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

February 10, 2025 updated by: Dr. Ahmed Fathy Mahmoud Awd, Cairo University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

30

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 Locations

  • Egypt
      • Giza, Egypt, 3753450
        • Recruiting
        • Cairo University
        • Contact:

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

  • Child

Accepts Healthy Volunteers

No

Description

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:

  • 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.

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1
will receive selected traditional physical therapy program for improve balance and decrease risk of falling only.
Device: Transcranial 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.
Other Names:
  • transcranial
  • TcDc
Other: Exercise
selected traditional physical therapy program for improve balance and decrease risk of falling
Other Names:
  • traditional
Active Comparator: Group 2
will receive transcranial direct current stimulation plus selected traditional physical therapy program.
Other: Exercise
selected traditional physical therapy program for improve balance and decrease risk of falling
Other Names:
  • traditional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Fall Risk test
Time Frame: From enrollment to the end of treatment at 8 weeks
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
From enrollment to the end of treatment at 8 weeks

Collaborators and Investigators

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

Sponsor

Cairo University

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)

December 1, 2024

Primary Completion (Estimated)

February 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

December 9, 2024

First Submitted That Met QC Criteria

December 9, 2024

First Posted (Actual)

December 12, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 10, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P.T.REC.012/005208

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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