Diplegic Cerebral PalsytDCSNCT07921095
Additional Effects on tDCS With AOT on Lower Limb Functions on Children With Diplegic CP
A study testing Action Observation Therapy and Transcranial Direct Current Stimulation in people with Diplegic Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 15 years
- Conditions the study is for
- Diplegic Cerebral Palsy
- What is being tested?
- Action Observation Therapy and Transcranial Direct Current Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jul 2026to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Participants diagnosed with spastic diplegic cerebral palsy with a Modified Ashworth Scale (MAS) score of 2
- Age between 6 to 12 years old
- Participants classified as Communication Function Classification System (CFCS) Level II
- Participant with CFCS Level II
Who cannot join
- Presence of uncontrolled epilepsy (any seizure within the past 6 months).
- Implanted metallic or electronic devices (e.g., pacemaker, cochlear implant, deep brain stimulator).
- Severe dystonia, ataxia, or predominant weakness interfering with upper limb or lower limb function.
- Severe visual impairment (not correctable with aids) preventing participation in action observation tasks.
- Botulinum toxin injections in the affected limb(s) within the past 6 months or planned during study period.
- Orthopedic surgery to the affected limb(s) within the past 12 months or planned during study period.
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- Skin conditions, lesions, or infections at electrode placement sites.
- Current use of medications significantly affecting cortical excitability (e.g., high-dose benzodiazepines, anticonvulsants), unless cleared by neurologist.
- Participation in another interventional clinical trial within the past 3 months.
- Any medical or psychiatric condition that, in the investigator's judgment, makes participation unsafe or interferes with study outcomes.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ayesha Bashir contact
Pakistan1 site, 1 recruiting
- Recruiting
Alam Family Hospital
Wah, Punjab Province, 47000
About this study
Official title: 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:
- Does combining tDCS with AOT yield significantly greater improvements in gross motor function (measured by GMFM-88) compared to AOT alone?
- Does active tDCS paired with AOT lead to greater reductions in spasticity (MAS) and improvements in walking speed (10MWT) at 6 weeks post-intervention?
Read more
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:
- Complete baseline clinical evaluations including gross motor, spasticity, and gait assessments.
- Undergo scheduled intervention sessions consisting of tDCS administration combined with video-based Action Observation Therapy.
- Attend follow-up assessment sessions at the end of the intervention period and 6 weeks post-intervention.
- Conditions
- Diplegic Cerebral Palsy
- Being tested
- Action Observation Therapy, Transcranial Direct Current Stimulation, Sham TDCs
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Action Observation TherapyOther
Observation of video recorded
Transcranial Direct Current StimulationDevice
Active Anodal tDCS (1-1.5 mA)
Sham TDCsDevice
Sham TDCs
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Active comparator | TDCS+ Action observation Therapy Receives: Other: Action Observation Therapy; Device: Transcranial Direct Current Stimulation |
| Control Group | Sham comparator | Sham TDCs + Action Observation Therapy Receives: Other: Action Observation Therapy; Device: Sham TDCs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gross Motor Functional Measurement (GMFM-88)
Assessment of Gross Motor Capacity focusing on standing
Measured: Baseline and 6 months (post - intervention)
Secondary outcomes (2)
10-Meter Walk Test (10MWT)
Measures walking speed in meters per second over 10 meters
Measured: Baseline and 6 weeks (post-intervention)
Modified Ashworth Scale (MAS) - Muscle tone
Evaluate muscle spasticity in lower limb joints
Measured: Baseline and 6 weeks (post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study start1 Jul 2026
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Diplegic Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ayesha Bashir, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07921095
- Sponsor's protocol ID
- RCRAHS-ISB/REC/MS-PT/02470
- Acronym
- tDCS
- Status last verified
- Nov 2026
- First submitted
- 2 Nov 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Magdy E, Hanna S, Shoukry KE-S. Effect of Action Observation Training on Gross Motor Functions in Children with Spastic Cerebral Palsy. Egyptian Journal of Hospital Medicine. 2025;97(1):3820-6.
Zhong M, Zhang Y, Luo J, Chen T, Zhang J, Peng T Sr, Han M, Le W, Peng T Jr, Xu K. Safety and effectiveness of non-invasive brain stimulation on mobility and balance function in children with cerebral palsy: a systematic review and meta-analysis. J Neuroeng Rehabil. 2025 May 18;22(1):111. doi: 10.1186/s12984-025-01619-7.
