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Cerebral Palsy (CP)NCT07342660

Transcranial Direct Current Stimulation and Treadmill in Cerebral Palsy

A study testing transcranial direct current stimulation in people with Cerebral Palsy (CP), run by University of Sharjah at 1 site in United Arab Emirates.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Background: Cerebral Palsy (CP) is characterized by altered excitability in bilateral sensorimotor cortical areas. Previous research using unilateral anodal transcranial direct current stimulation (tDCS) has yielded inconsistent results, highlighting a need for alternative stimulation approaches. Read more about this study

Who is it for?
Ages 4 to 12 years
Conditions the study is for
Cerebral Palsy (CP)
What is being tested?
transcranial direct current stimulation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
1 siteUnited Arab Emirates
Study dates
1 Jul 2020to 1 Jul 2025
Phase
Interventional
Are there results?
None posted in the registry

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 4 to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Gross Motor Function Classification System (GMFCS) level of I-III
  • ability to walk independently for at least 10 meters
  • IQ greater than 70

Who cannot join

  • history of orthopedic surgery
  • history of neurolytic blocks,
  • history of Botox injections in the past six months
  • Presence of concurrent orthopedic impairments
  • Presence of epilepsy
  • Presence of intracranial metal implants

Trial locations and contacts

1 site in 1 country.

United Arab Emirates1 site
  • University of Sharjah

    Sharjah city, Emirate of Sharjah, 27272

Other trials in United Arab Emirates

About this study

Official title: The Therapeutic Effect of Transcranial Direct Current Stimulation and Treadmill in Children With Cerebral Palsy

Background: Cerebral Palsy (CP) is characterized by altered excitability in bilateral sensorimotor cortical areas. Previous research using unilateral anodal transcranial direct current stimulation (tDCS) has yielded inconsistent results, highlighting a need for alternative stimulation approaches.

Objective: This study evaluated the feasibility, safety, and preliminary efficacy of combining bilateral anodal transcranial direct current stimulation (tDCS) over the sensorimotor cortices with treadmill training in children with CP.

Read more

Methods: A within-subjects case series was conducted with five children with CP. Participants received ten sessions of treadmill training (at 50% of their maximum over-ground speed) concurrently with bilateral anodal tDCS. Outcomes, assessed pre- and post-intervention, included postural alignment (medio-lateral and anterior-posterior), ankle dorsiflexion range of motion, gait variability, walking tolerance (6-minute walk test), motor function (GMFM-66), and hip/knee range of motion. Statistical analysis was performed using paired t-tests and effect sizes (Hedges' g).

Anticipated Impact: This study will pioneer a novel bilateral tDCS montage for CP rehabilitation. The findings are expected to provide critical insights into the synergistic relationship between neuromodulation and physical training, ultimately informing more effective, evidence-based interventions to enhance motor function and participation in this population.

Read the detailed description

Introduction Motor control and coordination in pediatric cerebral palsy patients have been improved through various methods. Treadmill training demonstrates efficacy in enhancing gait velocity, balance, and functional independence. Furthermore, transcranial direct current stimulation (tDCS) presents a non-invasive and safe alternative to surgical or pharmacological treatments. Collectively, these interventions have proven effective in advancing gait performance and functional capabilities in this population.

The optimal protocol for administering tDCS to pediatric cerebral palsy patients has yet to be established. Contrary to earlier studies that utilized unilateral anodal stimulation targeting the contralateral motor cortex, a hypothesis suggests that bilateral stimulation of both hemispheres could yield superior outcomes. This premise is supported by magnetoencephalography (MEG) a widespread disruption in neural excitability within both sensory-motor cortices of children with CP. This bilateral impairment occurs even in cases of unilateral lesions and contributes to reduced activation in corticospinal pathways. Accordingly, subsequent research applying unilateral anodal tDCS to the ipsilateral motor cortex (non-lesioned hemisphere) demonstrated enhancements in motor functions such as reaching skills and movement duration.

As a feasibility study, this pilot research assessed the practicality and initial effects of administering bilateral anodal tDCS concurrently with treadmill training to enhance gait parameters, range of motion, and reduce spasticity in pediatric patients with diplegic CP.

