Brain stimulation with virtual reality for balance in children with spastic diplegic cerebral palsy

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children aged 8 to 16 with spastic diplegic cerebral palsy, a type of cerebral palsy with stiff legs. It tests mild brain stimulation (tDCS) with virtual reality training for balance and thinking skills.

Age

8 to 16 years

Sex

All sexes can join

Disease stage

Spastic diplegia. Gross Motor Function Classification System (GMFCS) levels I-III. Mild to moderate leg stiffness: Modified Tardieu Scale score between 1 and 3 in at least one major leg muscle group. The child must understand and follow spoken instructions.

Earlier treatment

No Botulinum toxin injection within the previous 3 months. No current antispasticity medication that could affect stiffness results. No recent orthopedic surgery or medication change within the previous 5 days.

Main reasons for not taking part

• History of seizures or epilepsy
• Implanted metal or electronic devices, such as a pacemaker
• Severe cognitive impairment that prevents understanding the study tasks
• Skin allergies, sores or other skin problems where the electrodes go
• Taking part in other therapies outside the study

The registry criteria, word for word

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

• Are you between 8 and 16 years old?YesNo

What the trial wants to find out

Children with spastic diplegic cerebral palsy commonly experience difficulties with balance and may also have challenges involving attention, working memory, cognitive flexibility, and inhibitory control. Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique that may influence motor-cortical excitability, while virtual reality (VR) rehabilitation provides repetitive, interactive, and task-oriented training.

The 3 groups in the trial

• Active tDCS + Virtual RealityTreatment being tested

  participants will receive active transcranial direct current stimulation at 1 mA for 20 minutes combined with virtual reality rehabilitation, three sessions per week for six weeks, for a total of 18 sessions.

  Treatment: Active Transcranial Direct Current Stimulation and Virtual Reality Rehabilitation

• Sham tDCS + Virtual RealitySham treatment, for comparison

  Participants will receive sham transcranial direct current stimulation using the same electrode setup as the active condition, with brief initial stimulation to mimic active tDCS, combined with the same virtual reality rehabilitation protocol, three sessions per week for six weeks, for a total of 18 sessions.

  Treatment: Sham Transcranial Direct Current Stimulation and Virtual Reality Rehabilitation

• Conventional Physical TherapyExisting treatment, for comparison

  Participants will receive conventional physical therapy including lower-limb stretching, strengthening, balance training, motor-control exercises, gait-related training, and functional mobility activities, three sessions per week for six weeks.