Additional Effects on tDCS With AOT on Lower Limb Functions on Children With Diplegic CP (tDCS)

November 5, 2026 updated by: Riphah International University

Additional Effects on Transcranial Direct Current Stimulation (tDCS) With Action Observation Therapy on Lower Limb Functions on Children With Diplegic Cerebral Palsy

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Ayesha Bashir

Study Locations

  • Pakistan
    • Punjab Province
      • Wah, Punjab Province, Pakistan, 47000
        • Recruiting
        • Alam Family Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Experimental Group

TDCS+ Action observation Therapy
Other: Action Observation Therapy

Observation of video recorded

Device: Transcranial Direct Current Stimulation

Active Anodal tDCS (1-1.5 mA)
Sham Comparator: Control Group

Sham TDCs + Action Observation Therapy
Other: Action Observation Therapy

Observation of video recorded

Device: Sham TDCs

Sham TDCs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gross Motor Functional Measurement (GMFM-88)
Time Frame: Baseline and 6 months (post - intervention)

Assessment of Gross Motor Capacity focusing on standing
Baseline and 6 months (post - intervention)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
10-Meter Walk Test (10MWT)
Time Frame: Baseline and 6 weeks (post-intervention)

Measures walking speed in meters per second over 10 meters
Baseline and 6 weeks (post-intervention)
Modified Ashworth Scale (MAS) - Muscle tone
Time Frame: Baseline and 6 weeks (post-intervention)

Evaluate muscle spasticity in lower limb joints
Baseline and 6 weeks (post-intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

  • Principal Investigator: Ayesha Bashir, Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2026

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

November 2, 2026

First Submitted That Met QC Criteria

November 5, 2026

First Posted (Actual)

November 6, 2026

Study Record Updates

Last Update Posted (Actual)

November 6, 2026

Last Update Submitted That Met QC Criteria

November 5, 2026

Last Verified

November 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RCRAHS-ISB/REC/MS-PT/02470

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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