Using Neurotechology to Help Children With Physical Disability Due to Cerebral Palsy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-17
SponsorUniversity of Alberta

About this trial

Hemiparetic cerebral palsy is a condition in which one side of a child's body becomes weak due to brain injury occurring around birth, often caused by stroke. Weakness on the affected side reduces the ability to use the involved hand and arm, limiting everyday activities such as dressing, eating, and playing. Few effective treatments currently exist, especially for children with severe weakness.

The study described here examines a new therapy that combines Brain-Computer Interface (BCI) technology with Functional Electrical Stimulation (FES). BCI technology uses brain signals to control external devices; in this therapy, brain signals activate muscles through electrical stimulation. When a child imagines wrist movement, the system detects the associated brain activity and delivers electrical stimulation to generate actual movement. Such paired activity supports neural rewiring and strengthens connections between the brain and muscles, leading to improved arm function.

Previous research demonstrates strong benefits of BCI-FES for adults after stroke, but minimal testing has been conducted with children. The current study will evaluate whether BCI-FES improves arm and hand function in children aged 12 to 17 with hemiparetic cerebral palsy.

Participants will complete 15 to 20 sessions over a two-month period while wearing a cap that records brain signals. During each session, the system provides muscle stimulation and visual feedback through animated hand movements. Outcome measures will include performance of daily tasks, hand dexterity, muscle activity, and the presence of any adverse effects.

The overarching goal is to create a fun, engaging, and effective therapy that supports recovery of hand use and greater independence. Successful results could guide larger studies and inspire new technology-based treatments that enhance quality of life for children with cerebral palsy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Clinically confirmed and functionally disabling moderate to severe hemiparetic CP (GMFCS levels I-IV and MACS levels II&III) with personalized goals that include improvement of wrist extension of affected upper extremity

Age 12-17 years,

Informed Consent/assent,

Normal corrected vision and hearing

Disqualifiers

Bilateral perinatal stroke

Motor strength of wrist extension zero

Severe hemiparesis (MACS V)

Severe developmental delay and/or other inability to comply with study protocol

Trial design

Design model

Single group

Treatments tested in this trial

  • Brain Computer Interface - Functional Electrical Stimulations

    Device

    This intervention combines EEG-based brain-computer interface (BCI) technology with functional electrical stimulation (FES), allowing participants to control muscle activation using their brain signals. Unlike traditional FES or passive rehabilitation methods, this approach actively engages the user's intent, potentially enhancing neuroplasticity and motor recovery.

Treatment groups

8 Participants
are divided into 1 treatment group
Group A: ParticipantsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Melbourne Assessment 2

It is a standardized tool used to assess the quality of upper limb movement in children aged 2.5 to 15 years with neurological conditions such as cerebral palsy. It evaluates components like range of motion, accuracy, fluency, and dexterity through functional tasks.

Time frame
Baseline and immediately after the intervention
2

Safety and Tolerability Measure

Safety and tolerability assessment questionnaire will be completed following every session capturing and scaling predefined and any other potential side effects.

Time frame
Baseline and immediately after the intervention

Secondary outcomes

1

The ReJoyce Automated Hand Function Test (RAHFT)

It is a quick, easy, and standardised assessment tool which assesses a participants's range of motion, hand control, speed, and ¬finger dexterity through a variety of ADLs.

Time frame
Baseline and immediately after the intervention
2

Box and Block Test (BBT)

The BBT is an easy-to-administer, valid and reliable assessment of gross manual dexterity

Time frame
Baseline and immediately after the intervention
3

Stanford Expectations Scale (SETS)

It will be administered at baseline to assess participants' and parents' pre-treatment expectations.

Time frame
Baseline and immediately after the intervention

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Alberta

Lead sponsor

Alberta Health services

Collaborator