Methods Study design \& participants This clinical study was approved by the IRB committee of Jordan University of Science and Technology and the King Abdullah University Hospital (#2019/420) based on the Declaration of Helsinki. Five children (aged 4-12 years) with spastic diplegic CP were enrolled. Inclusion criteria stipulated a Gross Motor Function Classification System (GMFCS) level of I-III, the ability to walk independently for at least 10 meters, and an IQ greater than 70. Key exclusion criteria included a history of orthopedic surgery, neurolytic blocks, or Botox injections in the past six months, as well as the presence of concurrent orthopedic impairments, epilepsy, intracranial metal implants, or hearing aids. In addition, voluntary written informed consent was obtained from all participant children by their legal guardians before participation in the study.

Treadmill training \& tDCS intervention While prior research utilizing unilateral anodal tDCS in children with CP positioned a single anode over the C3 or C4 motor cortex and a cathode on the supra-orbital area according to the 10-20 EEG system, the present study employed a bilateral montage. Using the 10-10 EEG system for more precise placement, two anodes were positioned over the left FC1 and right FC2 regions (encompassing motor and frontal areas), with two corresponding cathodes located over the bilateral supra-orbital areas. A low current intensity of 1mA was applied.

The therapeutic protocol commenced with two treadmill familiarization sessions. This was followed by ten combined treatment sessions, each consisting of a 12-minute interval: a 1-minute warm-up, a 10-minute simultaneous treadmill training and tDCS therapy period, and a 1-minute cool-down. Treadmill speed was initiated at 50% of the child's maximum ground speed from the 6-Minute Walk Test (6MWT) and was progressively increased based on individual tolerance. Tolerance was gauged by the absence of fatigue complaints, a heart rate not exceeding 70% of maximum, and the maintenance of proper gait without shuffling. Assistants were present to provide support and verbal feedback to promote correct movement patterns.

Outcome Measures

Outcome Measures Pre- and post-intervention data were collected, including:

  1. Postural alignment (medio-lateral displacement)
  2. Postural alignment (anterior-posterior displacement)
  3. Ankle dorsiflexion range of motion (degrees)
  4. Hip range of motion (degrees)
  5. Knee range of motion (degrees)
  6. Walking endurance assessed using the 6-Minute Walk Test (distance in meters)
  7. Gross motor function assessed using the GMFM-66 (total score)
  8. Gait speed (meters/second)
  9. Gait variability (dimensionless autocorrelation coefficient)

Data analysis Due to the cautions reported in the previous study of using the paired t-test with extremely small sample sizes (n = 5), the mean ± standard deviation was calculated for all outcome measures, the intervention's clinical effect size was determined using Hedges' g, with values indicating small, moderate, or large effects, and gait outcomes were measured by having each child walk a 10 m track twice before and after the intervention. Data is available.

  1. Result and Discussion This study protocol is innovative in term of the tDCS stimulation protocol (bilateral anodal tDCS vs. unilateral anodal tDCS), and its outcome measures that include evaluation of the brain activity and plasticity, quantitative gait outcome measures (kinematics and kinetics), motor development, quality of life, and level of enjoyment and participation, which were not examined in one full set previously.

In addition, bilateral anodal tDCS would be feasible, and safe rehabilitation tools that would modulate the brain activity and improve the gait function, balance functions, endurance, quality of life, and level of participation and enjoyment of children with CP. Therefore, exploring such short and long-term therapeutic effects of the bilateral anodal tDCS on the children's body functions, activity and participation outcome measures provide us a promising non-invasive tool in CP rehabilitation that would be combined with many other rehabilitation tools and approaches such as behavioral therapy, virtual reality, thera suit, and many other that all used as CP rehabilitation and others neurological condition. In addition, exploring the relationship between brain activity modulation, gait functions changes, and motor development and level of participation and enjoyment would provide a better understanding of this interconnected matrix that we have to consider in our future rehabilitation approaches and strategies of children with CP, and thus serve as an important aspect that will contribute to evidence-based practice in pediatric rehabilitation Besides, it would provide us a better understanding of the mechanism behind the tDCS effects.

