An interventional study of Functional Electrical Stimulation Cycling and Cognitive Task Training in Stroke, sponsored by Chang Gung Memorial Hospital. Not yet recruiting. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Chang Gung Memorial Hospital · Not applicable, Interventional, and Treatment
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.
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.
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
This study's planned enrollment of 150 is above the median of 49 across 6,024 interventional studies indexed under Stroke.
Browse Stroke studies →Chang Gung Memorial Hospital is the lead sponsor of 1,096 studies on the registry; 239 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive FES-assisted arm cycling.
Device: Functional Electrical Stimulation Cycling
Participants receive FES-assisted arm cycling combined with cognitive task training.
Device: Functional Electrical Stimulation Cycling · Behavioral: Cognitive Task Training
Participants receive sham FES cycling.
Device: Sham Functional Electrical Stimulation Cycling
Participants receive transcutaneous auricular photobiomodulation (taPBM).
Device: Transcutaneous Auricular Photobiomodulation
Participants receive transcutaneous forehead photobiomodulation (tfPBM).
Device: Transcutaneous Forehead Photobiomodulation
Participants receive sham photobiomodulation.
Device: Sham Photobiomodulation
Participants receive the optimal FES cycling protocol identified in Stage 1 combined with sham neuromodulation.
Device: Sham Photobiomodulation · Other: Optimal FES Cycling Protocol
Participants receive the optimal neuromodulation protocol identified in Stage 2 combined with sham FES cycling.
Device: Sham Functional Electrical Stimulation Cycling · Device: Optimal Neuromodulation Protocol
Participants receive the optimal FES cycling protocol combined with the optimal neuromodulation protocol.
Other: Optimal FES Cycling Protocol · Device: Optimal Neuromodulation Protocol
Participants receive sham FES cycling combined with sham neuromodulation.
Device: Sham Functional Electrical Stimulation Cycling · Device: Sham Photobiomodulation
FES-assisted arm cycling is provided for approximately 40 minutes per session, 5 sessions per week for 2 weeks.
Cognitive tasks are performed during FES cycling and progressively target attention, working memory, and executive control.
Photobiomodulation is applied to the outer ear for approximately 20 to 30 minutes.
Photobiomodulation is applied to the forehead for approximately 20 to 30 minutes.
Participants receive the sham FES cycling control condition.
Participants receive the sham photobiomodulation control condition.
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.
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).
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.
Time frame: Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).
Intra-Extra Dimensional Shift (IED)
The IED assesses set-shifting ability and cognitive flexibility. Fewer errors indicate better performance.
Time frame: Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).
Rapid Visual Information Processing (RVP)
The RVP assesses sustained attention. Higher accuracy indicates better sustained attention.
Time frame: Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).
Digit Span Test
The Digit Span Test assesses working memory and sustained attention. Higher span scores indicate stronger working memory and sustained attention.
Time frame: Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).
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.
Time frame: Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).
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.
Time frame: Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).
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.
Time frame: Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).
Trail Making Test-Part A (TMT-A)
The TMT-A assesses processing speed and attention. Longer completion times indicate poorer processing speed and attention.
Time frame: Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).
Symbol Digit Modalities Test (SDMT)
The SDMT assesses processing speed. More correct responses indicate better processing speed.
Time frame: Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).
Spatial Working Memory (SWM)
The SWM assesses working memory. Fewer errors indicate better working memory performance.
Time frame: Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).
Paired Associates Learning (PAL)
The PAL assesses visual learning. Fewer errors indicate better visual learning performance.
Time frame: Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).
Modified Ashworth Scale (MAS)
The MAS assesses muscle spasticity. Scores range from 0 to 4, with higher scores indicating greater spasticity.
Time frame: Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).
Grip and Pinch Dynamometry
Grip and pinch dynamometry measures upper-extremity muscle strength. Higher force output indicates greater muscle strength.
Time frame: Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).
Box and Block Test (BBT)
The BBT assesses gross manual dexterity. More blocks transferred indicate better gross manual dexterity.
Time frame: Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).
Nine-Hole Peg Test (9HPT)
The 9HPT assesses fine motor coordination. Shorter completion times indicate better fine motor coordination.
Time frame: Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).
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.
Time frame: Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).
ABILHAND Questionnaire
The ABILHAND Questionnaire assesses perceived manual ability in daily activities. Higher logit scores indicate better perceived manual ability.
Time frame: Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).
Functional Independence Measure (FIM)
The FIM assesses functional independence. Scores range from 18 to 126, with higher scores indicating greater functional independence.
Time frame: Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).
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.
Time frame: Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).
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.
Time frame: Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).
No study locations are listed for this record.
Start is estimated for Dec 2026; primary completion for Oct 2028, 22 months later.
Of 3,108 non-industry interventional studies with no phase under Stroke, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 46. This study's planned 22 months is close to that.
Counting every sponsor, half of 3,252 studies reached it within 23 months; a quarter within 10 and three quarters within 46.
Start moved once since we started tracking on Sep 25, 2026: Oct 2026 → Dec 2026, on Nov 5, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Chang Gung Memorial Hospital →