Cerebral PalsyNCT05670522
Transcranial Direct Current Stimulation Versus Virtual Reality on Gait in Children With Spastic Diplegia
A study testing Transcranial direct current stimulation and Virtual reality in people with Cerebral Palsy, run by Beni-Suef University at 1 site in Egypt.
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… Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Transcranial direct current stimulation and Virtual reality
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Nov 2020to 14 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
outpatient clinic run by the faculty of physical therapy at Cairo University
Giza, 12624
About this study
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.
Read the 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.
- Conditions
- Cerebral Palsy
- Being tested
- Transcranial direct current stimulation, Virtual reality
- Keywords
- Transcranial direct current stimulation, virtual reality, gait intervention, cerebral palsy
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial direct current stimulationDevice
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 realityDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Transcranial direct current stimulation group | Experimental | Children assigned to the transcranial direct current stimulation group received active transcranial direct current at their primary motor cortex (Active dose 11, ser. No 13070350, Active Tek Inc., USA). Stimulation was conducted at an intensity of 1 mA for 20 min per session, 5 times/week for 2 successive weeks (total of 10 sessions). 1 mA was shown to be appropriate in children's investigations. The anode (+) was positioned on the midline sagittal plane of the skull, corresponding to the motor area of lower limbs, and the cathode (-) was positioned over the inion. In addition to their assigned intervention, the children received the standard-of-care gait training. During the two-week intervention phase, gait training was administered immediately after each intervention session. Training was delivered in one hour increments 5 times/week for those first two weeks, then 3 times/week for the next 10 weeks. Receives: Device: Transcranial direct current stimulation |
| Virtual reality group | Experimental | Children assigned to the virtual reality group received virtual balance training using Nintendo Wii and Wii Balance Board, with a custom training program developed from activities on the Wii Fit Plus game. Training was conducted for 30 minutes, 5 sessions/week for 2 successive weeks (total of 10 sessions). Two sessions with Wii Fit Plus were conducted before the treatment protocol to help the children familiarize with the VR setup. In addition to their assigned intervention, the children received the standard-of-care gait training. During the two-week intervention phase, gait training was administered immediately after each intervention session. Training was delivered in one hour increments 5 times/week for those first two weeks, then 3 times/week for the next 10 weeks. Receives: Device: Virtual reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline
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.
Measured: 2 weeks
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.
Measured: 10 weeks
Secondary outcomes (21)
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.
Measured: Baseline
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.
Measured: 2 weeks
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.
Measured: 10 weeks
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.
Measured: Baseline
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.
Measured: 2 weeks
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.
Measured: 10 weeks
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.
Measured: Baseline
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.
Measured: 2 weeks
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.
Measured: 10 weeks
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.
Measured: Baseline
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.
Measured: 2 weeks
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.
Measured: 10 weeks
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.
Measured: Baseline
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.
Measured: 2 weeks
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.
Measured: 10 weeks
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.
Measured: Baseline
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.
Measured: 2 weeks
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.
Measured: 10 weeks
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.
Measured: Baseline
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.
Measured: 2 weeks
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.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2023
- Study start11 Nov 2020
- Primary completion14 Aug 2021
- Study completion14 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Collaborators
- Shirley Ryan AbilityLab, Cairo University
- Responsible party
- Principal investigator, Asmaa Radwan, Beni-Suef University
- Investigators
- Hoda Eltalawy, PT, PhD, Principal investigator, Cairo University, EgyptAsmaa Radwan, PT, MSc, Principal investigator, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05670522
- Sponsor's protocol ID
- tDCS verus VR
- Status last verified
- Jan 2023
- First submitted
- 6 Dec 2022
- Last updated
- 11 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 17370477Novak 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.
PubMed 32086598Hamilton 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.
PubMed 30199513Saleem 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.
PubMed 30414398Grecco 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.
PubMed 25372004Ravi 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.
PubMed 28109566Chen 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.
PubMed 29088476Warnier 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.
PubMed 31674852Biffi 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.
PubMed 34208009Valenzuela 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.
PubMed 34639757Kim 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.
PubMed 25276007Corsi 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.