PubMed 40383797Lench DH, Christopher P, Gavioli M, Nytes G, Ikonomidou C, Villegas MA, Gillick BT. Long-term outcome safety assessment after teleneuromodulation in children with cerebral palsy. Brain Stimul. 2024 May-Jun;17(3):633-635. doi: 10.1016/j.brs.2024.04.017. Epub 2024 May 11. No abstract available.
PubMed 38740181Stein A, Riddle J, Caulfield KA, Dux PE, Friehs MA, Schroeder PA, Craven MP, Groom MJ, Iyer KK, Barlow KM. Safety, Feasibility, and Tolerability of Ten Days of At-Home, Remotely Supervised tDCS During Gamified Attention Training in Children with Acquired Brain Injury: An Open-Label, Dose-Controlled Pilot Trial. Brain Sci. 2025 May 24;15(6):561. doi: 10.3390/brainsci15060561.
PubMed 40563733Farzamfar P, Heirani A, Amiri E, Sedighi M, da Silva Machado DG. The Effect of Transcranial Direct Current Stimulation on M1 with and without Mirror Visual Feedback on Range of Motion and Hand Grip Strength of the Affected Upper Limb in Children with Spastic Hemiplegic Cerebral Palsy. Iran J Child Neurol. 2024 Fall;18(4):93-106. doi: 10.22037/IJCN.V18I4.45110. Epub 2024 Sep 29.
PubMed 39478944Tang L, Wu Y, Ma J, Lu Y, Wang L, Shan C. Application of tDCS in children with cerebral palsy: A mini review. Front Pediatr. 2022 Sep 20;10:966650. doi: 10.3389/fped.2022.966650. eCollection 2022.
PubMed 36204667Christopher P, Sutter EN, Gavioli M, Lench DH, Nytes G, Mak V, Simpson EA, Ikonomidou C, Villegas MA, Saiote C, Gillick BT. Safety, tolerability and feasibility of remotely-instructed home-based transcranial direct current stimulation in children with cerebral palsy. Brain Stimul. 2023 Sep-Oct;16(5):1325-1327. doi: 10.1016/j.brs.2023.08.024. Epub 2023 Aug 29. No abstract available.
PubMed 37652136He W, Huang Y, He L, Liu L, Zeng P, Qiu H, Wang X, Zhou H, Chen Z, Xu Y, Zhao J, Wang W, Tang H, Xu K. Safety and effects of transcranial direct current stimulation on hand function in preschool children with hemiplegic cerebral palsy: A pilot study. Front Behav Neurosci. 2022 Sep 9;16:925122. doi: 10.3389/fnbeh.2022.925122. eCollection 2022.
PubMed 36160682Beani E, Menici V, Sicola E, Ferrari A, Feys H, Klingels K, Mailleux L, Boyd R, Cioni G, Sgandurra G. Effectiveness of the home-based training program Tele-UPCAT (Tele-monitored UPper Limb Children Action Observation Training) in unilateral cerebral palsy: a randomized controlled trial. Eur J Phys Rehabil Med. 2023 Oct;59(5):554-563. doi: 10.23736/S1973-9087.23.07945-5. Epub 2023 Jul 18.
PubMed 37462399Jeong YA, Lee BH. Effect of Action Observation Training on Spasticity, Gross Motor Function, and Balance in Children with Diplegia Cerebral Palsy. Children (Basel). 2020 Jun 18;7(6):64. doi: 10.3390/children7060064.
PubMed 32570855Errante A, Beccani L, Verzelloni J, Maggi I, Filippi M, Bressi B, Ziccarelli S, Bozzetti F, Costi S, Ferrari A, Fogassi L. Effectiveness of action observation treatment based on pathological model in hemiplegic children: a randomized-controlled trial. Eur J Phys Rehabil Med. 2024 Aug;60(4):643-655. doi: 10.23736/S1973-9087.24.08413-2. Epub 2024 May 30.
PubMed 38814197Simon-Martinez C, Mailleux L, Jaspers E, Ortibus E, Desloovere K, Klingels K, Feys H. Effects of combining constraint-induced movement therapy and action-observation training on upper limb kinematics in children with unilateral cerebral palsy: a randomized controlled trial. Sci Rep. 2020 Jun 26;10(1):10421. doi: 10.1038/s41598-020-67427-2.
