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Neuromodulation Combined With Dual FES Cycling and Cognitive Training After Stroke
Sponsor: Chang Gung Memorial Hospital
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. 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.
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
Key Details
Gender
All
Age Range
20 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2026-10-01
Completion Date
2028-10-01
Last Updated
2026-09-08
Healthy Volunteers
No
Conditions
Interventions
Functional Electrical Stimulation Cycling
FES-assisted arm cycling is provided for approximately 40 minutes per session, 5 sessions per week for 2 weeks.
Cognitive Task Training
Cognitive tasks are performed during FES cycling and progressively target attention, working memory, and executive control.
Transcutaneous Auricular Photobiomodulation
Photobiomodulation is applied to the outer ear for approximately 20 to 30 minutes.
Transcutaneous Forehead Photobiomodulation
Photobiomodulation is applied to the forehead for approximately 20 to 30 minutes.
Sham Functional Electrical Stimulation Cycling
Participants receive the sham FES cycling control condition.
Sham Photobiomodulation
Participants receive the sham photobiomodulation control condition.
Optimal FES Cycling Protocol
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 Protocol
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).