Hemiparetic Cerebral PalsyNCT07269353
Using Neurotechology to Help Children With Physical Disability Due to Cerebral Palsy
A study testing Brain Computer Interface - Functional Electrical Stimulations in people with Hemiparetic Cerebral Palsy, run by University of Alberta at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Hemiparetic Cerebral Palsy
- What is being tested?
- Brain Computer Interface - Functional Electrical Stimulations
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteCanada
- Study dates
- 5 Feb 2026to 1 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
- Ability to maintain supported sitting for 30 min or more
Who cannot join
- 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
- Severe wrist contractures limiting wrist extension
- Upper extremity orthopedic surgery or botulinum toxin in the preceding 6 months,
- Initial classification accuracy below level of significance (as determined by the BCI system)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Glenrose Rehabilitation Hospital
Edmonton, Alberta, T5G 0B7
Monica Gorassini, PhD, (780) 492-2463, mag4@ualberta.ca
About this study
Official title: Enhancing Pediatric Neurorehabilitation: Integration of Brain-Computer Interface (BCI) and Functional Electrical Stimulation (FES) Technologies to Improve Upper Extremity Function in Children With Cerebral Palsy
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.
Read more
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.
Read the detailed description
Purpose Hemiparetic cerebral palsy leads to severe unilateral motor weakness that impairs upper limb function and daily living in children. Effective, evidence-based therapies-particularly engaging, intensive interventions such as Brain-Computer Interface combined with Functional Electrical Stimulation (BCI-FES)-remain limited and underexplored in pediatric populations. The study aims to address this gap by adapting and validating a child-centered BCI-FES rehabilitation model for upper-extremity motor impairments, enabling effective and engaging therapy for children with hemiparetic cerebral palsy.
Objectives Aim 1: Determine the efficacy of BCI-activated FES for children with hemiparetic cerebral palsy in improving functional outcomes.
Aim 2: Develop, validate, and optimize a child-centered BCI-FES rehabilitation model that improves upper-extremity motor function and daily living activities in children with hemiparetic cerebral palsy, enabling scalable, effective neurotechnology-based therapies that enhance functional independence and quality of life within pediatric rehabilitation.
Method The setup combines EEG, FES, and real-time visual feedback to create a closed-loop training system. During each session, an EEG cap records motor-related brain activity while a participant imagines a specific movement (for example, wrist extension). When the system correctly identifies motor imagery, the system delivers FES to the corresponding muscles and displays the associated movement on a screen through an animated avatar.
The project uses the g.tec recoveriX system (g.tec, Schiedlberg, Austria), a commercially available BCI suite that integrates EEG recording and functional electrical stimulation.
BCI: EEG signals are recorded using a 16-channel, gel-based EEG headset. Recording electrodes are placed according to the international 10-10 system. The classification algorithm generates classification accuracy, defined as the percentage of correct predictions produced by the BCI when identifying intended motor-imagery commands.
FES: Electrical muscle stimulation is delivered bilaterally through two g.Estim electrical stimulators (g.tec, Graz, Austria), which generate rectangular biphasic constant-current pulses.
Visual Feedback: A monitor positioned directly in front of each participant displays two virtual hand avatars that provide real-time visual feedback mirroring intended movement. When the system successfully detects motor imagery, the avatar performs the corresponding movement on the screen.
Intervention The intervention consists of two components: Training Sessions and Rehabilitation Sessions.
Training Sessions: Training calibrates the system by recording EEG signals during motor imagery of left or right wrist extension. Participants are guided to visualize wrist extension for both hands. Each session includes three trials of approximately 15 minutes. Each trial contains 80 runs lasting 8 seconds.
Rehabilitation Sessions: During rehabilitation, the classifier generated during training drives visual and electrical feedback. Participants complete up to three trials per session, using audio cues to guide motor-imagery attempts. Visual feedback and electrical stimulation are provided only when motor imagery is accurately classified and matches the cue direction.
Participants attend 15 to 20 recoveriX sessions over three consecutive weeks. Each session lasts up to 90 minutes and includes randomized motor-imagery trials involving both limbs. Sessions are adjusted according to participant tolerance, with scheduled rest periods and optional additional breaks to maintain comfort and engagement.
- Conditions
- Hemiparetic Cerebral Palsy
- Being tested
- Brain Computer Interface - Functional Electrical Stimulations
- Keywords
- Cerebral Palsy, BCI, FES, BCI-FES, Rehabilitation, Pediatric, Children
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain Computer Interface - Functional Electrical StimulationsDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Participants | Experimental | Participant receiving 20 sessions of BCI + FES using recoveriX All Sessions = 90 Minutes During the first visit, participants will receive a detailed explanation of the study and undergo an eligibility screening conducted by an occupational therapist. Before the intervention start, at mid-point and after the intervention, several hand function assessments will be performed, including the Melbourne Assessment, Box and Blocks Test, and the ReJoyce Automated Hand Function Test (RAHFT). Participants will also complete a Safety and Tolerability Survey and the Stanford Survey. Investigators will then fit an EEG headset to record brain signals used to control Functional Electrical Stimulation (FES).
The intervention session will be take 90 mins and will include 60min of BCI-FES using a system called recoveriX. Receives: Device: Brain Computer Interface - Functional Electrical Stimulations |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and immediately after the intervention
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.
Measured: Baseline and immediately after the intervention
Secondary outcomes (3)
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.
Measured: Baseline and immediately after the intervention
Box and Block Test (BBT)
The BBT is an easy-to-administer, valid and reliable assessment of gross manual dexterity
Measured: Baseline and immediately after the intervention
Stanford Expectations Scale (SETS)
It will be administered at baseline to assess participants' and parents' pre-treatment expectations.
