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Neuromodulation Combined With Dual FES Cycling and Cognitive Training After Stroke

3 novembre 2026 aggiornato da: Chang Gung Memorial Hospital

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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

150

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 20 anni a 80 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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).

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Stage 1: FES Cycling Alone

Participants receive FES-assisted arm cycling.
Dispositivo: Functional Electrical Stimulation Cycling

FES-assisted arm cycling is provided for approximately 40 minutes per session, 5 sessions per week for 2 weeks.
Sperimentale: Stage 1: Dual-Task FES Cycling

Participants receive FES-assisted arm cycling combined with cognitive task training.
Dispositivo: Functional Electrical Stimulation Cycling

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

Comportamentale: Cognitive Task Training

Cognitive tasks are performed during FES cycling and progressively target attention, working memory, and executive control.
Comparatore placebo: Stage 1: Sham FES Cycling

Participants receive sham FES cycling.
Dispositivo: Sham Functional Electrical Stimulation Cycling

Participants receive the sham FES cycling control condition.
Sperimentale: Stage 2: Auricular Photobiomodulation

Participants receive transcutaneous auricular photobiomodulation (taPBM).
Dispositivo: Transcutaneous Auricular Photobiomodulation

Photobiomodulation is applied to the outer ear for approximately 20 to 30 minutes.
Sperimentale: Stage 2: Forehead Photobiomodulation

Participants receive transcutaneous forehead photobiomodulation (tfPBM).
Dispositivo: Transcutaneous Forehead Photobiomodulation

Photobiomodulation is applied to the forehead for approximately 20 to 30 minutes.
Comparatore placebo: Stage 2: Sham Photobiomodulation

Participants receive sham photobiomodulation.
Dispositivo: Sham Photobiomodulation

Participants receive the sham photobiomodulation control condition.
Sperimentale: Stage 3: Optimal FES Cycling + Sham Neuromodulation

Participants receive the optimal FES cycling protocol identified in Stage 1 combined with sham neuromodulation.
Dispositivo: Sham Photobiomodulation

Participants receive the sham photobiomodulation control condition.

Altro: 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.
Sperimentale: Stage 3: Optimal Neuromodulation + Sham FES Cycling

Participants receive the optimal neuromodulation protocol identified in Stage 2 combined with sham FES cycling.
Dispositivo: Sham Functional Electrical Stimulation Cycling

Participants receive the sham FES cycling control condition.

Dispositivo: 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).
Sperimentale: Stage 3: Optimal FES Cycling + Optimal Neuromodulation

Participants receive the optimal FES cycling protocol combined with the optimal neuromodulation protocol.
Altro: 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.

Dispositivo: 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).
Comparatore placebo: Stage 3: Sham FES Cycling + Sham Neuromodulation

Participants receive sham FES cycling combined with sham neuromodulation.
Dispositivo: Sham Functional Electrical Stimulation Cycling

Participants receive the sham FES cycling control condition.

Dispositivo: Sham Photobiomodulation

Participants receive the sham photobiomodulation control condition.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Trail Making Test-Part B (TMT-B)
Lasso di tempo: 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.
Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).
Intra-Extra Dimensional Shift (IED)
Lasso di tempo: 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.
Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).
Rapid Visual Information Processing (RVP)
Lasso di tempo: 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.
Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).
Digit Span Test
Lasso di tempo: 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.
Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).
Fugl-Meyer Assessment-Upper Extremity (FMA-UE)
Lasso di tempo: 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.
Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).
Action Research Arm Test (ARAT)
Lasso di tempo: 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.
Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Montreal Cognitive Assessment (MoCA)
Lasso di tempo: 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.
Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).
Trail Making Test-Part A (TMT-A)
Lasso di tempo: 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.
Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).
Symbol Digit Modalities Test (SDMT)
Lasso di tempo: 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.
Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).
Spatial Working Memory (SWM)
Lasso di tempo: 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.
Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).
Paired Associates Learning (PAL)
Lasso di tempo: 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.
Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).
Modified Ashworth Scale (MAS)
Lasso di tempo: 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.
Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).
Grip and Pinch Dynamometry
Lasso di tempo: 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.
Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).
Box and Block Test (BBT)
Lasso di tempo: 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.
Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).
Nine-Hole Peg Test (9HPT)
Lasso di tempo: 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.
Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).
Motor Activity Log (MAL)
Lasso di tempo: 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.
Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).
ABILHAND Questionnaire
Lasso di tempo: 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.
Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).
Functional Independence Measure (FIM)
Lasso di tempo: 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.
Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).
Stroke Impact Scale (SIS)
Lasso di tempo: 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.
Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).
Stroke-Specific Quality of Life Scale (SS-QOL)
Lasso di tempo: 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.
Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Chang Gung Memorial Hospital

Investigatori

  • Direttore dello studio: Chia-Ling Chen, Chang Gung Memorial Hospital

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 dicembre 2026

Completamento primario (Stimato)

1 ottobre 2028

Completamento dello studio (Stimato)

1 ottobre 2028

Date di iscrizione allo studio

Primo inviato

2 settembre 2026

Primo inviato che soddisfa i criteri di controllo qualità

2 settembre 2026

Primo Inserito (Effettivo)

8 settembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

5 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

3 novembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 202502050A3

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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