Keywords
Cerebral palsy, transcranial direct current stimulation, treadmill, gait function, balance
Medical subject headings
Cerebral Palsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • transcranial direct current stimulationOther

    Also called treadmill

    The therapeutic protocol commenced with two treadmill familiarization sessions. This was followed by ten combined treatment sessions, each consisting of a 12-minute interval: a 1-minute warm-up, a 10-minute simultaneous treadmill training and tDCS therapy period, and a 1-minute cool-down. Treadmill speed was initiated at 50% of the child's maximum ground speed from the 6-Minute Walk Test (6MWT) and was progressively increased based on individual tolerance.

Study groups in NCT07342660
Study groupRoleWhat they receive
tDCS & TreadmillExperimentalThe therapeutic protocol commenced with two treadmill familiarization sessions. This was followed by ten combined treatment sessions.
Receives: Other: transcranial direct current stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Gait speed

    Gait speed (meters/second)

    Measured: Baseline (within 7 days prior to the first intervention session) Immediately post-intervention (within 7 days following completion of the 10-session intervention period; up to 4 weeks from baseline)

  2. Gait variability

    Gait variability (dimensionless autocorrelation coefficient)

    Measured: Baseline (within 7 days prior to the first intervention session) Immediately post-intervention (within 7 days following completion of the 10-session intervention period; up to 4 weeks from baseline)

  3. Walking endurance

    Walking endurance assessed using the 6-Minute Walk Test (distance in meters walked within 6 minutes intervals)

    Measured: Baseline (within 7 days prior to the first intervention session) Immediately post-intervention (within 7 days following completion of the 10-session intervention period; up to 4 weeks from baseline)

  4. Developmental Motor function

    Gross motor function measure - Item set scale (Total Score, Higher score good motor function development, lower score poor motor function development)

    Measured: Baseline (within 7 days prior to the first intervention session) Immediately post-intervention (within 7 days following completion of the 10-session intervention period; up to 4 weeks from baseline)

  5. Postural Alignment

    Postural alignment (medio-lateral displacement in cm)

    Postural alignment (anterior-posterior displacement in cm)

    Measured: Baseline (within 7 days prior to the first intervention session) Immediately post-intervention (within 7 days following completion of the 10-session intervention period; up to 4 weeks from baseline)

Secondary outcomes (2)
  1. Spasticity

    Modified Ashworth scale (Total Score)

    Measured: Baseline (within 7 days prior to the first intervention session) Immediately post-intervention (within 7 days following completion of the 10-session intervention period; up to 4 weeks from baseline)

  2. Joint Range of Motion

    Ankle dorsiflexion range of motion (degrees)

    Hip range of motion (degrees)

    Knee range of motion (degrees)

    Measured: Baseline (within 7 days prior to the first intervention session) Immediately post-intervention (within 7 days following completion of the 10-session intervention period; up to 4 weeks from baseline)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jan 2026
  2. Study start1 Jul 2020
  3. Primary completion1 May 2025
  4. Study completion1 Jul 2025

Resources

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
Not applicable
Intervention model
Single group
Model description
Pilot study
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07342660
Sponsor's protocol ID
4202019
Other IDs
4322019
Status last verified
Jan 2026
First submitted
22 Nov 2025
Last updated
15 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data (IPD) collected during the study will be made available. This will include analyzable datasets underlying the reported outcomes, such as gait parameters, range of motion measures, walking endurance (6-Minute Walk Test), and Gross Motor Function Measure (GMFM-66) scores. No direct identifiers will be shared. Supporting documentation, including the study protocol and statistical analysis plan, may also be made available upon request.

Questions about this trial

What is this clinical trial studying?

A study testing transcranial direct current stimulation in people with Cerebral Palsy (CP), run by University of Sharjah at 1 site in United Arab Emirates.

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 3 inclusion and 6 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: finished, as of the sponsor's last update on 15 Jan 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 United Arab Emirates. 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gait speed (time frame: Baseline (within 7 days prior to the first intervention session) Immediately post-intervention (within 7 days following completion of the 10-session intervention period; up to 4 weeks from baseline)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 15 Jan 2026.

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