Loading search results

Outcome Measures

Primary Outcomes (1)

Baseline and post- intervention Fugl-Meyer motor assessment
The Fugl-Meyer motor assessment (FM) will be the primary outcome measure. The scale is a reliable and valid measure for upper limb impairment among stroke patients19. The score ranges from 0-66, score less than 18 are considered severe to moderate functional impairment. The scale takes 20 minutes to complete.
8 Months

Secondary Outcomes (2)

Beiseline and post- intervention Motricity Index
8 Months
Baseline and post- intervention Modified Barthel Index
8 Months

Study Arms (2)

Experimental group

EXPERIMENTAL

Transcranial direct stimulation + virtual related group: Brain stimulator v3.0 will be used to deliver 1.5 mA current over the scalp corresponding to the primary motor cortex. The current will be delivered via two surface electrodes 5 × 5 cm placed on the scalp Virtual reality (KVR) is the use of a computer interface involving upper limb activity in pediatric rehabilitation. VR creates an artificial environment, presented to the user through appropriate sensory stimulations.

Device: Brain stimulator v3.0

Control group

SHAM COMPARATOR

Sham Transcranial direct stimulation Group + virtual related group; The sham set-up will follow a similar protocol as the experimental group but the intensity of the current will be ceased after 30 seconds of stimulation. Participants in the Sham group will feel the identical sensation as the experimental group and will be unable to differentiate between actual and sham tDCS such procedure is validated in earlier studies.

Other: Sham Comparator: Control group

Interventions

Brain stimulator v3.0Device

Brain stimulator v3.0 will be used to deliver 1.5 mA current over the scalp corresponding to the primary motor cortex. The current will be delivered via two surface electrodes 5 × 5 cm placed on the scalp, validated by the previous research

Experimental group

Sham Comparator: Control groupOther

The sham set-up will follow a similar protocol as the experimental group but the intensity of the current will be ceased after 30 seconds of stimulation. Participants in the Sham group will feel the identical sensation as the experimental group and will be unable to differentiate between actual and sham tDCS such procedure is validated in earlier studies

Eligibility Criteria

Age5 Years - 12 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

You may qualify if:

The congenital stroke survivors with mild to moderate degree of upper limb disability on the Brunnstrom recovery scale16. The scores from 3-4 are considered moderate and 5-6 as a mild degree of upper-limb disability.
Age 5-12 years.

Study Design

Study Type

interventional

Phase

not applicable

Allocation

RANDOMIZED

Masking

TRIPLE

Who Masked

PARTICIPANT, CARE PROVIDER, INVESTIGATOR

Masking Details

Children will be randomly allocated to one of the two groups by the lottery method. The researcher involved in randomization will not be involved in the assessment or treatment of the participants. The participants and therapists will also be blinded about the subjects allocated to a group by assigning a unique random number to the participants. Pre and post assessment will be performed by the same therapist. The therapist involved in the treatment is blinded about the treatment received by other groups. Each participant will undergo 3 weeks of treatment, 4 days a week. The total number of treatment sessions for each participant will be 12. Each participant will be assessed on the baseline, 2nd week, 3rd week and on 8th week follow up.

Purpose

TREATMENT

Intervention Model

PARALLEL

Model Details: Group 1: Transcranial direct stimulation + virtual related group: The group will receive the tCDS and VR Group 2: Sham Transcranial direct stimulation Group + virtual related group: The groups will only receive sham tCDS and VR.

Sponsor Type

OTHER

Responsible Party

PRINCIPAL INVESTIGATOR

PI Title

Prinicipal investigator

Effect of Transcranial Direct Current Stimulation on Upper Extremity of Children With Hemiparesis

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

Experimental group

Control group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

Experimental group

Control group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations