Stroke
Conditions
Keywords
Functional Electrical Stimulation, FES Cycling, Photobiomodulation, Neuromodulation, Cognitive Task Training, Dual-Task Training, Upper Extremity Rehabilitation, Cognitive-Motor Performance, Stroke Rehabilitation
Brief 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.
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.
Interventions
DEVICEFunctional Electrical Stimulation Cycling
FES-assisted arm cycling is provided for approximately 40 minutes per session, 5 sessions per week for 2 weeks.
BEHAVIORALCognitive Task Training
Cognitive tasks are performed during FES cycling and progressively target attention, working memory, and executive control.
DEVICETranscutaneous Auricular Photobiomodulation
Photobiomodulation is applied to the outer ear for approximately 20 to 30 minutes.
DEVICETranscutaneous Forehead Photobiomodulation
Photobiomodulation is applied to the forehead for approximately 20 to 30 minutes.
DEVICESham Functional Electrical Stimulation Cycling
Participants receive the sham FES cycling control condition.
DEVICESham Photobiomodulation
Participants receive the sham photobiomodulation control condition.
OTHEROptimal 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.
DEVICEOptimal 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).
Sponsors
Chang Gung Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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).
Exclusion criteria
* 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. * 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Action Research Arm Test (ARAT) | Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2). | The ARAT assesses upper-limb functional performance. Scores range from 0 to 57, with higher scores indicating better upper-limb function. |
| Trail Making Test-Part B (TMT-B) | Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2). | The TMT-B assesses executive function and cognitive flexibility. Longer completion times indicate poorer executive function and cognitive flexibility. |
| Intra-Extra Dimensional Shift (IED) | Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2). | The IED assesses set-shifting ability and cognitive flexibility. Fewer errors indicate better performance. |
| Rapid Visual Information Processing (RVP) | Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2). | The RVP assesses sustained attention. Higher accuracy indicates better sustained attention. |
| Digit Span Test | Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2). | The Digit Span Test assesses working memory and sustained attention. Higher span scores indicate stronger working memory and sustained attention. |
| Fugl-Meyer Assessment-Upper Extremity (FMA-UE) | Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2). | The FMA-UE assesses upper-extremity motor control. Scores range from 0 to 66, with higher scores indicating better motor control. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Grip and Pinch Dynamometry | Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2). | Grip and pinch dynamometry measures upper-extremity muscle strength. Higher force output indicates greater muscle strength. |
| Box and Block Test (BBT) | Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2). | The BBT assesses gross manual dexterity. More blocks transferred indicate better gross manual dexterity. |
| Nine-Hole Peg Test (9HPT) | Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2). | The 9HPT assesses fine motor coordination. Shorter completion times indicate better fine motor coordination. |
| Montreal Cognitive Assessment (MoCA) | Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2). | 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. |
| ABILHAND Questionnaire | Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2). | The ABILHAND Questionnaire assesses perceived manual ability in daily activities. Higher logit scores indicate better perceived manual ability. |
| Functional Independence Measure (FIM) | Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2). | The FIM assesses functional independence. Scores range from 18 to 126, with higher scores indicating greater functional independence. |
| Stroke Impact Scale (SIS) | Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2). | The SIS assesses the impact of stroke on functional recovery. Domain scores range from 0 to 100, with higher scores indicating better functional recovery. |
| Stroke-Specific Quality of Life Scale (SS-QOL) | Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2). | The SS-QOL assesses stroke-specific health-related quality of life. Higher scores indicate better health-related quality of life. |
| Motor Activity Log (MAL) | Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2). | 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. |
| Trail Making Test-Part A (TMT-A) | Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2). | The TMT-A assesses processing speed and attention. Longer completion times indicate poorer processing speed and attention. |
| Symbol Digit Modalities Test (SDMT) | Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2). | The SDMT assesses processing speed. More correct responses indicate better processing speed. |
| Spatial Working Memory (SWM) | Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2). | The SWM assesses working memory. Fewer errors indicate better working memory performance. |
| Paired Associates Learning (PAL) | Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2). | The PAL assesses visual learning. Fewer errors indicate better visual learning performance. |
| Modified Ashworth Scale (MAS) | Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2). | The MAS assesses muscle spasticity. Scores range from 0 to 4, with higher scores indicating greater spasticity. |
Contacts
CONTACTChia-Ling Chen
STUDY_DIRECTORChia-Ling Chen
Chang Gung Memorial Hospital
Outcome results
None listed