Measured: Baseline and immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study start5 Feb 2026
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemiparetic Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Alberta Health services
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07269353
- Sponsor's protocol ID
- Pro00156777
- Status last verified
- Feb 2026
- First submitted
- 16 Nov 2025
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Pediatric Neurorehabilitation: Integration of Brain-Computer Interface (BCI) and Functional Electrical Stimulation (FES) Technologies to Improve Upper Extremity Function in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT07269353
- Acronym / sponsor ID
- Pro00156777
- Conditions
- Hemiparetic Cerebral Palsy
- Keywords
- Cerebral Palsy, BCI, FES, BCI-FES, Rehabilitation, Pediatric, Children
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Alberta Health services
- Study start
- 5 Feb 2026 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 8 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Purpose Hemiparetic cerebral palsy leads to severe unilateral motor weakness that impairs upper limb function and daily living in children. Effective, evidence-based therapies-particularly engaging, intensive interventions such as Brain-Computer Interface combined with Functional Electrical Stimulation (BCI-FES)-remain limited and underexplored in pediatric populations. The study aims to address this gap by adapting and validating a child-centered BCI-FES rehabilitation model for upper-extremity motor impairments, enabling effective and engaging therapy for children with hemiparetic cerebral palsy.
Objectives Aim 1: Determine the efficacy of BCI-activated FES for children with hemiparetic cerebral palsy in improving functional outcomes.
Aim 2: Develop, validate, and optimize a child-centered BCI-FES rehabilitation model that improves upper-extremity motor function and daily living activities in children with hemiparetic cerebral palsy, enabling scalable, effective neurotechnology-based therapies that enhance functional independence and quality of life within pediatric rehabilitation.
Method The setup combines EEG, FES, and real-time visual feedback to create a closed-loop training system. During each session, an EEG cap records motor-related brain activity while a participant imagines a specific movement (for example, wrist extension). When the system correctly identifies motor imagery, the system delivers FES to the corresponding muscles and displays the associated movement on a screen through an animated avatar.
The project uses the g.tec recoveriX system (g.tec, Schiedlberg, Austria), a commercially available BCI suite that integrates EEG recording and functional electrical stimulation.
BCI: EEG signals are recorded using a 16-channel, gel-based EEG headset. Recording electrodes are placed according to the international 10-10 system. The classification algorithm generates classification accuracy, defined as the percentage of correct predictions produced by the BCI when identifying intended motor-imagery commands.
FES: Electrical muscle stimulation is delivered bilaterally through two g.Estim electrical stimulators (g.tec, Graz, Austria), which generate rectangular biphasic constant-current pulses.
Visual Feedback: A monitor positioned directly in front of each participant displays two virtual hand avatars that provide real-time visual feedback mirroring intended movement. When the system successfully detects motor imagery, the avatar performs the corresponding movement on the screen.
Intervention The intervention consists of two components: Training Sessions and Rehabilitation Sessions.
Training Sessions: Training calibrates the system by recording EEG signals during motor imagery of left or right wrist extension. Participants are guided to visualize wrist extension for both hands. Each session includes three trials of approximately 15 minutes. Each trial contains 80 runs lasting 8 seconds.
Rehabilitation Sessions: During rehabilitation, the classifier generated during training drives visual and electrical feedback. Participants complete up to three trials per session, using audio cues to guide motor-imagery attempts. Visual feedback and electrical stimulation are provided only when motor imagery is accurately classified and matches the cue direction.
Participants attend 15 to 20 recoveriX sessions over three consecutive weeks. Each session lasts up to 90 minutes and includes randomized motor-imagery trials involving both limbs. Sessions are adjusted according to participant tolerance, with scheduled rest periods and optional additional breaks to maintain comfort and engagement.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | Experimental | Device: Brain Computer Interface - Functional Electrical StimulationsParticipant receiving 20 sessions of BCI + FES using recoveriX All Sessions = 90 Minutes During the first visit, participants will receive a detailed explanation of the study and undergo an eligibility screening conducted by an occupational therapist. Before the intervention start, at mid-point and after the intervention, several hand function assessments will be performed, including the Melbourne Assessment, Box and Blocks Test, and the ReJoyce Automated Hand Function Test (RAHFT). Participants will also complete a Safety and Tolerability Survey and the Stanford Survey. Investigators will then fit an EEG headset to record brain signals used to control Functional Electrical Stimulation (FES). The intervention session will be take 90 mins and will include 60min of BCI-FES using a system called recoveriX. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
- Ability to maintain supported sitting for 30 min or more
Key exclusion criteria (7 listed)
- 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
- Severe wrist contractures limiting wrist extension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brain Computer Interface - Functional Electrical StimulationsThis 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. | Device | Participants |
Primary outcome
Melbourne Assessment 2
Time frame: Baseline and immediately after the intervention
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.
Safety and Tolerability Measure
Time frame: Baseline and immediately after the intervention
Safety and tolerability assessment questionnaire will be completed following every session capturing and scaling predefined and any other potential side effects.
3 secondary outcomes
The ReJoyce Automated Hand Function Test (RAHFT)
Time frame: Baseline and immediately after the intervention
Box and Block Test (BBT)
Time frame: Baseline and immediately after the intervention
Stanford Expectations Scale (SETS)
Time frame: Baseline and immediately after the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brain Computer Interface - Functional Electrical Stimulations in people with Hemiparetic Cerebral Palsy, run by University of Alberta at 1 site in Canada.
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 5 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 9 Feb 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 Canada. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ephrem Zewdie, MD, PhD ((780) 492-2463, etakele@ualberta.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Melbourne Assessment 2 (time frame: Baseline and immediately after the intervention). The study lists 2 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 9 Feb 2026.