NCT07921095 Additional Effects on tDCS With AOT on Lower Limb Functions on Children With Diplegic CP
| NCT ID | NCT07921095 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Riphah International University |
| Condition | Diplegic Cerebral Palsy |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2026-07-01 |
| Primary Completion | 2026-11-01 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2026-07-01 with a primary completion date of 2026-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Contact & Investigator
Ayesha Bashir
PRINCIPAL INVESTIGATOR
Riphah International University
Frequently Asked Questions
Who can join the NCT07921095 clinical trial?
This trial is open to participants of all sexes, aged 5 Years or older, up to 15 Years, studying Diplegic Cerebral Palsy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07921095 currently recruiting?
Yes, NCT07921095 is actively recruiting participants. Contact the research team at ayesha.bashir@riphah.edu.pk/ for enrollment information.
Where is the NCT07921095 trial being conducted?
This trial is being conducted at Wah, Pakistan.
Who is sponsoring the NCT07921095 clinical trial?
NCT07921095 is sponsored by Riphah International University. The principal investigator is Ayesha Bashir at Riphah International University. The trial plans to enroll 40 participants.
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