Transcranial Direct Current Stimulation Versus Virtual Reality on Gait in Children With Spastic Diplegia

NCT05670522 | Completed DMC

• 1 other identifier: tDCS verus VR
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Keywords

Transcranial direct current stimulation; virtual reality; gait intervention; cerebral palsy

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (21)

• Cadence (steps/min) (Pre-treatment)

  Baseline

• Cadence (steps/min) (post-treatment)

  2 weeks

• Cadence (steps/min) (Follow up)

  10 weeks

• Stance time (s) (Pre-treatment)

  Baseline

• Stance time (s) (post-treatment)

  2 weeks

Study Arms (2)

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.

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.

Device: Virtual reality

Interventions

Transcranial direct current stimulation DEVICE

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.

Transcranial direct current stimulation group

Virtual reality DEVICE

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.

Virtual reality group

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beni-Suef University: lead
• Shirley Ryan AbilityLab: collaborator
• Cairo University: collaborator

Study Sites (1)

outpatient clinic run by the faculty of physical therapy at Cairo University

Giza, 12624, Egypt

Location

Related Publications (12)

• 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.

  PMID: 17370477 BACKGROUND

• 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.

  PMID: 32086598 BACKGROUND

• 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.

  PMID: 30199513 BACKGROUND

• 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.

  PMID: 30414398 BACKGROUND

• 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.

  PMID: 25372004 BACKGROUND

• 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.

  PMID: 28109566 BACKGROUND

• 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.

  PMID: 29088476 BACKGROUND

• 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.

  PMID: 31674852 BACKGROUND

• 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.

  PMID: 34208009 BACKGROUND

• 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.

  PMID: 34639757 BACKGROUND

• 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.

  PMID: 25276007 BACKGROUND

• 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.

  PMID: 31588810 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Hoda Eltalawy, PT, PhD

  Cairo University, Egypt

  PRINCIPAL INVESTIGATOR

• Asmaa Radwan, PT, MSc

  Beni-Suef University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: December 6, 2022
• First Posted: January 4, 2023
• Study Start: November 11, 2020
• Primary Completion: August 14, 2021
• Study Completion: August 14, 2021
• Last Updated: January 11, 2023

Record last verified: 2023-01

Locations

EG (1)