ClinicalTrials.gg
RecruitingNCT06730763Updated Feb 11, 2025

Effect of Transcranial Direct Current Stimulation on Risk of Falling in Cerebral Palsy Spastic Hemiplegic Children

An interventional study of Transcranial direct current stimulation and Exercise in Cerebral Palsy (CP), sponsored by Cairo University. Recruiting at 1 site in Egypt. Open to participants aged 8 Years to 12 Years. Per ClinicalTrials.gov, last updated 2025-02-11.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Feb 2025, 1 year 9 months ago, but the record still lists the study as recruiting.
  • Started Dec 2024; still recruiting 1 year 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
8 Years to 12 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 114 studies in Cerebral Palsy by Cairo University — 28 open to participants now, 34 under way, 1 of them phase 3. Cerebral Palsy · Cairo University.

Planned enrollment
68th of 94
30 · median 40
Started
2024
with 11 others
No phase
93 of 114
23 open now
Primary completion
2025-02
later than 6 of 33 live
Registered
67th of 114
by date

Among the 114 studies in Cerebral Palsy by Cairo University, this one is the 68th largest by planned enrollment of the 94 interventional ones that give a count, is one of 12 that started in 2024, is one of 93 with no phase, reaches primary completion later than 6 of the 33 other live ones, and was the 67th registered.

Cerebral Palsy

1,936 studies on the registry are indexed under Cerebral Palsy; 458 are open to participants now.

Browse Cerebral Palsy studies →

Open to participants now

28 of the 114 studies in Cerebral Palsy by Cairo University are open now, in 1 country. Recruiting first, the newest first:

22 more — sign in →

By country, each count listing its studies:

All 28 open studies →

Where they have run

Who these studies take

Of the 270 Cerebral Palsy studies recruiting now, 27 (10%) set no upper age limit and 235 (87%) stop at 75 or younger; 255 take children under 18; 51 take healthy volunteers.

This study: 8 Years to 12 Years · all sexes · no healthy volunteers.

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02

Study summary

The purpose of this study was to determine:

  • If there is an effect of transcranial direct current stimulation in improvement the functional balance in CP spastic hemiplegic children.
  • If there are any changes in risk of falling in CP spastic hemiplegic children or not.
Read the detailed description

With the decline of mobility comes a drastic increase in falling. However, people of all ages with cerebral palsy can fall easily due to imbalance issues and non-voluntary movements. Individuals with cerebral palsy (CP) can experience a variety of sensorimotor impairments that impact balance, making excessive tripping and falling among the most common concerns for ambulatory individuals with CP. Approximately 53-97% of ambulatory individuals fall at least once per year, causing injury, embarrassment, frustration, activity avoidance, and isolation. Although a study of over 1000 children found fall frequency was highest in gross motor function classification system (GMFCS) level II, research has not explored if this holds across the decades of adulthood.

03

Conditions studied

  • Cerebral Palsy (CP)

Keywords

  • cerebral palsy
  • spastic hemiplegia
  • risk of falling
04

Who can participate

Ages eligible
8 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age range between 8-12 years old.
  • Classified on levels II and III of the Gross Motor Function Classification System (GMFCS) (Palisiano et al.,1997).
  • the ability to walk without the assistance of another individual for at least 12 months prior to the onset of the study, regardless of whether a gait-assistance device was needed (GMFCS level III) or not (GMFCS level II).
  • (Pediatric Balance Scale, Timed Up and Go Test 'TUGT') and acceptance of the TDCS procedure.
  • Ability to understand and follow simple instructions.
  • Parent or guardian consent obtained

Exclusion criteria

Exclusion Criteria:

  • Orthopedic deformities, a history of surgery or neurolytic block in the previous 12 months,
  • Diagnosis of epilepsy or having experienced convulsive crises (whether treated with medication or not) in at least the two years prior to the onset of the study, metal implants in the skull, or the use of hearing aids.
  • Previous participation in a tDCS study within the past 6 months.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Group 1

    will receive selected traditional physical therapy program for improve balance and decrease risk of falling only.

    Device: Transcranial direct current stimulation · Other: Exercise

  • Active comparator
    Group 2

    will receive transcranial direct current stimulation plus selected traditional physical therapy program.

    Other: Exercise

Interventions

  • DeviceTranscranial direct current stimulation

    Transcranial direct current stimulation (TDCS) is a non-invasive, painless brain stimulation treatment that uses direct electrical currents to stimulate specific parts of the brain.

    Also known as: transcranial, TcDc

  • OtherExercise

    selected traditional physical therapy program for improve balance and decrease risk of falling

    Also known as: traditional

06

What researchers measure

Primary outcomes

  1. The Fall Risk test

    The fall risk test allowed identification of potential fall candidates. Test results were compared to age dependent normative data. Scores higher than normative values suggested more fall risk index

    Time frame: From enrollment to the end of treatment at 8 weeks

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2024 (actual). Primary completion is estimated for Feb 2025, 2 months after the start.

Of 902 non-industry interventional studies with no phase under Cerebral Palsy, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 31. This study's planned 2 months is below that.

Counting every sponsor, half of 921 studies reached it within 12 months; a quarter within 5 and three quarters within 31.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 9, 2024
First posted
Dec 12, 2024
StartActual
Dec 1, 2024
Primary completionEst.
Feb 1, 2025
CompletionEst.
Jun 1, 2025
Last update
Feb 11, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06730763
Lead sponsor
Cairo University
Responsible party
Dr. Ahmed Fathy Mahmoud Awd (Physiotherapist, Cairo University) — Principal investigator
First posted
Dec 12, 2024
Start date
Dec 1, 2024
Primary completion
Feb 1, 2025 (estimated)
Completion
Jun 1, 2025 (estimated)
Last update
Feb 11, 2025

Study contacts

Ahmed fathy Awad, Master degree
Contact
ahmedawdpt@gmail.com
00201061263992

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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