PubMed 32591590Beani E, Matteucci E, Sicola E, Martini G, Di Lieto MC, Bombonato C, Menici V, Cotardo A, Rizzo M, Filogna S, Camuncoli F, Biagi L, Cioni G, Fedeli F, Gelmini C, Neviani R, Vecchi O, Perazza S, Faccioli S, Errante A, Piras A, Sicuri E, Bozzetti F, Boyd RN, Ferrari A, Fogassi L, Sgandurra G. ACT-ON-DIP: Study Protocol of a Randomized Controlled Trial of a Home-Based ACTion Observation Tele-RehabilitatioN for Upper Limb in Children with DIPlegic Cerebral Palsy. Children (Basel). 2025 Sep 14;12(9):1229. doi: 10.3390/children12091229.
PubMed 41007094
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Additional Effects on Transcranial Direct Current Stimulation (tDCS) With Action Observation Therapy on Lower Limb Functions on Children With Diplegic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT07921095
- Acronym / sponsor ID
- tDCS / RCRAHS-ISB/REC/MS-PT/02470
- Conditions
- Diplegic Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 6 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does combining tDCS with AOT yield significantly greater improvements in gross motor function (measured by GMFM-88) compared to AOT alone?
- 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:
- Complete baseline clinical evaluations including gross motor, spasticity, and gait assessments.
- Undergo scheduled intervention sessions consisting of tDCS administration combined with video-based Action Observation Therapy.
- Attend follow-up assessment sessions at the end of the intervention period and 6 weeks post-intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Active comparator | Other: Action Observation Therapy, Device: Transcranial Direct Current StimulationTDCS+ Action observation Therapy |
| Control Group | Sham comparator | Other: Action Observation Therapy, Device: Sham TDCsSham TDCs + Action Observation Therapy |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Participants diagnosed with spastic diplegic cerebral palsy with a Modified Ashworth Scale (MAS) score of 2
- Age between 6 to 12 years old
- Participants classified as Communication Function Classification System (CFCS) Level II
- Participant with CFCS Level II
Key exclusion criteria (10 listed)
- Presence of uncontrolled epilepsy (any seizure within the past 6 months).
- Implanted metallic or electronic devices (e.g., pacemaker, cochlear implant, deep brain stimulator).
- Severe dystonia, ataxia, or predominant weakness interfering with upper limb or lower limb function.
- Severe visual impairment (not correctable with aids) preventing participation in action observation tasks.
- Botulinum toxin injections in the affected limb(s) within the past 6 months or planned during study period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Action Observation TherapyObservation of video recorded | Other | Control Group, Experimental Group |
| Transcranial Direct Current StimulationActive Anodal tDCS (1-1.5 mA) | Device | Experimental Group |
| Sham TDCsSham TDCs | Device | Control Group |
Primary outcome
Gross Motor Functional Measurement (GMFM-88)
Time frame: Baseline and 6 months (post - intervention)
Assessment of Gross Motor Capacity focusing on standing
2 secondary outcomes
10-Meter Walk Test (10MWT)
Time frame: Baseline and 6 weeks (post-intervention)
Modified Ashworth Scale (MAS) - Muscle tone
Time frame: Baseline and 6 weeks (post-intervention)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- BackgroundMagdy E, Hanna S, Shoukry KE-S. Effect of Action Observation Training on Gross Motor Functions in Children with Spastic Cerebral Palsy. Egyptian Journal of Hospital Medicine. 2025;97(1):3820-6.
- Background: PubMed 40383797Zhong M, Zhang Y, Luo J, Chen T, Zhang J, Peng T Sr, Han M, Le W, Peng T Jr, Xu K. Safety and effectiveness of non-invasive brain stimulation on mobility and balance function in children with cerebral palsy: a systematic review and meta-analysis. J Neuroeng Rehabil. 2025 May 18;22(1):111. doi: 10.1186/s12984-025-01619-7.
- Background: PubMed 38740181Lench DH, Christopher P, Gavioli M, Nytes G, Ikonomidou C, Villegas MA, Gillick BT. Long-term outcome safety assessment after teleneuromodulation in children with cerebral palsy. Brain Stimul. 2024 May-Jun;17(3):633-635. doi: 10.1016/j.brs.2024.04.017. Epub 2024 May 11. No abstract available.
