampling resolution up to 185 Hz. A computer with soft-ware (version 7) and transmission hardware were used to download the data. Three trials were then completed to collect the gait parameters for analysis. 2 weeks
Secondary Maximum peak pressure (N/cm²) (Follow up) Maximum peak pressure was measured using Walkway Pressure Measurement System. This system consists of a digital mat inserted in a wooden walkway, equipped with sensors and a pressure recording system at a sampling resolution up to 185 Hz. A computer with soft-ware (version 7) and transmission hardware were used to download the data. Three trials were then completed to collect the gait parameters for analysis. 10 weeks
See also
  Status Clinical Trial Phase
Recruiting NCT05317234 - Genetic Predisposition in Cerebral Palsy N/A
Recruiting NCT05576948 - Natural History of Cerebral Palsy Prospective Study
Completed NCT04119063 - Evaluating Wearable Robotic Assistance on Gait Early Phase 1
Completed NCT03264339 - The Small Step Program - Early Intervention for Children With High Risk of Developing Cerebral Palsy N/A
Completed NCT05551364 - Usability and Effectiveness of the ATLAS2030 Exoskeleton in Children With Cerebral Palsy N/A
Completed NCT03902886 - Independent Walking Onset of Children With Cerebral Palsy
Recruiting NCT05571033 - Operant Conditioning of the Soleus Stretch Reflex in Adults With Cerebral Palsy N/A
Not yet recruiting NCT04081675 - Compliance in Children With Cerebral Palsy Supplied With AFOs
Completed NCT02167022 - Intense Physiotherapies to Improve Function in Young Children With Cerebral Palsy N/A
Completed NCT04012125 - The Effect of Flexible Thoracolumbar Brace on Scoliosis in Cerebral Palsy N/A
Enrolling by invitation NCT05619211 - Piloting Movement-to-Music With Arm-based Sprint-Intensity Interval Training Among Children With Physical Disabilities Phase 1
Completed NCT04489498 - Comparison of Somatometric Characteristics Between Cerebral Palsy and Normal Children, Cross-sectional, Multi Center Study
Completed NCT03677193 - Biofeedback-enhanced Interactive Computer-play for Youth With Cerebral Palsy N/A
Recruiting NCT06450158 - Robot-assisted Training in Children With CP N/A
Completed NCT04093180 - Intensive Neurorehabilitation for Cerebral Palsy N/A
Completed NCT02909127 - The Pediatric Eating Assessment Tool
Not yet recruiting NCT06377982 - Human Umbilical Cord Blood Infusion in Patients With Cerebral Palsy Phase 1
Not yet recruiting NCT06007885 - Examining Capacity Building of Youth With Physical Disabilities to Pursue Participation Following the PREP Intervention. N/A
Not yet recruiting NCT03183427 - Corpus Callosum Size in Patients With Pineal Cyst N/A
Active, not recruiting NCT03078621 - Bone Marrow-Derived Stem Cell Transplantation for the Treatment of Cerebral Palsy Phase 1/Phase 2