Cerebral Palsy Clinical Trial
Official title:
Transcranial Direct Current Stimulation Versus Virtual Reality on Gait in Children With Spastic Diplegia
Verified date | January 2023 |
Source | Beni-Suef University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Egypt | outpatient clinic run by the faculty of physical therapy at Cairo University | Giza |
Lead Sponsor | Collaborator |
---|---|
Beni-Suef University | Cairo University, Shirley Ryan AbilityLab |
Egypt,
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* Note: There are 12 references in all — Click here to view all references
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 |
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