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Neuromodulation Combined With Dual FES Cycling and Cognitive Training After Stroke

3. november 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

150

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

20 år til 80 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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).

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Stage 1: FES Cycling Alone

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

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

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

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

Atferdsmessig: Cognitive Task Training

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

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

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

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

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

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

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

Participants receive sham photobiomodulation.
Enhet: Sham Photobiomodulation

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

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

Participants receive the sham photobiomodulation control condition.

Annen: 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.
Eksperimentell: Stage 3: Optimal Neuromodulation + Sham FES Cycling

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

Participants receive the sham FES cycling control condition.

Enhet: 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).
Eksperimentell: Stage 3: Optimal FES Cycling + Optimal Neuromodulation

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

Enhet: 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).
Placebo komparator: Stage 3: Sham FES Cycling + Sham Neuromodulation

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

Participants receive the sham FES cycling control condition.

Enhet: Sham Photobiomodulation

Participants receive the sham photobiomodulation control condition.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Trail Making Test-Part B (TMT-B)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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).

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Montreal Cognitive Assessment (MoCA)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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).

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Chang Gung Memorial Hospital

Etterforskere

  • Studieleder: Chia-Ling Chen, Chang Gung Memorial Hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. desember 2026

Primær fullføring (Antatt)

1. oktober 2028

Studiet fullført (Antatt)

1. oktober 2028

Datoer for studieregistrering

Først innsendt

2. september 2026

Først innsendt som oppfylte QC-kriteriene

2. september 2026

Først lagt ut (Faktiske)

8. september 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

5. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

3. november 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 202502050A3

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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