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StrokeNCT07807176

Neuromodulation Combined With Dual FES Cycling and Cognitive Training After Stroke

A study testing Functional Electrical Stimulation Cycling, Cognitive Task Training and Transcutaneous Auricular Photobiomodulation in people with Stroke, run by Chang Gung Memorial Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This study will evaluate the effects of functional electrical stimulation (FES) cycling, cognitive task training, and non-invasive photobiomodulation on cognitive and upper-limb motor performance in adults after stroke. Read more about this study

Who is it for?
Ages 20 to 80 years
Conditions the study is for
Stroke
What is being tested?
Functional Electrical Stimulation Cycling, Cognitive Task Training and Transcutaneous Auricular Photobiomodulation
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
150 participants
Where
No sites listed yet
Study dates
1 Dec 2026to 1 Oct 2028
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 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults aged 20 to 80 years.
  • First-ever ischemic or hemorrhagic stroke with unilateral impairment in hand or arm strength or motor function.
  • Medically stable and able to participate safely in the training program.
  • Able to understand the study procedures and sign the informed consent form.
  • Able to follow verbal instructions, comply with study procedures, and complete all assessments.
  • Able to maintain a seated position and participate in each training session (approximately 40-60 minutes).

Who cannot join

  • Stroke involving the brainstem or cerebellum.
  • History of epilepsy, photosensitive epilepsy, or a tendency to faint.
  • Presence of implanted electronic devices, such as pacemakers, implantable cardioverter-defibrillators (ICD), or other electronic medical implants (e.g., artificial heart, infusion pumps, cochlear implants).
  • Wounds, infections, or significant skin problems at potential stimulation sites (ear or scalp).
  • Presence of major psychiatric disorders or inability to understand or cooperate with testing.
  • Cardiovascular or vascular-related conditions, including severe heart disease, uncontrolled arrhythmia, or medical advice against exercise; use of anticoagulant medication that makes laser stimulation inappropriate.
Show all 12Show fewer
  • Acute illness, such as fever or active infection.
  • Botulinum toxin injections or relevant surgeries within the past six months.
  • Photosensitive disorders (e.g., lupus, porphyria) or current use of photosensitizing medications.
  • Inability to safely perform cycling training (e.g., recent fractures, severe spasticity, difficulty maintaining seated posture).
  • Pregnant or breastfeeding individuals.
  • Any other condition deemed unsuitable by the study physician (e.g., severe claustrophobia).

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

About this study

Official title: Exploratory Evaluation of Neuromodulation Combined With Dual Functional Electrical Stimulation Cycling and Cognitive Task Training on Cognitive-Motor Performance in Individuals After Stroke

This study will evaluate the effects of functional electrical stimulation (FES) cycling, cognitive task training, and non-invasive photobiomodulation on cognitive and upper-limb motor performance in adults after stroke. The study includes three stages to identify favorable FES cycling and neuromodulation approaches and to evaluate their combined effects. Participants will complete 10 intervention sessions over 2 weeks. Cognitive and motor outcomes will be assessed before treatment, immediately after treatment, and at 3-month follow-up. Feasibility, tolerance, and adverse events will also be evaluated.

Read the detailed description

This is a three-stage, randomized, sham-controlled study in individuals after stroke. Stage 1 will compare FES cycling alone, FES cycling combined with cognitive task training, and sham FES cycling. Stage 2 will compare photobiomodulation applied to the ear, forehead, and sham stimulation. Stage 3 will evaluate the selected FES cycling and neuromodulation approaches alone and in combination. Participants will complete 10 sessions over 2 weeks. Cognitive, upper-extremity motor, functional, participation, and quality-of-life outcomes will be assessed at baseline, immediately after treatment, and at 3-month follow-up. Feasibility, adherence, tolerance, and adverse events will also be monitored.

