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NCT07921095
Additional Effects on tDCS With AOT on Lower Limb Functions on Children With Diplegic CP
Conditions: Diplegic Cerebral Palsy
Sex: All
Ages: 5 Years – 15 Years
Healthy volunteers: No
Phase: NA
Enrollment: 40
Sponsor: Riphah International University
Location: Alam Family Hospital Wah Punjab Province
Summary
The goal of this clinical trial is to evaluate the therapeutic effects of combining active transcranial direct current stimulation (tDCS) with Action Observation Therapy (AOT) in pediatric patients diagnosed with spastic Cerebral Palsy. The main questions it aims to answer are:
1. Does combining tDCS with AOT yield significantly greater improvements in gross motor function (measured by GMFM-88) compared to AOT alone?
2. Does active tDCS paired with AOT lead to greater reductions in spasticity (MAS) and improvements in walking speed (10MWT) at 6 weeks post-intervention?
Researchers will compare participants receiving active tDCS plus AOT against a control group receiving sham tDCS plus AOT to isolate the synergistic effects of active brain stimulation.
Participants will:
1. Complete baseline clinical evaluations including gross motor, spasticity, and gait assessments.
2. Undergo scheduled intervention sessions consisting of tDCS administration combined with video-based Action Observation Therapy.
3. Attend follow-up assessment sessions at the end of the intervention period and 6 weeks post-intervention.
Eligibility Criteria
Inclusion Criteria:
1. Participants diagnosed with spastic diplegic cerebral palsy with a Modified Ashworth Scale (MAS) score of 2
2. Age between 6 to 12 years old
3. Participants classified as Communication Function Classification System (CFCS) Level II
4. Participant with CFCS Level II
Exclusion Criteria:
1. Presence of uncontrolled epilepsy (any seizure within the past 6 months).
2. Implanted metallic or electronic devices (e.g., pacemaker, cochlear implant, deep brain stimulator).
3. Severe dystonia, ataxia, or predominant weakness interfering with upper limb or lower limb function.
4. Severe visual impairment (not correctable with aids) preventing participation in action observation tasks.
5. Botulinum toxin injections in the affected limb(s) within the past 6 months or planned during study period.
6. Orthopedic surgery to the affected limb(s) within the past 12 months or planned during study period.
7. Skin conditions, lesions, or infections at electrode placement sites.
8. Current use of medications significantly affecting cortical excitability (e.g., high-dose benzodiazepines, anticonvulsants), unless cleared by neurologist.
9. Participation in another interventional clinical trial within the past 3 months.
10. Any medical or psychiatric condition that, in the investigator's judgment, makes participation unsafe or interferes with study outcomes.
Source: ClinicalTrials.gov (NCT07921095). StuddyBuddy aggregates publicly available trial information.