PubMed 31588810
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Direct Current Stimulation Versus Virtual Reality on Gait in Children With Spastic Diplegia
- ClinicalTrials.gov ID
- NCT05670522
- Acronym / sponsor ID
- tDCS verus VR
- Conditions
- Cerebral Palsy
- Keywords
- Transcranial direct current stimulation, virtual reality, gait intervention, cerebral palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Collaborators
- Shirley Ryan AbilityLab, Cairo University
- Study start
- 11 Nov 2020 (actual)
- Primary completion
- 14 Aug 2021 (actual)
- Study completion
- 14 Aug 2021 (actual)
- First posted
- 4 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcranial direct current stimulation group | Experimental | Device: Transcranial direct current stimulationChildren assigned to the transcranial direct current stimulation group received active transcranial direct current at their primary motor cortex (Active dose 11, ser. No 13070350, Active Tek Inc., USA). Stimulation was conducted at an intensity of 1 mA for 20 min per session, 5 times/week for 2 successive weeks (total of 10 sessions). 1 mA was shown to be appropriate in children's investigations. The anode (+) was positioned on the midline sagittal plane of the skull, corresponding to the motor area of lower limbs, and the cathode (-) was positioned over the inion. In addition to their assigned intervention, the children received the standard-of-care gait training. During the two-week intervention phase, gait training was administered immediately after each intervention session. Training was delivered in one hour increments 5 times/week for those first two weeks, then 3 times/week for the next 10 weeks. |
| Virtual reality group | Experimental | Device: Virtual realityChildren assigned to the virtual reality group received virtual balance training using Nintendo Wii and Wii Balance Board, with a custom training program developed from activities on the Wii Fit Plus game. Training was conducted for 30 minutes, 5 sessions/week for 2 successive weeks (total of 10 sessions). Two sessions with Wii Fit Plus were conducted before the treatment protocol to help the children familiarize with the VR setup. In addition to their assigned intervention, the children received the standard-of-care gait training. During the two-week intervention phase, gait training was administered immediately after each intervention session. Training was delivered in one hour increments 5 times/week for those first two weeks, then 3 times/week for the next 10 weeks. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial direct current stimulationTranscranial 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. | Device | Transcranial direct current stimulation group |
| Virtual realityVirtual 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. | Device | Virtual reality group |
Primary outcome
Gait velocity (m/s) (Pre-treatment)
Time frame: baseline
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.
Gait velocity (m/s) (post-treatment)
Time frame: 2 weeks
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.
Gait velocity (m/s) (Follow up)
Time frame: 10 weeks
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.
21 secondary outcomes
Cadence (steps/min) (Pre-treatment)
Time frame: Baseline
Cadence (steps/min) (post-treatment)
Time frame: 2 weeks
Cadence (steps/min) (Follow up)
Time frame: 10 weeks
Stance time (s) (Pre-treatment)
Time frame: Baseline
Stance time (s) (post-treatment)
Time frame: 2 weeks
Stance time (s) (Follow up)
Time frame: 10 weeks
Swing time (s) (Pre-treatment)
Time frame: Baseline
Swing time (s) (post-treatment)
Time frame: 2 weeks
Swing time (s) (Follow up)
Time frame: 10 weeks
Step length (cm) (Pre-treatment)
Time frame: Baseline
Step length (cm) (post-treatment)
Time frame: 2 weeks
Step length (cm) (Follow up)
Time frame: 10 weeks
Stride length (cm) (Pre-treatment)
Time frame: Baseline
Stride length (cm) (post-treatment)
Time frame: 2 weeks
Stride length (cm) (Follow up)
Time frame: 10 weeks
Maximum force (kg) (Pre-treatment)
Time frame: Baseline
Maximum force (kg) (post-treatment)
Time frame: 2 weeks
Maximum force (kg) (Follow up)
Time frame: 10 weeks
Maximum peak pressure (N/cm²) (Pre-treatment)
Time frame: Baseline
Maximum peak pressure (N/cm²) (post-treatment)
Time frame: 2 weeks
Maximum peak pressure (N/cm²) (Follow up)
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2023.
- Background: PubMed 17370477Rosenbaum 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.
- Background: PubMed 32086598Novak 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.
- Background: PubMed 30199513Hamilton 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.
- Background: PubMed 30414398Saleem 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.
- Background: PubMed 25372004Grecco 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.
- Background: PubMed 28109566Ravi 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.
- Background: PubMed 29088476Chen 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.
- Background: PubMed 31674852Warnier 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.
- Background: PubMed 34208009Biffi 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.
- Background: PubMed 34639757Valenzuela 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.
- Background: PubMed 25276007Kim 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.
- Background: PubMed 31588810Corsi 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.
Related trials for Cerebral Palsy
Not yet recruitingObservational study
Changes in Land-Based Motor Function After Routine Hydrotherapy in Children With Cerebral Palsy
Cerebral Palsy
Not yet recruiting
EFFECT OF ROBOTIC GLOVES TRAINING ON UPPER LIMB COORDINATION, SELECTIVE MOTOR CONTROL AND ACTIVITIES OF DAILY LIVING IN CHILDREN WITH HEMIPARETIC CEREBRAL PALSY.
Hemiplegic Cerebral Palsy
Recruiting
Combined Popliteal and Adductor Canal Blocks for Postoperative Analgesia in Children With Cerebral Palsy
Cerebral Palsy, Postoperative Pain
Not yet recruiting
Ayres Sensory Integration Intervention for Children With Cerebral Palsy
Cerebral Palsy (CP)
Recruiting
Paired Non-invasive VNS in Adolescent Cerebral Palsy Rehabilitation
Cerebral Palsy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hoda Eltalawy, PT, PhD principal investigator
Cairo University, Egypt
Asmaa Radwan, PT, MSc principal investigator
Beni-Suef University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial direct current stimulation and Virtual reality in people with Cerebral Palsy, run by Beni-Suef University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait velocity (m/s) (Pre-treatment) (time frame: baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05670522, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2023; AzTrials last refreshed its copy on 1 Nov 2026.