- Background: PubMed 40563733Stein A, Riddle J, Caulfield KA, Dux PE, Friehs MA, Schroeder PA, Craven MP, Groom MJ, Iyer KK, Barlow KM. Safety, Feasibility, and Tolerability of Ten Days of At-Home, Remotely Supervised tDCS During Gamified Attention Training in Children with Acquired Brain Injury: An Open-Label, Dose-Controlled Pilot Trial. Brain Sci. 2025 May 24;15(6):561. doi: 10.3390/brainsci15060561.
- Background: PubMed 39478944Farzamfar P, Heirani A, Amiri E, Sedighi M, da Silva Machado DG. The Effect of Transcranial Direct Current Stimulation on M1 with and without Mirror Visual Feedback on Range of Motion and Hand Grip Strength of the Affected Upper Limb in Children with Spastic Hemiplegic Cerebral Palsy. Iran J Child Neurol. 2024 Fall;18(4):93-106. doi: 10.22037/IJCN.V18I4.45110. Epub 2024 Sep 29.
- Background: PubMed 36204667Tang L, Wu Y, Ma J, Lu Y, Wang L, Shan C. Application of tDCS in children with cerebral palsy: A mini review. Front Pediatr. 2022 Sep 20;10:966650. doi: 10.3389/fped.2022.966650. eCollection 2022.
- Background: PubMed 37652136Christopher P, Sutter EN, Gavioli M, Lench DH, Nytes G, Mak V, Simpson EA, Ikonomidou C, Villegas MA, Saiote C, Gillick BT. Safety, tolerability and feasibility of remotely-instructed home-based transcranial direct current stimulation in children with cerebral palsy. Brain Stimul. 2023 Sep-Oct;16(5):1325-1327. doi: 10.1016/j.brs.2023.08.024. Epub 2023 Aug 29. No abstract available.
- Background: PubMed 36160682He W, Huang Y, He L, Liu L, Zeng P, Qiu H, Wang X, Zhou H, Chen Z, Xu Y, Zhao J, Wang W, Tang H, Xu K. Safety and effects of transcranial direct current stimulation on hand function in preschool children with hemiplegic cerebral palsy: A pilot study. Front Behav Neurosci. 2022 Sep 9;16:925122. doi: 10.3389/fnbeh.2022.925122. eCollection 2022.
- Background: PubMed 37462399Beani E, Menici V, Sicola E, Ferrari A, Feys H, Klingels K, Mailleux L, Boyd R, Cioni G, Sgandurra G. Effectiveness of the home-based training program Tele-UPCAT (Tele-monitored UPper Limb Children Action Observation Training) in unilateral cerebral palsy: a randomized controlled trial. Eur J Phys Rehabil Med. 2023 Oct;59(5):554-563. doi: 10.23736/S1973-9087.23.07945-5. Epub 2023 Jul 18.
- Background: PubMed 32570855Jeong YA, Lee BH. Effect of Action Observation Training on Spasticity, Gross Motor Function, and Balance in Children with Diplegia Cerebral Palsy. Children (Basel). 2020 Jun 18;7(6):64. doi: 10.3390/children7060064.
- Background: PubMed 38814197Errante A, Beccani L, Verzelloni J, Maggi I, Filippi M, Bressi B, Ziccarelli S, Bozzetti F, Costi S, Ferrari A, Fogassi L. Effectiveness of action observation treatment based on pathological model in hemiplegic children: a randomized-controlled trial. Eur J Phys Rehabil Med. 2024 Aug;60(4):643-655. doi: 10.23736/S1973-9087.24.08413-2. Epub 2024 May 30.
- Background: PubMed 32591590Simon-Martinez C, Mailleux L, Jaspers E, Ortibus E, Desloovere K, Klingels K, Feys H. Effects of combining constraint-induced movement therapy and action-observation training on upper limb kinematics in children with unilateral cerebral palsy: a randomized controlled trial. Sci Rep. 2020 Jun 26;10(1):10421. doi: 10.1038/s41598-020-67427-2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ayesha Bashir contact
Ayesha Bashir principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Action Observation Therapy and Transcranial Direct Current Stimulation in people with Diplegic Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Ayesha Bashir, MS-NMPT (+923335256920, ayesha.bashir@riphah.edu.pk/), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gross Motor Functional Measurement (GMFM-88) (time frame: Baseline and 6 months (post - intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07921095, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.