Conditions
Stroke
Being tested
Functional Electrical Stimulation Cycling, Cognitive Task Training, Transcutaneous Auricular Photobiomodulation, Transcutaneous Forehead Photobiomodulation, Sham Functional Electrical Stimulation Cycling
Keywords
Functional Electrical Stimulation, FES Cycling, Photobiomodulation, Neuromodulation, Cognitive Task Training, Dual-Task Training, Upper Extremity Rehabilitation, Cognitive-Motor Performance, Stroke Rehabilitation
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Functional Electrical Stimulation CyclingDevice

    FES-assisted arm cycling is provided for approximately 40 minutes per session, 5 sessions per week for 2 weeks.

  • Cognitive Task TrainingBehavioural

    Cognitive tasks are performed during FES cycling and progressively target attention, working memory, and executive control.

  • Transcutaneous Auricular PhotobiomodulationDevice

    Photobiomodulation is applied to the outer ear for approximately 20 to 30 minutes.

  • Transcutaneous Forehead PhotobiomodulationDevice

    Photobiomodulation is applied to the forehead for approximately 20 to 30 minutes.

  • Sham Functional Electrical Stimulation CyclingDevice

    Participants receive the sham FES cycling control condition.

  • Sham PhotobiomodulationDevice

    Participants receive the sham photobiomodulation control condition.

  • Optimal FES Cycling ProtocolOther

    The FES cycling condition associated with the most favorable cognitive-motor performance pattern in Stage 1 will be selected for use in Stage 3. The selected protocol will consist of either FES cycling alone or FES cycling combined with cognitive task training.

  • Optimal Neuromodulation ProtocolDevice

    The photobiomodulation condition associated with the most favorable cognitive-motor performance pattern in Stage 2 will be selected for use in Stage 3. The selected protocol will consist of either transcutaneous auricular photobiomodulation (taPBM) or transcutaneous forehead photobiomodulation (tfPBM).

Study groups in NCT07807176
Study groupRoleWhat they receive
Stage 1: FES Cycling AloneExperimentalParticipants receive FES-assisted arm cycling.
Receives: Device: Functional Electrical Stimulation Cycling
Stage 1: Dual-Task FES CyclingExperimentalParticipants receive FES-assisted arm cycling combined with cognitive task training.
Receives: Device: Functional Electrical Stimulation Cycling; Behavioral: Cognitive Task Training
Stage 1: Sham FES CyclingPlacebo comparatorParticipants receive sham FES cycling.
Receives: Device: Sham Functional Electrical Stimulation Cycling
Stage 2: Auricular PhotobiomodulationExperimentalParticipants receive transcutaneous auricular photobiomodulation (taPBM).
Receives: Device: Transcutaneous Auricular Photobiomodulation
Stage 2: Forehead PhotobiomodulationExperimentalParticipants receive transcutaneous forehead photobiomodulation (tfPBM).
Receives: Device: Transcutaneous Forehead Photobiomodulation
Stage 2: Sham PhotobiomodulationPlacebo comparatorParticipants receive sham photobiomodulation.
Receives: Device: Sham Photobiomodulation
Stage 3: Optimal FES Cycling + Sham NeuromodulationExperimentalParticipants receive the optimal FES cycling protocol identified in Stage 1 combined with sham neuromodulation.
Receives: Device: Sham Photobiomodulation; Other: Optimal FES Cycling Protocol
Stage 3: Optimal Neuromodulation + Sham FES CyclingExperimentalParticipants receive the optimal neuromodulation protocol identified in Stage 2 combined with sham FES cycling.
Receives: Device: Sham Functional Electrical Stimulation Cycling; Device: Optimal Neuromodulation Protocol
Stage 3: Optimal FES Cycling + Optimal NeuromodulationExperimentalParticipants receive the optimal FES cycling protocol combined with the optimal neuromodulation protocol.
Receives: Other: Optimal FES Cycling Protocol; Device: Optimal Neuromodulation Protocol
Stage 3: Sham FES Cycling + Sham NeuromodulationPlacebo comparatorParticipants receive sham FES cycling combined with sham neuromodulation.
Receives: Device: Sham Functional Electrical Stimulation Cycling; Device: Sham Photobiomodulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Trail Making Test-Part B (TMT-B)

    The TMT-B assesses executive function and cognitive flexibility. Longer completion times indicate poorer executive function and cognitive flexibility.

    Measured: Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).

