tDCS and Bi-manual Training in Cerebral Palsy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-17
SponsorRiphah International University
About this trial
Unilateral spastic cerebral palsy (USCP) is the most common subtype of cerebral palsy and significantly limits upper limb function. Traditional therapies such as constraint-induced movement therapy (CIMT) and bimanual intensive training offer limited benefits. Pharmacologic treatments often produce behavioral side effects and do not address underlying neuro-plastic deficits. There is an unmet need for safe, effective, non-invasive interventions targeting motor recovery through cortical modulation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Children aged 6-17 years with unilateral spastic CP
Wrist extension ≥ 20°, MCP/PIP joints ≥ 10°
Disqualifiers
Any other neurological disorders
An orthopedic condition affecting the participation in UE activities.
Unable to understand the command.
Trial design
Design model
Crossover
Treatments tested in this trial
Anodal tDCS
Other interventionAnodal tDCS will be applied to the affected motor cortex area for 20 minutes along with the bimanual motor training. The intervention will be applied for 5 days in 1-2 weeks.
Sham tDCS
Other interventionSham tDCS will be applied to the affected motor cortex for 20 minutes along with the bimanual motor training. The intervention will be applied for 5 days in 1-2 weeks.
Treatment groups
15 Participants
are divided into 2 treatment groupsGroup A: Anodal tDCSActive comparator 1 intervention
Group B: Sham tDCSSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
ABILHAND-KIDS
ABILHAND-Kids is used to measure a child's manual ability (using their hands/arms) for daily tasks, especially for children with conditions like cerebral palsy or brachial plexus birth injury.
Time frame
baseline, after 1 week of interventionSecondary outcomes
1
Box and Block test
The Box and Block Test (BBT) assesses gross manual dexterity in kids with Cerebral Palsy (CP) aged 6-15 by having them move as many 1-inch blocks as possible from one box side to another in 60 seconds, one block at a time, testing each hand separately
Time frame
Baseline, after 1 week of intervention2
Movement-related cortical potentials
Movement-related cortical potentials (MRCP) with the help of EEG: peak amplitude, onset latency, and area under the curve at Cz/C3/C4.
Time frame
baseline, 1 week after intervention3
Event-related desynchronization (ERD) / synchronization (ERS)
Event-related desynchronization (ERD) / synchronization (ERS) with the help of EEG: mu (8-13 Hz) and beta (13-30 Hz) ERD magnitude and timing during movement.
Time frame
baseline, 1 week after intervention4
Resting-state sensorimotor beta/mu power
Resting-state sensorimotor beta/mu power with the help of EEG: absolute and relative power at C3/C4 and central ROI.
Time frame
baseline, 1 week after interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Riphah International University
Lead sponsor
King Fahad Specialist Hospital Dammam
Collaborator
Source ClinicalTrials.gov
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