  2. Intra-Extra Dimensional Shift (IED)

    The IED assesses set-shifting ability and cognitive flexibility. Fewer errors indicate better performance.

    Measured: Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).

  3. Rapid Visual Information Processing (RVP)

    The RVP assesses sustained attention. Higher accuracy indicates better sustained attention.

    Measured: Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).

  4. Digit Span Test

    The Digit Span Test assesses working memory and sustained attention. Higher span scores indicate stronger working memory and sustained attention.

    Measured: Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).

  5. Fugl-Meyer Assessment-Upper Extremity (FMA-UE)

    The FMA-UE assesses upper-extremity motor control. Scores range from 0 to 66, with higher scores indicating better motor control.

    Measured: Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).

  6. Action Research Arm Test (ARAT)

    The ARAT assesses upper-limb functional performance. Scores range from 0 to 57, with higher scores indicating better upper-limb function.

    Measured: Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).

Secondary outcomes (14)
  1. Montreal Cognitive Assessment (MoCA)

    The MoCA assesses cognitive functioning across domains including attention, executive function, memory, and visuospatial skills. Scores range from 0 to 30, with higher scores indicating better cognitive functioning.

    Measured: Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).

  2. Trail Making Test-Part A (TMT-A)

    The TMT-A assesses processing speed and attention. Longer completion times indicate poorer processing speed and attention.

    Measured: Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).

  3. Symbol Digit Modalities Test (SDMT)

    The SDMT assesses processing speed. More correct responses indicate better processing speed.

    Measured: Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).

  4. Spatial Working Memory (SWM)

    The SWM assesses working memory. Fewer errors indicate better working memory performance.

    Measured: Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).

  5. Paired Associates Learning (PAL)

    The PAL assesses visual learning. Fewer errors indicate better visual learning performance.

    Measured: Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).

  6. Modified Ashworth Scale (MAS)

    The MAS assesses muscle spasticity. Scores range from 0 to 4, with higher scores indicating greater spasticity.

    Measured: Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).

  7. Grip and Pinch Dynamometry

    Grip and pinch dynamometry measures upper-extremity muscle strength. Higher force output indicates greater muscle strength.

    Measured: Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).

  8. Box and Block Test (BBT)

    The BBT assesses gross manual dexterity. More blocks transferred indicate better gross manual dexterity.

    Measured: Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).

  9. Nine-Hole Peg Test (9HPT)

    The 9HPT assesses fine motor coordination. Shorter completion times indicate better fine motor coordination.

    Measured: Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).

  10. Motor Activity Log (MAL)

    The MAL assesses use of the affected arm in daily activities and perceived quality of movement. Scores range from 0 to 5, with higher ratings indicating greater daily arm use and better movement quality.

    Measured: Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).

  11. ABILHAND Questionnaire

    The ABILHAND Questionnaire assesses perceived manual ability in daily activities. Higher logit scores indicate better perceived manual ability.

    Measured: Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).

  12. Functional Independence Measure (FIM)

    The FIM assesses functional independence. Scores range from 18 to 126, with higher scores indicating greater functional independence.

    Measured: Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).

  13. Stroke Impact Scale (SIS)

    The SIS assesses the impact of stroke on functional recovery. Domain scores range from 0 to 100, with higher scores indicating better functional recovery.

    Measured: Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).

  14. Stroke-Specific Quality of Life Scale (SS-QOL)

    The SS-QOL assesses stroke-specific health-related quality of life. Higher scores indicate better health-related quality of life.

    Measured: Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Sep 2026
  2. Study start1 Dec 2026 (estimated)
  3. Primary completion1 Oct 2028 (estimated)
  4. Study completion1 Oct 2028 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07807176
Sponsor's protocol ID
202502050A3
Status last verified
Sep 2026
First submitted
2 Sep 2026
Last updated
5 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Functional Electrical Stimulation Cycling, Cognitive Task Training and Transcutaneous Auricular Photobiomodulation in people with Stroke, run by Chang Gung Memorial Hospital.

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 6 inclusion and 12 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: opening soon, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 Chia-Ling Chen (+883-3-3281200 ext. 8148, clingchen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Trail Making Test-Part B (TMT-B) (time frame: Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).). The study lists 6 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 5 Nov 2026.

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